Bio2Business is pleased to welcome Almac as an exhibitor sponsor at BOS Basel 2020, which will take place on the 1st and 2nd of July, 2020, at the Congress Centre Basel in Switzerland. The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally.
Dr Firelli Alonso, Senior Director, External Supply, BioTherapeutics & Vaccines Outsourcing, Pfizer, will present in the Biologics CMC Outsourcing work-stream at BOS Basel 2020. Her confirmed presentation title is "Agile sourcing strategies for new therapeutic modalities".
Bio2Business is delighted to welcome Solara Active Pharma Sciences as an exhibitor at BOS Basel 2020. Solara Active Pharma Sciences provides CDMO Services and is an API Manufacturer. With over 5 Manufacturing Sites and 2 R&D Centers, Solara offers a production range from a milligram to metric ton level. As a CDMO, Solara specializes in tech transfer, analytical development, route scouting, GMP Manufacturing and Commercial Supply.
EUROFINS AMATSIGROUP
Eurofins CDMO is a leading international Contract Development and Manufacturing Organization (CDMO). Our company focuses on API/drug substance and drug product development for chemical/biological entities.
We support small and major biopharmaceutical companies in an innovative way to help them achieving their (pre)clinical milestones timely.
Our solid track record in developing and manufacturing New Biological Entities (NBE)/New Chemical Entities (NCE) is one of our strongest asset.
We are experts in breakthrough technologies for highly potent compounds, poorly soluble drugs, lyophilisation processes and specific therapeutic areas (immunotherapies, orphan drugs, paediatric dosage forms...). Our facilities are perfectly designed for small batches either for sterile or non-sterile dosage forms.
Involved in the earliest steps, our highly-qualified project management team will propose a complete drug development strategy in compliance with regulations.
Frequent communication through one single point of contact, flexibility, troubleshooting mindset, customized solutions, will help our clients to speed up their drug development process.
Our goal is to build a sustainable partnership with our customers to support their drug development pathway.
Our services:
- Drug Substance development
- Solid state
- Pre-formulation, Formulation development
- Analytical support (R&D, QC)
- Non-GMP and GMP Manufacturing
- Clinical packaging and logistics
- Project management I CMC RA
Contact us:
cdmo@eurofins.com
www.eurofins.com/cdmo
Contact details:
Elena Bejan
Vice President - Research & Development - Eurofins CDMO/Eurofins Alphora
Philippe Martel
Senior Business Development Manager - Eurofins CDMO/Eurofins Amatsigroup
Andreas Wendt
Senior Business Development Manager - Eurofins CDMO/Eurofins Amatsigroup
Cheryl Young
Director, Business Development and Project Management - Eurofins CDMO/Eurofins Alphora
Legacy Pharmaceuticals is a Swiss contract manufacturer and service provider (CMO) specializing in fill/finish of sterile and semi-solid drug products for the global pharmaceutical industry.
Legacy was originally founded in 1947, has been privately owned since 2007 and is approved by SWISSMEDIC, US FDA, and PMDA. The company is able to meet the stringent regulatory requirements in the various markets around the world - products currently manufactured by Legacy on behalf of our clients are sold in 112 countries world-wide.
STERILE FILL FINISH
Legacy Pharmaceuticals has expertise in sterile fill/finish of liquid and powder Drug Products in vials, as well as liquid DPs in ampoules, and can handle small molecules, biologicals, highly potent and controlled drugs. We are also equipped for thermal final sterilization.
Our parenteral products are efficiently 100% inspected for visible particles (ampoules and vials) and for integrity (ampoules) using automated equipment.
For secondary packaging, we offer a broad spectrum of fully automated packaging equipment, all the way up to customer-specific manual packaging.
Legacy is currently expanding its capabilities to managing the lyophilization process in vials, in response to increasing demand from industry both for this drug product format and prefilled syringe fill finish to align with the market need for self-injection.
SERVICES PORTFOLIO OVERVIEW
We offer customized services to our customers for every phase of the product life cycle. With our specialized team, we support you with product transfer and obtain all basic materials for you. You are in good hands for your ICH-compliant stability tests, and these can be adjusted to your individual needs.
