Newsletter | November 5, 2019

11.05.19 -- Empowering Drug Discovery By Evaluating Antivirals In Thousands Of Single Cells


The BioProcessing Asia Conference was created to advance the contribution of bioprocessing sciences, products and medical interventions to the region. This e-book provides an illustration of the cutting-edge presentations, from the sustainability of biosimilars, to the regulatory climate in Asia, the challenges facing the international bioprocessing community and the latest technologies for viral vector/ vaccine production. Some of the articles you’ll find within the e-Book are:

Download the full e-book here: BioProcessing Asia Conference In Review

Industry Insights
Managing Refrigerated vs. Frozen Drug Product: What’s The Big Deal?
Article | By Bruce C. Simpson, Thermo Fisher Scientific

The most common storage is ultra-low temperature storage, but the fastest-growing is cryogenic, in vapor phase liquid nitrogen. This transition is huge. Chain of temperature data and chain of custody in handling is imperative to the pharmaceutical industry of today.  These additional factors partly explain the much higher cost of these therapies as well. The three primary issues are: capacity, regulatory, and risk. We’ll look briefly at all three.

Converting From ELISA To Biacore SPR Assays
Application Note | GE Healthcare Life Sciences

Biacore SPR assays provide an automated and reproducible real-time determination of active concentrations that can be considered an alternative to traditional ELISA approach. This article provides general guidance on how to convert an existing ELISA assay to a Biacore SPR-assay and by doing so, shows how you can get results in less than half the time compared with ELISA.

Developability Assessment Of Small Molecules
White Paper | GVK Biosciences

Developability assessment or preformulation studies of small molecule is an important part of drug discovery process leading to selection of New Chemical Entities (NCEs) for clinical studies. This white paper dives deeper into why we need developability assessment as well as its processes.

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CRO Oversight Post ICH GCP E6 (R2) Addendum


Writing Effective 483 And Warning Letter Responses


Implementing A Robust Change Control Program – Key Elements For Process And Documentation Compliance
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21 CFR Part 11: Understanding The ERES Regulation For Compliance Success
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Essentials Of Disinfectant Efficacy Testing – Ensuring Microbial Control
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Establishing Appropriate Quality Metrics
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