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SCREENING ASSAYS THAT TRACK AND MONITOR ZEBRAFISH BEHAVIOUR
3Z
Discovery : Small Molecules

3Z developed zebrafish screening assays. Recording up to 2300 larvae in parallel the throughput is immense while gaining high-content information from a whole behaving animal. We specialize in CNS, offering various assays. Currently, we present specifics of our ALS assay. By extended analysis of behavioral parameters we utilize behavior as the ultimate readout of the central nervous system to probe effects of small molecules on CNS activity.

Keywords: Zebrafish, CNS, Small Molecules, Screening

Karl Aegir Karlsson
karlsson@3z.is

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High Content Screening for Cytoskeletal Disrupters
AMRI
Discovery : Small Molecules

Given the known requirement of cytoskeletal dynamics in tumor metastasis, cytoskeletal components have proven to be viable targets of metastatic cancer therapies. Indeed, numerous small molecules and naturally derived products have proven effective in limiting tumor cell proliferation. Despite the success of bringing cytoskeletal dynamic disturbing agents to the cancer therapy market, numerous challenges remain.

Keywords: Cytoskeletal Disrupters, Small Molecules, High Content Screening

Matthew Betzenhauser
Matthew.Betzenhauser@amriglobal.com

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All aboard! Analytical insights fast track your time to market.
Anacura
Analytical : Small Molecules

This poster is an extensions of the oral presentation (Tuesday June 19th, 3 pm) and zooms on shelf-life prediction via ASAP®.

Keywords: shelf-life prediction, stability modelling, ASAP, method development

Joke De Gelder
joke.degelder@anacura.com

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API Development
Arcinova
Drug Substance : Small Molecules

Arcinova is a CRDO which operates from a 15,000m2 facility which has benefited from more than 36 years of investment as a key research and development centre for Sanofi and Covance. Arcinova serve the global pharmaceutical and biotechnology communities offering a range of services including drug product manufacture, formulation, bioanalytical and metabolism services, radiolabelling synthesis and synthesis of toxic/highly potent APIs, and can provide both integrated and standalone services.

Keywords: API Development, Biologics, Small molecules

Nathalie Huther
nathalie.huther@arcinova.co.uk

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Recent examples in outsourcing of microbial process development & manufacturing
Capua BioServices S.p.A.
Drug Substance : Biologics

Capua BioServices is a global provider of services for microbial custom development and manufacturing for the Pharma and Food industry. Microbial fermentation has its opportunities and challenges for biopharmaceutical manufacturing: from lab to pilot to commercial scale. In this poster, Capua BioServices would like to highlight recent successes from outsourcing of microbial projects.

Keywords: CDMO; microbial fermentation; enzymes, small molecules, outsourcing; biologics

Elise Mous
elise.mous@capuabioservices.com

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Isomeric Purity: Analysis, MG, KG & Production
Chiral Technologies Europe
Analytical : Small Molecules

Chiral Technologies Europe (CTE) is the global leader in enantioseletive chromatography. CTE provides products and services for resolution of racemic compounds. We offer the life science industries the largest portfolio of chiral stationary phases (CSPs); analytical and preparative chiral columns. These are used by pharmaceutical, biopharmaceutical, and agrochemical customers in High Performance Liquid Chromatography and Supercritical Fluid Chromatography to aid their discovery and development.

Keywords: chiral technologies, Chiral, separations, Method

Brian Freer, Ph. D
bfreer@chiral.fr

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AGE-RELATED HEARING LOSS MODEL
CILcare
Discovery : Other

SAMP8 mouse model presents accelerated senescence and has been identified as a model of gerontological research. We studied the effect of N-acetylcysteine (NAC), an antioxidant, on SAMP8 hearing loss and memory. We observed a strong decrease of auditory brainstem response thresholds and an increase of distortion product amplitudes in NAC treated group compared to vehicle. Results confirm that NAC delays the senescence process by slowing the age-related hearing loss and improving memory.