Our Regulatory Affairs team supports you in preparing the technical registration dossier for submission to regulators. Our many years of experience also help you with distribution.
Services include:
- Drug Registration
- Qualification and Validation
- ICH Stability Testing
- Distribution Support/Services
- Product Transfer
- Procurement Services
Thermo Fisher Scientific's Patheon and Fisher Clinical Services brands provide industry-leading solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes. With more than 40 locations around the world, the company can provide integrated, end-to-end capabilities across all phases of development, including API, biologics, formulation, clinical trials solutions, logistics services and commercial manufacturing.
Solvias is a world leader in contract research, development and manufacturing with headquarters near Basel, Switzerland. Over 500 highly qualified employees work as a team to deliver unrivaled expertise, service and value to our customers in the pharmaceuticals, biotech, medical devices and cosmetics industries. Drawing on our well-established scientific experience and proven track record, we develop, analyze and test a wide range of biological and chemical substances, enabling our customers to deliver safer and better products to the market faster.
Sterling Pharma Solutions Ltd (stand 37)
Sterling Pharma Solutions has over 50 years' experience serving the global pharmaceutical industry, (large, small and virtual), from our North-East England base. Offering state-of-the-art facilities, a wide variety of chemistry capabilities and experienced people, we have a proven track record in the supply of chemistry and analytical services across the entire product lifecycle. We offer full grams to tonnes service and support products from pre-clinical through to commercial supply.
Our world-class safety and quality standards are globally recognised and demonstrated through successful MHRA and FDA inspections and a CIA Diamond Award for Safety over the last ten years. This enables challenging
chemistries, (fluorinations, cryogenics, high-pressure reductions and carbonylations), to be carried out safely and successfully, along with the capacity and capability to handle highly potent molecules and controlled drugs.
We pride ourselves on our customer focus and service approach, offering flexible, tailored solutions to meet our clients' needs and requirements.
Mike Smallwood; mike.smallwood@sterlingpsl.com
Business Development Director
Sterling Pharma Solutions Ltd
Dudley, Cramlington
Northunberland, NE23 7QG
United Kingdom
Tel: +44 191 250 4021 (Sales Assistant)
Tel: +44 7740 619 354 (Mobile)
Fax: +44 191 250 1154 (Office)
Almac Group, an established contract development and manufacturing organisation, provides the most unique range of integrated drug development services available to the pharmaceutical & biotech industry.
A privately owned organisation that has grown over 50 years, we now employ over 5,000 high skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with 17 global facilities across the UK, Ireland, USA and Asia.
Our quality, innovation and efficiency are testimony to over 600 companies worldwide who trust Almac for their Chemical, Pharmaceutical and Clinical Development needs.
Addressing the increasing pressure for Biopharma companies to bring their clinical candidates through their pipeline faster, more efficiently and at a lower cost, Almac provides an integrated CMC service, bridging the gap between drug substance and drug product development.
As an established provider of both drug substance (advanced intermediates and Active Pharmaceutical Ingredients - small molecules and peptides) and drug product development services, and by offering these within an integrated package, our client partners are assured of scientific continuity from a dedicated project team, resulting in significant savings in time and costs.
Integrated teams within Chemical and Pharmaceutical Development work closely to fully understand the physicochemical properties of the API to ensure the optimum chemical entity is available for the manufacture of clinical supplies.
Whether your requirements are for First in Human supplies or later phase development, manufacture or registration batches, Almac have access to a wide range of innovative technologies for potent and non-potent, solid oral dose products.
Having integrated chemical and pharmaceutical development operations, facilitates optimal communication and knowledge transfer on projects. Our clients leverage this combined offering, exploiting the Almac advantage of a single partner approach. Smoothing transition through the drug development process and commercialisation saves time, transfers and other uncertainties inherent in a multi-supplier process.
CARBOGEN AMCIS AG is a leading service provider, offering a portfolio of drug development and commercialization services to the pharmaceutical and biopharmaceutical industries at all stages of drug development. Our integrated services for Drug Substances (DS) and Drug Products (DP) provide innovative solutions to support timely and safe drug development. CARBOGEN AMCIS is also active in the marketing/sales and manufacture of Vitamin D analogues, Vitamin D, Cholesterol and lanolin related products for key markets as pharmaceutical, cosmetic, food, feed as well as industry applications.
