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Speaker Profiles - Small Molecule Stream
Dr Aline Sondenecker, Business Development Manager,
Bachem Branch Vionnaz
Dr.Aline Sondenecker is Business Development and Project Manager at Bachem SA, Branch Vionnaz, located inSwitzerland, the non-peptidic arm of the Bachem group focused on the development and production of small organic molecule APIs and Highly Potent APIs (HPAPIs). As Business Development Manager she is responsible for the promotion of the custom manufacturing activities inScandinavia,Germany,Switzerland,ItalyandEastern Europe. As Project Leader, Aline is managing a number of different small organic molecule API and HPAPI projects from process transfer, scale-up and validation activities to cGMP production campaign.
Aline studied chemistry atNeuchâtelUniversity, Switzerlandand then received her Ph.D. in organometallic chemistry at the Swiss Federal Institute of Technology Zürich (ETHZ). Her research topic was mainly in the areas of the heterogeneous catalysis, especially asymmetric hydrogenation using ferrocenyl bis(phosphanes) combining three elements of chirality (C-central, P-central and planar) as catalyst.
Bachem, the Swiss-based world’s leading manufacturer of peptides has also a longstanding experience in the development and production of small molecule active pharmaceutical ingredients (APIs), NCEs as well as generic APIs and HPAPIs.
Bachem’s site at Vionnaz is specialized in the development and production of our small-molecule products.
Our state-of-the-art technology equipment and highly-qualified staff allow us to synthesize your small molecule active ingredient in any scale, from gram amounts for research to tons under cGMP-conditions. The Vionnaz facility is regularly inspected by the competent regulatory authorities. The most active compounds can be produced in our high containment unit at the site (down to OEL < 0.1µg/m3/8h). As our offer includes all the required regulatory documentation and related services, we will support you during the complete process of drug development.
Bachem has already submitted a large number of CMC documentations in support of successful IMPD and IND applications.
If you are interested in additional information, and would like to become more familiar with our company and services please visit us at our booth or listen to the presentation of Dr. Aline Sondenecker “Sustainable Partnership for Your Challenging Projects” given during the small molecule track.
Rene Holm, Head of Department, Preformulation,
H Lundbeck A/S
René Holm received his pharmaceutical training at the Royal Danish School of Pharmacy, now the Pharmaceutical Faculty at the University of Copenhagen, Denmark, in 1998, and his PhD in biopharmaceutics from the same institution in 2002. Dr Holm joined Lundbeck in 2001, and worked within pharmaceutical development until 2006 where he moved into preformulation responsible for the physical chemical characterisation and input, both in liquid and solid state from drug discovery, over development and trouble shooting in production with eg polymorphism. Dr Holm is (co-)author of more than 30 original articles in peer-reviewed journals in the field of biopharmaceutics and preformulation and is named as (co-)inventor of 5 patents within the same fields.
“Science driven pharmaceutical developability assessment and translation into formulations for first human dose”
Quality be design (QbD) and risk based assessment of the pharmaceutical developability is useful tools when selecting compounds in the late stage discovery and in the definition of the pharmaceutical development strategy. This presentation will present a short description of a decision three from first human dose until clinical proof of concept based upon simple in vitro measures and nonclinical in vivo experiments, all as a part of derisking the pharmaceutical development.
Mr Torbjörn Larsson, Director of Pharmaceutical R&D,
Medivir AB
Torbjörn Larsson received his university training at Uppsala University and got a BSc in Chemistry (mainly Biochemistry) in 1984; In addition to that he has received training in biotechnology and Industrial Pharmaceutics at Uppsala University. Mr Larsson joined Kabi Vitrum (later integrated into Pharmacia and Pharmacia & Upjohn(P&U)) and worked in process development of APIs based on proteins and carbohydrates. By the end of the 1980íes he turned into project management and later project co-ordination and was during this time involved in projects at most phases of drug development. During 1997-98 Mr Larsson managed the group responsible for Quality Assurance on P&Us biotech API plant in Strängnäs, Sweden. Late 1998 Mr Larsson joined Medivir AB as Director CMC (later Supply/CMC) and was responsible for the CMC-part of development in all projects at Medivir including Xerclear which involved the submissions and approvals in EU and US and launch in the Nordic area. During the last two years Mr Larsson has been part of the commercial organisation being responsible for the supply chain, mainly for Xerclear. In September 2011 Mr Larsson joined the Research and Development Department as Director Pharmaceutical R&D (Which involves development of both drug substances and drug products).
Dr Christoph Rosenbohm, Director, Chemistry & CMC,
Santaris Pharma A/S
Christoph Rosenbohm is responsible for managing the company’s chemistry activities including in-house synthesis of both novel analogues and oligonucleotides, synthesis of non GMP and GMP material at CMO, analytical chemistry and project management.