Keywords: Hearing loss, Aging, SAMP8, antioxidant, memory

Wahid Awad
wahid.awad@cilcare.com

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Crystallization and X-ray structure analysis of small molecules
Crystallise! AG
Analytical : Small Molecules

With a crystallization success rate higher than 90% Crystallise! has succeeded to crystallize and produce the molecular structure of compounds that other CROs couldn't crystallize. Some case studies are presented here, including a penta-peptide API which over a period of 4 years wasn't crystallized. A joint publication with Roche on a polymorphic API is showcased here too. Electron Diffraction (ED), a new analytical method to obtain the molecular structure of nano-powders is presented as well

Keywords: Crystallization, X-ray structure, synchrotron radiation, Electron Diffraction, small molecules

Gustavo Santiso-Quinones
info@crystallise.ch

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Characterisation of Materials from an Alternative Supplier for a Modified Release Capsule Drug Product
Custom Pharma Services
Analytical : Small Molecules

A new API supplier was identified for a modified release broad spectrum antibacterial capsule drug product. Samples from three separate batches of each material were provided for assessment. A series of both solid state and chemical tests were conducted in order to allow a comparison to be made, and determine whether the material from the new supplier would be suitable for routine use in commercial manufacturing.

Keywords: API, Characterisation, Solid State, Modified Release

Lisa Burns
Lisa.Burns@custompharma.co.uk

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Discovery : Small Molecules

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Keywords: els

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els@Gov.ma
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Discovery : Small Molecules

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Keywords: els

els
els@Gov.ma
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els
Discovery : Small Molecules

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Keywords: els

els
els@Gov.ma
QBD STRATEGY FOR LC METHOD DEVELOPMENT
Eurofins Amatsigroup
Analytical : Small Molecules

As part of Quality by Design (QbD) principle, new tools allow the pharmaceutical industry to develop more robust analytical methods from the earliest stages of drug development. With a QbD strategy, the method will be close to its optimum and more robust versus a 'traditional' approach. This strategy has been implemented at Eurofins Amatsigroup after several months of training and in- depth testing in order to use the software in an expert mode.

Keywords:

Nicolas Leroy
sales@amatsigroup.com

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Platform based strategies that deliver reliable and high quality continuous biomanufacturing processes
FUJIFILM Diosynth Biotechnologies
Business Process : Biologics

The challenge during mammalian cell line and upstream process development is to identify and isolate stable, high expressing cell lines producing product with the appropriate critical product quality attributes rapidly, reproducibly and with relative ease. Current platform processes are based on a defined set of hierarchical screening strategies utilised to identify key cellular performance criteria required for fed-batch culture.

Keywords: Upstream process intensification; cell line development; CHO; perfusion; microbioreactor; directed evolution

Emily Longstaff
emily.longstaff@fujifilm.com

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Complex Chemistry, Simply Delivered: Cocrystals Design, Development and Scale-Up
Johnson Matthey
Analytical : Small Molecules

Pharmaceutical compounds frequently encounter problems during development. Salt formation is one widely used approach to improve such properties, however cocrystals, using non-ionic interactions, offer an alternative route.

Keywords: cocrystals, solid form, solubility, dissolution rate, stability, melting point, hygroscopicity, crystallinity

William McFarlane
William.McFarlane@matthey.com

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Drug Discovery Services
Jubilant Biosys ltd
Drug Substance : Small Molecules

Jubilant Biosys and Jubilant Chemsys is a part of the drug discovery solutions (DDS) arm of Jubilant Life Sciences and has global reach providing comprehensive drug discovery services - from target to clinical candidate in partnership with leading pharmaceutical and biotech companies worldwide. Jubilant offers integrated discovery services spanning across Target Validation (TV) to Lead Optimization (LO) to Clinical candidate (CC)/IND submission, for multiple therapeutic areas. With its end-to-end services upto IND and one stop destination approach, the clients can focus more on the science than scattering the focus on to more than one CRO to manage the program. With well enabled disease biology & pharmacology expertise in Oncology, Metabolic Disorders, CNS, Pain and Inflammation Jubilant Biosys has emerged as a leading collaborator for biotechnology and pharmaceutical companies worldwide.

Keywords: Drug Discovery Services

Mr. Subir Dubey
Subir.dubey@jubilantbiosys.com

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Predicting solid dispersion stability using multiple linear regression models
Juniper Pharma Services
Drug Product : Small Molecules

The aim of this study was to produce a support tool for the formulation development of solid dispersions. A predictive statistical model was built using experimentally obtained stability data and the physiochemical properties of the APIs used. The model is intended to provide an indication of which polymer and manufacturing method is most likely to give a stable solid dispersion for a new drug.

Keywords: Drug solubility, stability, drug development, linear model, solid dispersion

Gudrun Fridgeirsdottir
gfridgeirsdottir@juniperpharma.com

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A cutting-edge improvement for biologics manufacturing
Mycenax Biotech Inc.
Drug Substance : Biologics

Mycenax Biotech Inc. (MBI) equips with CMC based platform, disposable technology, and PIC/S GMP manufacturing system, we dedicate to deliver satisfactory results by providing a high quality, cost-competitive and full line solution to manufacture biological products. Aiming to provide better services to our clients, we keep upgrading our technical capacity to meet the world manufacturing trend. Two highlights on recent MBI technology platforms are MBI JUMP and Mycenax Continuous Processing.