Our flexible approach enables customers to benefit from tailored packages of work which balance their needs in terms of speed, cost and quality. CARBOGEN AMCIS also adapts their communication and reporting to match customer specific requirements and documentation. CARBOGEN AMCIS has been part of Dishman Carbogen Amcis Limited since 2006.
Quality is central to the CARBOGEN AMCIS business. We provide services for the development and manufacture of highly potent drug substances (APIs) and drug products applying state-of-the-art containment technologies.
CARBOGEN AMCIS offers services starting from laboratory scale for process research and development purposes up to large scale manufacturing. To support the API development process through all stages, a variety of high containment analytical and purification capabilities complements the chemistry service portfolio. In addition to our process research and manufacturing services for the fast supply of highly potent APIs, CARBOGEN AMCIS offers conjugation services for Antibody Drug Conjugates (ADCs) as well as formulation and fill-and-finish services for drug products.
CARBOGEN AMCIS mission is to provide innovative solutions for drug development and supply to the pharmaceutical and biopharmaceutical industries that enable customers to bring new generation medicines to the market.
www.carbogen-amcis.com
Fareva is a top 5 CDMO globally with 40 production sites around the world focusing on drug substance and drug product development and manufacturing.
Highlights of Fareva Corporate:
- 5th largest CDMO in world by revenue
- 1.6 billion revenue in 2018
- 40 Production Sites and more than 12,000 Employees
Highlights of Fareva API:
- cGMP small molecule manufacturing for clinical programs and commercial production
- First and only company in the world to receive SafeBridge Certification to handle high potent drug substance and drug product at the same facility
- Milling and Micronization
- Aseptic processing of APIs (crystallization, micronization and packaging of API)
- Programs range from 1kg to 50MT annually
- World class process chemistry team
- High potent and cytotoxic APIs
- Steroids
- Conventional APIs (not potent)
- PSD and Polymorph control
- Global registrations (100+ DMFs in US, Canada, Japan, Europe)
- Sterilization of API by Ethylene Oxide
- Experience across a broad range of chemical classes - more than 200 different molecules
Highlights of Fareva Formulation and Drug Product Manufacturing:
- Ophtalmic forms (BFS, conventional and preservative-free bottles)
- Injectables (freeze-dried vials, ampoules and pre-filled syringes)
- Aerosols (conventional and bag on valve) and sprays (mechanical, preservative free)
- Suspensions, solutions and gels (bottles, sachets and stick-packs)
- Granules and powders (sticks packs, sachets, bottle); tablets (uncoated, coated, sugar coated) and capsules (blisters and bottles) with cytoxic expertise
-Creams, ointments, gel and jellies (single dose, sachets, alu, polyfoil or plastic tubes); sterile ointments and gels (polyfoil or aluminium tubes)
- Suppositories & ovulas
- Food supplements; herbal tea (grade pharma or not)
- Narcotics management and expertise (3 sites)
LGC is a global leader in the life sciences sector. We provide a comprehensive range of reference materials, proficiency testing schemes, genomics reagents and instrumentation, research and measurement services.
Our Drug Development Solutions business helps pharma, biotech, CROs/CDMOs, medical device and consumer healthcare companies provide assurance and high quality data to support their discovery, development and manufacture activities.
With cGMP labs in the UK, Germany and US and a track record of success in regulatory audits, including the FDA, we support the regulatory Chemistry, Manufacturing and Control (CMC) compliance of your drug substance and drug product through the complex challenges faced in drug development, solving issues at all stages of manufacture. Our CMC services cover a broad range of physical and chemical method development and testing capabilities with Centres of Excellence in Material Science and Impurity and Contamination Analysis.
In addition, with one of the world’s largest bioanalytical centres, recognised for leadership in science and technology, LGC has comprehensive capabilities for pharmacokinetics, immunogenicity and biomarkers that span LC-MS/MS through to immunoassay, cell and molecular biology. We routinely solve difficult method development challenges and, as your development progresses from discovery through to GLP preclinical and to GCP clinical trials, we have the capacity, rapid turnaround and logistics needed to support the largest, most complex protocols.