He is author and co-author of than 30 scientific publications and patents. M. Sc. and Ph.D. in chemistry were obtained from the University of Southern Denmark with Prof. Jesper Wengel – one of the inventors of LNA - as supervisor. In addition he is an MBA graduate of the Copenhagen Business School.
When a lead candidate is moved towards clinical trials a reliable supply chain is needed. Synthesis and analysis are outsourced to CMOs, and a close knowledge based partnership needs to be established between sponsor and CMO. The talk will focus on the outsourcing process – what and when to outsource and is there a benefit for the research organization from the outsourcing.
Dr Alexander Strätz , Sales Manager,
CARBOGEN AMCIS
Dr Alexander Strätz is Sales Manager at Switzerland-based CARBOGEN AMCIS, a Dishman Group Company. He holds a PhD in metallorganic chemistry from theUniversityofCologne, where he focused on developing new platinum complexes as precursor for chemical vapor deposition (CVD) processes.
Alexander’s strong functional expertise on GMP production and validation of APIs and intermediates is further built on more than 10 years working within the pharmaceutical and chemical industry. Prior to joining CARBOGEN AMCIS, Alexander worked as a Business Development Manager for the Group Novasep SAS where he gained hands-on experience on custom development and manufacturing of APIs and Highly Potent APIs (HPAPIs) and chromatography. Previous assignments also include several positions in the sales Organization of Acros Organics (Thermo Fisher Scientific).
In his new role as Sales Manager at CARBOGEN AMCIS, Alexander is responsible for business development in Scandinavia, The Netherlands and Eastern Europe and focuses on the coordination of CMC activities related to API and HPAPIs development and manufacturing on customers’ behalf.
Switzerland-based CARBOGEN AMCIS, a pharmaceutical process development and Active Pharmaceutical Ingredient (API) manufacturing company, has expanded its range of development and manufacturing services by adding complementary capabilities for drug products, from highly dosed through to highly potent small molecules and biologics. At the Riom, France site, CARBOGEN AMCIS offers services for injectable, liquid and semi-solid pharmaceutical forms such as e.g. the formulation of new products, the optimization of existing formulations and the development and optimization of lyophilization cycles. The sites features a 400-square meter GMP production area with clean rooms dedicated to the production of parenteral drugs in vials, syringes, cartridges and infusion bags to support preclinical studies and clinical trials (Phase I, II & III).
CARBOGEN AMCIS’ combined capabilities and services for drug products and drug substances present a one-stop solution to pharmaceutical, biotech and virtual companies looking for a single reliable partner for their preclinical and clinical studies.
If you want to learn more about our new capabilities and services, attend our show case during the small molecule track: “Services beyond Drug Substance Manufacture” held by Dr. Alexander Strätz, Sales Manager CARBOGEN AMCIS or visit us at our booth!
Dr Lars Olsson, CMC Director, Clinical Development,
Karo Bio AB
Lars Olsson studied at Stockholm University and finished with a Ph.D. in Organic Chemistry in 1996. After a few years as a post-doc overseas Lars joined AstraZeneca in Södertälje in 1999. Throughout 7 years there Lars worked with various aspects of development of API processes and delivery of API to clinical studies. In 2007 Lars joined Medivir as a CMC specialist and has later continued as such at Acadia and presently at Karo Bio. In these biotech companies Lars has managed projects both in the area of Drug Substance and Drug Product.
Eprotirome is a thyroid hormone analog that was developed for treatment of dyslipidemia. Development of a commercially viable tablet formulation met a number of challenges. These included stability and compatibility issues, in-vivo formation of a reactive metabolite and the low dose to be given. In addition to technical details the talk will also discuss scale-up and technology transfer as well as some regulatory aspects. The topics will be considered from the view of a development department at a smaller biotech company.
Mr Sören Olsson, Director, New Products, Cambrex Karlskoga,
Cambrex
Mr Sören Olsson has been with Cambrex for 33 years. Over this period, he has held the position as Manager R&D Analysis for 15 years and Project Leader Strategic Projects for two years. Since 2003, Sören has been the Director R&D New Products with primary responsibility for project management. Prior work experience includes time with Billerud as a Chemical Engineer.
High Energy Capabilities at Cambrex Karlskoga
Cambrex's expertise in high energy compounds and hazardous materials dates back to the work of Alfred Nobel and his founding the site in Karlskoga, Sweden in 1896. Since then, our continuous application and improvement of highly energetic processes and dedication to quality has laid a solid foundation for our energetic development work and cGMP compliant manufacturing capabilities. Since unwanted side reactions might result in severe injury to personnel and equipment, the development and manufacture of high energy compounds requires extra attention to safety screening procedures and process safety management. Cambrex continues to successfully develop and manufacture many highly energetic APIs and pharmaceutical intermediates for the pharmaceutical industry.
Dr Andrew Lamb, Business Development Manager,
BASF Custom Synthesis
Andrew Lamb has nearly 15 years’ experience working in contract R&D and manufacturing services for the Pharmaceutical industry.