Keywords: MBI JUMP,Continuous Processing

Sunny Wang
sunny.wang@mycenax.tw

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BIOCATALYSIS FOR PHARMACEUTICAL SYNTHESIS
PCAS Protéus
Drug Substance : Small Molecules

Protéus is a biotechnology company specializing in the discovery, engineering and production of enzymes for industrial applications, as well as in the development of innovative bioprocesses involving these enzymes. Protéus is a subsidiary of the PCAS Group, actor in fine chemicals and specialty products and producer of high-value complex molecules. Enzymes allow considering unique functionalizations that are difficult to achieve by conventional chemical means.

Keywords:

Audrey ROBIC
arobic@proteus.fr

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Host Cell Protein analysis with Mass Spectrometry - The power of impurity identification
Protagen Protein Services GmbH
Analytical : Biologics

Developing and producing recombinant biopharmaceuticals in mammalian cells requires unambiguous monitoring of HCPs impurities. Immunoassays are still the method of choice for release testing, however, peptide analysis by MS has been proven to be a powerful tool box by providing complementary data for HCP characterization. We show that MS supports the data interpretation of methods for antisera characterization, like high resolution 2D PAGE/ Immunoblotting to demonstrate antisera coverage.

Keywords: Host Cell Proteins, Process Related Impurities

Dr. Marcus Mreyen
marcus.mreyen@protagenproteinservices.com

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Recipharm Pathway to Clinic©
Recipharm
Drug Product : Small Molecules

A Swedish biotechnology company called Betagenon was ready to take its new drug candidate O304 to clinical trials. The molecule is an AMP-activated protein kinase (AMPK) activator for the treatment of chronic energy balance disorders in metabolically challenged elderly and/or obese individuals. Clinical Trial Consultants (CTC) and Recipharm were selected to perform the work needed to reach the customer's important phase I milestone.

Keywords: BE-studies, PK-studies, Early clinical studies

Evelina Videll
evelina.videll@recipharm.com

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Application and advantages of hazardous chemistry in API development and manufacturing
Sterling Pharma Solutions
Drug Substance : Small Molecules

Sterling offers Hazard Evaluation, on-site Chemistry and Process Engineering twinned with the capability to understand and handle hazardous processes and materials safely under cGMP. Most substances and chemical reactions have the potential to exhibit a degree of energetic or hazardous behaviour. The ability to understand this behaviour, accommodate these materials and processes and exploit their benefits is a key advantage in API synthesis.

Keywords: hazardous chemistry, hazard evaluation, API development, API manufacturing, highly potent API

Andrew Henderson
Andrew.Henderson@sterlingpsl.com

Sunshine Guojian Pharmaceutical (Shanghai) Co Ltd
Analytical : Biologics

Sunshine Guojian Pharma is an emerging global player in contract development and manufacturing organisation (CDMO) industry, focusing on mAb biopharmaceuticals. We offer our clients an integrated and highly customer-oriented range of contract services from preclinical development to commercial manufacturing. Leveraging our technical expertise and rich experiences from more than a decade of a successful track record.

Keywords: Biological facility

Anna Dong
anna.dong@gj.3sbio.com

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A journey of CRO with a virtual Pharma company
Syngene International Limited
Discovery : Small Molecules

Discovery Chemistry activities performed for a virtual pharma company includes the MedChem, impurity identification and synthesis of metabolites, degradants, reference standards and route scouting for the clinical trial compound. A case study based on protecting group free synthesis to identify the novel synthesis route to improve the yield, reduce the number of steps and to avoid a hazardous intermediate.

Keywords: Discovery Chemistry, MedChem, Route scouting, small molecule service provider, CRO, Syngene, impurity synthesis, synthesis

Jeyaprakashnarayanan Seenisamy
jeya.prakash@syngeneintl.com

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LC-MS/MS Assessment of monoclonal antibody stability -Monitoring Tryptophan and Methionine oxidation
Syngene International Limited
Analytical : Biologics

A method was developed to accurately identify site-specific oxidation using state-of-the-art LC-MS/MS

Keywords:

Ravi Krovidi
Ravi.Krovidi@syngeneintl.com

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Archived Posters for: 2017 |