For a full range of services offered visit www.lgcgroup.com/dds
LGC. Science for a safer world.
Minakem is a leading supplier of pharmaceutical fine chemicals.
With R&D, Quality Control & Assurance, production and regulatory affairs services, we offer a complete range of CDMO services from development to production of APIs, HPAPIs, cGMP advanced intermediates, Generic APIs and catalogue/custom building blocks, from grams to multi tons (Total capacity = 290 m3).
We have a proven track record in our capability to take projects from early stage through to commercial manufacture.
In trusted long-term partnerships, we enable pharmaceutical and biotechnological companies to support and speed-up the development and production of innovative treatments of the highest quality to their patients globally.
We can offer number of technologies including highly potent handling (up to class 6), solid chemistry, industrial preparative chromatography, flow chemistry expertise coupled with photochemistry and electrochemistry.
We operate three FDA approved sites in France and Belgium.
contact-MHP@minakem.com
contact@minakem.com
Novasep provides flexible contract development & manufacturing (CDMO) solutions for Small Molecule APIs & Biopharmaceuticals to innovators. We offer a wide range of flexible cGMP manufacturing assets on multiple sites with an outstanding regulatory track record.
We are a world leader in a number of technologies including industrial chromatography (batch and continuous), hazardous & cryogenic chemistry, HPAPIs, ADCs & Viral Vectors.
Novasep has recently invested over >100mEuro to expand its commercial manufacturing footprint including:
- ADCs: A new 11mEuro¬ bioconjugation unit in Le Mans, France.
- Viral Vectors: Senrise-IV, a new 27mEuro facility for AAV, Adenovirus, Lentiviral vectors, HSV... in Seneffe, Belgium.
- Fill & Finish: Senefill, a new 10mEuro facility for aseptic Fill & Finish operations for viral vectors, viruses, plasmids and other biologics in Seneffe, Belgium.
Have a look at our website to learn more about our services: www.novasep.com
- And to contact us: novasep@novasep.com
Quality Assistance - Your one-stop shop for analytical services
Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. The company holds a unique position on the market with all its laboratories on one site, 190 highly qualified professionals and more than 35 years’ expertise at the forefront of analytical sciences. We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.
For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.
Quality Assistance is an expert for the development of biologics (monoclonal antibodies, ADCs, proteins), New Chemical Entities (e.g. peptides, oligonucleotides), nanomedicine products, vaccines, Cell-Based and Gene Therapy Medicinal Products. Quality Assistance environment is GMP, GLC, GCLP/GCP compliant. Visit www.quality-assistance.com to learn more on our expertise and services as a leading analytical CRO and make sure you pass by at our stand #30.
Quay Pharmaceuticals is experienced in providing a comprehensive out-sourcing service for formulation and analytical development with subsequent clinical trials and commercial manufacturing for pharmaceutical and
biotechnology companies world-wide.
Working as a dedicated, pro-active part of your team we apply strong project management and technical expertise to take products quickly and cost effectively from late stage pre clinical through to the end of phase III clinical trials and Commercial Manufacturing.
Quay Pharma has vast expertise in dosage form design and development and with Prof Mike Rubinstein, Prof John Collett (CSO) and Prof Larry Gifford Quay Pharma has built a reputation for specialising in the formulation of API's that exhibit poor solubility and bio-availability and those which require modified or controlled release. This has resulted in many Quay Pharma clients successfully licensing products on to large, global pharmaceutical companies.
From MHRA and FDA licensed inspected facilities the
company provides;
- pre-clinical to commercial formulation development
- novel drug delivery system design
- analytical - transfer or method development and validation
- live biotherapeutic drug delivery
- ICH stability testing
- clinical trial manufacture in class 100,000 (ISO8) environment
- conventional, coated and controlled
release tablets and capsules
- powder, liquid / semi-solid fill capsules
- liquid /semi solid formulations (e.g. nasal and oral solutions, creams)
- pellets / spheroids and extrudates
- medical devices
- commercial manufacturing
- packing and labelling
- full QC testing services
- QP certification and importation of investigational medicinal products from outside the EU.