Following a PhD in synthetic organic chemistry, specialising in carbohydrates as chiral pool molecules for natural product synthesis, Andrew joined ChiRex as a development chemist, with responsibility for developing new routes to clinical-phase and commercial APIs and introducing new processes to pilot and manufacturing plants. On leaving the lab, he gained further experience in Project and Product management, initially coordinating all aspects of multi-disciplinary technology transfers from lab to plant for clients in Europe and theUSA, before managing the company’s proprietary chiral technologies.
More recently, Andrew has had commercial roles in diverse drug development and discovery services providers, including 3 years initiating the European business for an Indian CRO and 2 years in the sales team for a multinational integrated drug development services provider.
He joined BASF in 2010, and has responsibility for Business Development inNorthern Europefor the Custom Synthesis business, which provides API development and manufacturing support, and forms part of BASF’s broad range of chemistry solutions for the Pharma and Biotech Industry worldwide.
Mr Brian Eastwood, Business Development Manager, Pharmaceutical Development,
Almac
Brian joined Almac Pharma Services, part of Almac Group, in May 2010. His role is to develop the business and marketing strategy for the company’s Pharmaceutical Development, Clinical & Commercial Manufacturing and Product Launch services.
Prior to joining Almac, Brian worked as Corporate Business Manager for a local Healthcare company for four years after gaining almost ten years experience working within the R&D department at Norbrook Laboratories Ltd. Brian holds a Bachelor of Science (Hons) degree in Biochemistry from the Queens University, Belfast and a Masters of Science degree in Biotechnology from University of Ulster, Coleraine.
Dr Joe Carey, Head of Contract Manufacturing & BD,
Tillotts Services
Dr Joe Carey is Head of Contract Manufacturing Services & Business Development at Tillotts Services, a CRO/CMO business subsidiary within Tillotts Pharma AG. Dr Carey is an organic chemist by training and has spent much of his career within the pharmaceutical and biotechnology industries where he has held senior technical and commercial roles within Shell Research, Pfizer Central Research, Chiroscience Group PLC and BTG PLC. He was previously CEO of Encap Drug Delivery before joining Tillotts in January 2010 to restructure and expand their contract manufacturing business. In October 2010 Tillotts Services was launched at CPhI with a new, focused CRO service offering and building upon the company’s specialist capability in liquid-fill encapsulation using two-piece, hard-shell capsules which has been a core capability for over 26 years. Tillotts Services is the world’s leading supplier of liquid-filled capsules and is based in Ziefen, nearBasel,Switzerlandand is currently expanding its facilities. Joe has a B.Sc. in chemistry (Class I) from theUniversityofSussex, a D.Phil in organic chemistry from theUniversityofOxfordand an MBA from theUniversityofCambridge.
Lipid Self-Dispersing Formulations
to Improve Biopharmaceutical Properties of Weak Soluble Compounds
The development of lipid-based oral drug delivery formulations for capsules is normally driven by the desire to increase and/ or make reproducible the oral bioavailability of poorly aqueous soluble molecules showing erratic and variable pharmacokinetic profiles after the oral administration of conventional solid forms. Lipid-based formulations range from simple oily solutions to complex mixtures of oils, surfactants, co-surfactants and co-solvents, classified as lipid self-emulsifying (SEDDS) or micro-emulsifying drug delivery systems (SMEDDS). Due to their ability to maintain the active molecule dissolved and/or to prevent precipitation in vivo, self-dispersing lipid formulations are of high pharmaceutical interest for improving biopharmaceutical properties of active molecules. This presentation will give a short overview of the development methodology of lipid self-dispersing formulations for hard shell capsules, covering important bio-relevant in vitro tests for assessing the formulation performance. Moreover, the state of the art instruments and equipment available at Tillotts Services from early development up to large scale industrial manufacturing will be briefly presented, as well as our systematic development approach will be shared.
Dr Satish Nigam, Director Sales & Marketing,
GVK Biosciences Pvt Ltd
Satish Nigam, Ph.D.
Dr. Satish Nigam is currently the Director of Sales & Marketing at GVK Biosciences Pvt. Ltd., a renowned CRO in Hyderabad, India, and looks after the sales for Discovery services viz. Chemical Synthesis, Biology, Process Development and Custom synthesis. At GVK BIO, we provide Contract Research Services to a rapidly growing base of global pharmaceutical and biotechnology companies by combining Science, Innovation and People to help our clients address their drug development challenges.
Satish Nigam received his Ph.D. from University of Delhi, Delhi and followed it with a Post-Doctoral Fellowship at Centre de Neurochimie du CNRS, Strasbourg, France working with Prof. C.G.Wermuth and later at Pharmaceutical Chemistry Department , University of Kansas, Lawrence, Kansas, USA working with Prof. Ronald Borchardt, both in the field of Neurochemistry. He specializes in Process Chemistry and has been extremely successful in developing several new routes for new and existing molecules and taking NCE through Phase-I to launch while working in Fine Chemical and CRO Industry in US. He has over twenty years’ experience of working in GMP and controlled environment with APIs (preclinical to commercial), Advanced Intermediates, DEA Controlled Substances, High Potency Drug substances, Radiolabelled compounds besides being involved in the commercial scale synthesis of Chiral Molecules (cryogenic) and Biocatalytic transformations. He has authored twelve Papers and ten Process Patents.
Dr Violeta Marmon, Director,
Bio-T Consulting Ltd
Violeta Marmon is a senior CMC consultant and recently founded Bio-T Consulting Ltd. Previously she was a head of CMC at Prosidion Ltd. UK. She studied organic chemistry at Sofia University, Bulgaria and then received a Ph.D. in organic chemistry and biotechnology at the Institute of Organic Chemistry, Moscow, Russia. Violeta has over 17 years of experience in the pharmaceutical industry and led projects for OSI Pharmaceuticals US (oncology) and Prosidion UK (diabetes and obesity) through all phases of CMC development to commercialisation. Violeta managed a considerable number of manufacturing campaigns, process transfers, scale up and validation activities, carried out technical audits, preparations for PAI inspections, and due diligence activities in-house and for external clients.
Speaker Profiles - Biologics Stream
Dr Oliver Schub, Business Development Manager,
ProBioGen AG
Dr Oliver Schub is a scientist by training and gradually transitioned from the lab into business development.
Since 03-2008: With ProBioGen AG (Berlin, Germany), a Contract Development and Manufacturing Organization (CDMO) to promote suitable technologies & services to client partners for industrial production of their animal cell-derived biologics (therapeutic proteins and viral vaccines).
2004-2008: Lab Head of Baculovirus Protein Expression and Project Manager at PSF Biotech AG (Spin-Off form “Protein Structure Factory”,Berlin), a service provider for structure-based drug design.
2001-2004: Postdoc at University of Toronto, Canada, Dept. of Medical Genetics, Brenda Andrews lab on CDK-mediated regulation of G1/S transcription in Eukaryotes (S.cerevisiae).
PhD in Biochemistry on Cyclin-dependent kinase-mediated regulation of human DNA replication initiation in vitro (SV40 system) (IMB Jena, Germany).
Diploma Chemist; Diploma thesis on protein folding of a snake venom from inclusion bodies in E.coli (Both University Regensburg, Germany) For details see LinkedIn.
Dr Joel Richard, Vice President Peptides, CMC & Engineering,
IPSEN – Beaufour Ipsen Industrie
Dr Joël Richard is Vice President, Peptides in Ipsen (Dreux, France). He is globally leading the development of both injectable peptide products and orally-administered small molecules, with major franchises in oncology, endocrinology and neurology. Dr Richard’s previous experience includes positions as:
- Vice-President, Drug Product Development in Ipsen, Dreux, France
- Director of Pharmaceutical Development in Serono and MerckSerono, Rome, Italy.
- Vice – President Research, and Europe R&D Director at Ethypharm, Saint-Cloud, France.
- Chief Operating Officer (COO) and R&D Director at Mainelab, Angers, France, a start-up company specialised in protein formulation and delivery technology that he co-founded with Pr Jean-Pierre Benoit.
Dr Richard graduated from Ecole Normale Supérieure, Cachan, France in 1985, and received his Ph.D. degree in Materials Science, from the University of Paris, France in 1987. Since 1996, Dr Richard has focused his research activity on injectable proteins and peptides. Dr Richard has published more than 60 peer-reviewed scientific papers, 7 book chapters and 2 review editorials in various fields. He is the co-author of 70 international communications and 50 patent families.
The market for biologics is expected to undergo significant changes in the next years. It should be strongly impacted by the increasing number of products coming off patent, the development of biosimilars and the levellling off of the number of new products reaching the market. In this particular context, competition between biotech companies is continuously increasing, which motivates companies for product improvement and differentiation. Significant product improvements will likely be based on a careful identification and a better control of the critical quality attributes of commercial formulations, so as to set-up higher quality standards, hence raising the standards for biosimilars as regards quality, immunogenicity and manufacturability. This step will require the availability and further development of a wide set of orthogonal and constantly improving characterization methods to identify degradation pathways, understand aggregation processes and elucidate the presence of particulates of various size (sub-micron, sub-visible and visible particles). The objective will be to get a comprehensive mapping of the characteristics of aggregates and particulates and an in-depth characterization, using the appropriate combination of orthogonal analytical and biophysical methods. More particularly, the monitoring and characterization of micron-size particulatess will become a key challenge to develop a risk-based approach of immunogenicity and establish the relationship between aggregates/particulates and immunogenicity for the commercial formulations.