- CMC's and regulatory document support for product registration
Quay Pharma holds a Manufacturing Authorisation from the MHRA for the manufacture and testing of investigational medicinal products (IMP’s), as specified by the EU Clinical Trials Directive (2001/20/EC) and also possesses a "Specials" licence.
For further information contact:
Michael Kruidenier
Head of Business Development
Telephone: +44 (0) 1244 837 004
Email: m.kruidenier@quaypharma.com
Website: www.quaypharma.com
Solara Active Pharma Sciences, a leading Contract organization from India, offers drug discovery, development, manufacturing and commercialization services to advance their partners ongoing research, from Concept to Commercialization. Our experienced pool of scientists, are backed by 5 manufacturing sites and 2 dedicated R&D centres. While our manufacturing sites have been successfully audited by the USFDA for 22 times, we have also been audited by other regulatory agencies like EDQM, AGES (Austria), KFDA (Korea), EU-GMP (Danish), MHRA, Cofepris (Mexico) and PMDA (Japan). Our facilities are also certified with ISO 14001:2004 and ISO 45001:2018.
Solara’s scientists have impeccable experience of over three decades, enabling Solara to provide Contract Research and Manufacturing Services (CRAMS) from discovery to late phase commercial manufacturing in Full Time Equivalent and Fee for Service models respectively. Our capabilities include route scouting, process development and optimization, tech transfer, salt / polymorph screening and GMP manufacturing.
AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI's team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical Services, API Manufacturing and Drug Product. We've got it down to an exact science.
We care about the quality and success of your projects as if they were our own. No matter the size of your project or the complexity of the challenge, our experts pinpoint and execute the precise solution to hit your target. From molecule to molecule, batch to batch, your product will benefit from our ingenuity.
Arcinova is a Contract Development and Manufacturing Organisation that helps pharmaceutical and biotechnology companies across the globe develop life changing medicines. We employ a multidisciplinary approach to drug development by combining the disciplines of chemistry, biology and bioinformatics. All our services are delivered from our 15,000m2 facility in the North of England.
We leverage our decades of experience as a key research and development centre for Sanofi and Covance to deliver high quality end-to-end solutions. Our mission is to deliver best-in-class technology services in the fields of contract research, development and small-scale manufacturing to overcome project challenges and increase efficiency.
BioConnection B.V. (www.bioconnection.eu) is a Dutch CMO which offers flexible state-of-the-art development and GMP compliant manufacturing services for sterile Drug Products in batch sizes ranging from a few vials (manual fill) up to 75.000 vials (automated fill). BioConnection is specialized in Fill and Finish including freeze drying, technology transfers, scale-up and validations. BioConnection offers complete Drug Product manufacture service packages based on tailor made solutions and customer-oriented flexibility from its own facility in Oss (which is EMA and US FDA certified) in cooperation with various best-in-class partners. BioConnection supplies its clients (since 2005) with injectable Drug Products (e.g. vials and syringes) for either clinical trial programs and/ or commercial purposes.
Chiral Quest (www.chiralquest.com) is a leading Chinese CMO founded in 2000 with expertise in asymmetric hydrogenation, multi-step synthesis and cryogenic reactions.
Our headquarters and R&D centre are located in Suzhou, with commercial scale manufacture in Jiangxi Province. Chiral Quest offers flexible, state-of-the-art commercial manufacture (to GMP if required) and has successfully developed and scaled up multiple processes for API intermediates, up to n-1.
Our manufacturing site has a capacity of over 550,000L including 12 pressure vessels for asymmetric hydrogenation and 10 cryogenic vessels. This allows production from 100’s kg to metric ton quantities
In September 2018 we passed our first US FDA audit.
Contact details:
Ian Stansfield,
Senior Director, Business Development, Europe
istansfield@chiralquest.com
m: +44(0)7881636705
BIO2BUSINESS LTD. London BioScience Innovation Centre, 2 Royal College Street, London. NW1 0NH. Tel: +44 (0)207 691 3568
BOS Media pack for 2020 events