As regards product differentiation, long-acting injectable protein therapeutics appear as one of the most attractive new dosage forms for biotech companies. The significant interest for these new forms is well justified, since they could strongly improve patient compliance and quality of life by reducing frequency of injection, and in the same time provide the patient with an improved safety profile and a higher efficacy. Basically, two different routes can be explored to achieve a long-acting profile of protein therapeutics. The first approach that has already been successful, is based on protein engineering, such as post-translational modifications (PEGylation, glyco-engineering, . . .) and fusion with other proteins, peptides, Fc fragments or parts of receptors to increase the apparent half life of the protein. These techniques lead to a redesign of the molecule, thus creating a new molecular entity with the associated hurdles on the way to registration related to new safety/immunogenicity profile and full clinical development. The other approach relies on sustained-release depot formulations. This is considered as very attractive since it does not require the chemical modification of the proteins. These formulations consist of gels, micro- and nanoparticles made of biodegradable or natural polymers and lipids, or even solid implants. However, both poor protein stability in the manufacturing processes and complexity of these processes, as well as generally low core loading and limited injectability through thin needles, have made this route hardly successful so far, with regard to the number of new products that have effectively reached the market.
This talk will review the main strategies proposed to support product improvement and differentiation, and provide recent examples of already successful and promising strategies and technologies to achieve this goal.
Dr Aimee Cossins, Group Leader Analytical and Formulation Development,
Syntaxin Ltd
Dr Aimee Cossins is Group Leader, Analytical & Formulation Development at Syntaxin Ltd. Aimee’s main role is to manage the development and transfer of IPC, release, stability and characterisation assays to support process development and manufacture of recombinant proteins from Syntaxin’s novel TSI (Targeted Secretion Inhibitor) platform. Aimee is also responsible for designing and managing pre-formulation, characterisation and stability studies for TSI candidates. These roles involve a significant amount of CMO and CRO management. Aimee joined Syntaxin Ltd shortly after it was spun-out from the UK's Health Protection Agency (HPA), and has continued with the company since as it has expanded and developed.
“Challenges and opportunities presented by outsourcing analytical and formulation assays; a small biotech view”
Many biopharmaceutical companies; large, small and virtual, operate outsourcing strategies to deliver analytical and formulation capability for both Research and Development. The reasons for deciding whether to outsource or not to outsource are many, and vary according to task, cost, timeline, internal capability, compliance status and many other factors. The perspective of a small biotech, Syntaxin Ltd, for outsourcing such analytical assays will be presented. Syntaxin has a unique R&D biologics platform, which can influence selection of which work packages to outsource and which service providers to use. This presentation will include the importance and methods of relationship management and strategies to maximise effectiveness, value and compliance. The potential issues and difficulties that may be encountered will also be presented.
Dr Monica Malerba, Manufacturing Coordinator,
NovImmune SA
Monica Malerba joined NovImmune in January 2010 as manufacturing co-ordinator.
She holds a PhD in Molecular Biology obtained at the University Louis Pasteur in Strasbourg in 2006. She subsequently completed her scientific training with two postdoctoral positions at the University of California Irvine and the University of Geneva.
A concise biotechnology industry training course allowed her to gain experience in project management and product development before taking on the responsibility of coordinating all internal and outsourced manufacturing activities for NovImmune SA, in particular being the point of contact for NovImmune’s fill finish CMO.
Title:
Formulating successful outsourcing partnerships: Sponsor & vendor perspectives on managing fill/finish
Abstract:
The multi-domain, three-dimensional nature of monoclonal antibodies (mAb) coupled with the added complexity of the manufacturing make process and formulation development challenging yet essential steps during drug development. Their success is even more critical for a small biotech company outsourcing Drug Product (DP) GMP manufacturing. Due to the seven therapeutic mAb pipeline, Novimmune has faced and surmounted these challenges by working in close collaboration with the fill/finish CMO.
One of NovImmune’s therapeutic mAb presented manufacturability issues during the early phase of development, with three consecutive clinical DP lot release failures endangering the future development of the drug. The initial DP manufacture failure revealed elevated sub-visible particle formation, which could be resolved by the addition of polysorbate 80 at 0.02% in a histidine buffered formulation. However the two subsequent batches failed due to a drop in activity coupled with a sharp rise in aggregates. An investigation conducted to elucidate physical and chemical events at the origin of these failures demonstrated that the cause of the activity drop was the oxidation of tryptophan (30%) and methionine (14%) in the CDRH3 and CH2, respectively. This oxidation was demonstrated to be dose-dependent in function of polysorbate 80 concentration.
Working alongside the DP manufacturer, we have been able to resolve these manufacturability issues by optimizing the Polysorbate 80 concentration and implementing modifications in the DP manufacturing process. The Polysorbate 80 content was reduced to a concentration allowing for the benefits of its surfactant properties whilst removing detrimental effects. In parallel, in order to minimize air /oxygen contact, the diluent solution was degassed before use, vials were filled to their maximum capacity and the remaining head space was N2 purged. In addition, in order to prevent contact with leachables, using stainless steel material was avoided.
A deep understanding of the mAb oxidation mechanisms gained from investigational studies performed at NovImmune was essential for the identification of critical DP process parameters. Good communication and a close working interaction between NovImmune and the fill/finish CMO has been the key driver towards a successful manufacturing strategy.
Dr Christina Jespersgaard, Development Scientist Protein Separation and Virology,
Novo Nordisk A/S
Christina Jespersgaard holds a PhD in Medicine from The University of Aarhus.
She joined Novo Nordisk in 2006 working with identification and purification of new biological entities. Over the years she has specialized in downstream process development and currently holds a position as Sr. Development Scientist in Protein Separation and Virology, CMC Supply, Novo Nordisk. This job involves development and optimization of scalable downstream process steps in laboratory scale for purification of recombinant proteins for early and late phase projects, preparing documentation needed for project progress and participation in transfer of processes to pilot/production/outsourcing partner.
Christina has gained more than 10 years of experience in the industry from employments at Dako, CMC Biologics and Novo Nordisk A/S.
Programme managing a robust large-scale antibody production. How to effectively collaborate with a CMO partner during technical transfer and production to achieve speed and quality.
During the development and production of a particular monoclonal antibody for Phase I/II clinical trials, it became apparent that production facilities internally at Novo Nordisk were unavailable. Consequently, a production facility agreement for this specific production was signed with a Novo Nordisk preferred CMO partner and technical transfer was initiated. This presentation explores the challenges of keeping highly aggressive timelines without compromising on product quality, and includes important learnings on the subject of technical transfer and collaborations in general to be considered by future outsourcing companies.
Dr Daniel Ozanne, Senior Business Development Manager,
Fujifilm Diosynth Biotechnologies
Dr Ozanne has over ten years' experience in the biologics contract development and manufacturing market with commercial roles with Biovation/Merck KGaA (Darmstadt), Accuro Biologics (UK) and Catalent Pharma Solutions (USA). He has experience in the placing of novel technology in new markets for both mammalian and microbial cell line expression systems. Dr Ozanne joined Fujifilm DB in August 2011 with responsibility for growth of business in defined European markets within the biologics division of the Company. Dr Ozanne has a PhD in Molecular Oncology from Newcastle University and an MBA from Aberdeen Business School.
Dr Antti Vuolanto, VP Production,
Oncos Therapeutics
Antti Vuolanto is Vice President, Production, and co-founder at Oncos Therapeutics Ltd. He is responsible of all CMC-related activities at Oncos including production, production development and scale-up.
Oncos develops new cancer therapies based on its next generation oncolytic adenoviruses. Currently, a Phase I trial is ongoing inFinland. The company’s unique Advanced Therapy Access Program (ATAP) was started in 2007 for treatments of cancer patients in whom standard-of-care therapies have failed. After over 800 administered treatments, the ATAP data has laid a solid foundation for optimized, data-driven clinical development of lead agent CGTG-102.
Vuolanto holds a Doctor of Science degree in Bioprocess Engineering fromAaltoUniversityinHelsinki. Previously Vuolanto has over ten years of experience in biotech including the development of different bioprocesses, productization and commercialization of in vitro diagnostics, and startup business development.
Oncos develops new cancer therapies based on its next generation oncolytic adenoviruses, which kill cancer cells by targeted virus replication and mediate immunologic response against the tumor. The company’s unique hospital exemption use program was started in 2007 for treatments of cancer patients in whom standard-of-care therapies had failed. After over 800 administered treatments, the treatment program data have laid a solid foundation for optimized, data-driven clinical development of lead agent CGTG-102 with strong safety data and promising supportive evidence on survival benefit. The clinical development of the lead agent is currently in Phase I inEurope, with two further trials planned to start recruiting in 2012.
Based on its previous in-house experience in virus production, Oncos set up GMP manufacturing in the small scale together with a CMO. Currently, the process delivers GMP compliant IMP for Phase I/II clinical trials. To further support the pivotal trials and commercialization of the oncolytic adenoviruses, Oncos has ongoing process development program aiming at commercial scale production in 2014.
The presentation describes Oncos’ oncolytic adenoviruses, the hospital exemption use treatment data, and CMC strategy to support the commercialization of the viruses.
Dr Mie Hanghøj Grundt Christiansen, Microbiologist,
DB Lab A/S
Mie Christiansen has an MSc in Biochemistry and Molecular Biology from Southern University of Denmark.
Mie joined DB Lab A/S in 2011. DB Lab A/S is an innovative contract laboratory offering chemical and microbiological GMP analyses primarily to the pharmaceutical and biotechnological industries. DB Lab A/S performs tests of pharmaceutical raw materials, intermediates and final preparations. Furthermore DB Lab A/S performs analytical documentation for registration files, method development/transfer/validation, cleaning validation as well as stability testing and storage.
Mie is a Microbiologist in the Microbiology Department with main areas such as microbial quality, suitability tests, identification of bacteria, examination of purified water, measurements of water activity, ingress testing of medical devices and enumeration of probiotic bacteria.
Ms Mara Camillo, Business Development Manager,
Cerbios Pharma
Mara Camillo concluded her biological studies at the Università degli Studi of Milan in 1998. In 1999 Mara joined Grünenthal Italia and in 2001 she moved to Zambon. In these companies she consolidated her work experience as a microbiologist.
In 2003 she joined Cerbios-Pharma SA working in the Microbiological QC department for 8 years. Then, in September 2011 she was appointed as the business development manager for the Biological Division.
Thanks to her expertise and knowledge of Cerbios’ products and activities, she is the ideal interface between customers and potential customers for the contract manufacturing services in the development and production of CHO based recombinant proteins.
New opportunities at Cerbios Pharma: upgrading Biopharmaceutical production capabilities based on recombinant DNA technology
Cerbios strongly believes that Biotechnology will play a more and more significant role in the future of the pharmaceutical industry. This advanced technology is expected to make available more effective drugs and increase the quality of life of patients worldwide.
For this reason, and based on Cerbios’ long-term experience in recombinant DNA technology and resulting recombinant proteins expressed in mammalian cells (CHO), the Company decided to invest in a brand new “state of the art” manufacturing facility dedicated to biopharmaceutical drug substances production under cGMP that will add value to the existing manufacturing units in Cerbios Biological Division.
This facility will allow Cerbios to strengthen its position as a contract manufacturer for the production of New Biological Entities (NBEs).
The facility consists of separate areas for upstream, downstream and critical downstream operations, and is designed with special attention to the optimization of personnel flow and to the control of any potential contamination risks. A separate area is dedicated to the storage of the Master Cell Bank and the Working Cell Bank under cGMP conditions. The new structure will occupy approximately 500m2, of which more than 320m2 are clean rooms, and it is expected to be fully operational and approved by regulatory authorities. Facility design has been approved by Swiss Medic and FDA consultant.
The newly upgraded cGMP manufacturing facility with an advanced high quality infrastructure is designed to accommodate the manufacture of biopharmaceutical active ingredients including, among the others, recombinant proteins and monoclonal antibodies, not only for pre-clinical and clinical phases, but also for commercial use. As a first step the facility bioreactor capacity will be up to 100 liters. This will serve the supply of material for clinical phase I and II. However, the plant is designed for a quick expansion of the capacity up to 500 liters (stainless steel or disposable technology).
The Cerbios R&D team has over 15 years of experience in the field of biotechnology based on recombinant DNA technology and proteins expression in mammalian cells (CHO).
The team’s experience includes cloning of the gene in suitable vectors, transfections, clone selections, setting of culture conditions and optimization of culture media for upstream process development, biochemical experience in purifications for downstream process development, scaling up, setting and validation of analytical methods for in process control, stability and release testing. Thanks to its technology and experience, Cerbios has already successfully developed recombinant proteins such as rUK.
Based on this know-how, Cerbios can offer to its customers full process development starting from a cell line or process optimization after a Technology Transfer. This includes upstream and downstream process development, validations (analytical, process, cleaning), release of the API, stability studies and characterization of the product.
Speaker Profiles - Session Chair
Dr Paul Little , Director of CMC & Preclinical Development,
Orphazyme ApS
Paul Little is Director of CMC and Preclinical Development at Orphazyme ApS (www.orphazyme.com). Orphazyme develops innovative new therapies for the treatment of a family of serious genetic disorders called lysosomal storage diseases. The company was founded in June 2009. Orphazyme is based on discoveries emerging from the academic laboratory of its scientific founders: Professor Marja Jäättela and Thomas Kirkegaard Jensen. Their pioneering work on the cytoprotective properties of human heat shock proteins provides a novel and paradigm-changing approach to developing medicines for the treatment lysosomal storage diseases. Previously Little has over ten years of experience progressing a number of small molecule and peptide projects from discovery to phase II clinical development. From 2008 to 2011 Director of Chemistry, Manufacturing & Controls, at 7TM Pharma A/S. Little holds a PhD, in Benzyne Chemistry from Cardiff University, and was postdoctoral fellow in natural product total synthesis at Nottingham University.
Mr Christian G Houghton, VP, Global Product Development - R&D,
ALK-Abello A/S
Christian G Houghton holds a master’s degree in chemical engineering from the Danish Technical University.
He started his working life at NIRO DDS A/S in 1990 working with process development. In 1994 he moved to ALK-Abelló; the first three years as chemist in Product Development, and from 1997 as Manager of Formulation & Product Development. In 2004 he was appointed Director of Global Product Development, of which he became Vice President in 2011; covering product development, production development and clinical trial supply activities. Concurrently, he’s engaged in work for Danish Medicinal Agency on developing new EP on Allergen Products.
Dr Lena Pereswetoff-Morath, Head of Pharmaceutical and Preclinical Development,
Moberg Derma AB
Lena Pereswetoff-Morath, PhD in Pharmaceutics from Uppsala University, has 18 years of experience from pharmaceutical industry. She worked several years at Astra/AstraZeneca as pharmaceutical project manager for projects in CNS and pain control therapeutic areas and represented Pharmaceutical & Analytical R&D on Global Project Teams. In 2002 Lena joined, as one of the first, the start-up company Biolipox as VP Pharmaceutical Development. She was responsible for all activity in the area of pharmaceutical and analytical development, e.g. supply of API, support to preclinical investigations, out-sourcing of analytical and pharmaceutical development and supplies of products for clinical trials and documentation for regulatory filings. Biolipox was acquired by Orexo AB in 2007. Orexo is a pharmaceutical company focused on developing new, patented drugs by combining well-documented substances with innovative technologies. When the companies merged, Lena was set to lead the Pharmaceutical Innovation and Development organisation. In January 2012 Lena joined Moberg Derma a company that focuses on topical products for skin diseases. Moberg Derma has the same philosophy as Orexo, i.e. the products are based on innovative technology that delivers proven substances in a new way.
Dr Signe Maria Christensen, Outsourcing Manager,
LEO Pharma A/S
Signe Maria Christensen, Ph.D. has more than 10 years of experience with chemical synthesis, scale-up and outsourcing for pharmaceutical industry and biotech companies. Signe joined Leo Pharma in April 2011, and in her position as Outsourcing Manager she is responsible for outsourcing of R&D activities. Before joining Leo Pharma, Signe has held a position as CMC coordinator at NeuroSearch and as Development Chemist at Novo Nordisk. Signe received a Master of Chemical Engineering and a Ph.D. in Organic Chemistry from the Technical University of Denmark
Dr Karsten Lindhardt, VP R&D, Site Head,
Egalet
In his capacity as VP R&D, Site Manager at Egalet Ltd, Denmark, Karsten Lindhardt is responsible for the operational management of all R&D functions in the company. During his more than 11 years of experience in various biotech and pharmaceutical companies he has received hands on experience in drug development and in handling the interaction between Organisation/Project Culture/Risk Management/Value optimization also in virtual company structures. Earlier, he has been Senior Director of Portfolio and Alliance Management at Egalet Ltd. where he came from a position as Senior Clinical Project Manager at Curalogic a/s, Denmark. Before that he was Project Director in Prosidion, UK, that successfully developed NCEs from Discovery to c-PoC. Here he was responsible for the operational development performed through a virtual organisation including ensuring API upscaling (mg scale to multiple kg scale), characterisation, purification, formulation, pre-clinical and early clinical trials using CROs and experts guidance to get two development programs into man. He was deeply involved in the out-licensing activities and, together with colleagues, he managed to make a deal with a large pharmaceutical company. He has also worked in Clinical Pharmacology in Ferring Pharmaceuticals and Novo Nordisk a/s.
Dr Jesper Valbjørn, Senior Director, CMC Operations,
Genmab A/S
Jesper Valbjørn joined Genmab A/S in 2006. He is heading CMC Operations with responsibility for the CMC activities in Genmabs projects from early phase to late phase validated commercial scale. Additionally the unit is responsible for the clinical drug supply logistics and preparation of CMC sections for regulatory filings.
Jesper Valbjørn has 15 years of experience within CMC development in the biopharma industry with positions as project manager, line manager and scientist at H. Lundbeck, Statens Serum Institut and Novo Nordisk.
Jesper Valbjørn holds a MSc in Plant Biochemistry and is inventor of patents in the field of analytical science and process science.
Speaker Profiles - Plenary
Dr Hans Lindner, Global Pharmaceutical Development,
Bayer Pharma AG
Dr Hans Lindner is Head of Global Pharmaceutical Development in Bayer Schering Pharma. It is the central function for formulation, analytical and process development located in Berlin, Germany.
Hans is a pharmacist by training with a doctorate degree in pharmaceutical technology from University of Kiel. He started his industrial career as formulation scientist at Arzneimittelwerk Dresden GmbH, Germany, and later became group leader of the process transfer team. In 1996 he joined Ferring Pharmaceuticals, heading a formulation team in Germany. Later, he became head of formulation teams in Sweden, Denmark and Germany. In 2001 he took over responsibility for the consolidated pharmaceutical development function, joining it in the Ferring Development Center in Copenhagen. In 2004 Hans moved to Schwarz Pharma, Germany, leading the pharmaceutical development organisation. After the merger with UCB S.A. in 2007 he headed Drug Product Development & Industrialisation in Belgium until he joined BSP in 2008. Hans is member of the editorial board of the European Journal of Pharmaceutics and Biopharmaceutics, member of various professional associations and past vice president of the European Association Pharma Biotechnology (EAPB).
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