Newsletter | October 7, 2019

10.07.19 -- Abcentra Chief Looks Beyond The Clinical Horizon


Formulation and tech transfer present perennial challenges for biopharma. That's why they're focal points at Catalent. Learn how we're leveraging state-of-the-art automation technologies to enable high-throughput formulation development and how we are applying innovative approaches to process management to address equipment and materials challenges during tech transfer.

Featured Editorial
Abcentra Chief Looks Beyond The Clinical Horizon
By Matthew Pillar, chief editor, BioProcess Online

Why Bert Liang, M.D., Ph.D., and CEO at clinical-stage biopharma company Abcentra, obsesses over at-scale manufacturing and regulatory challenges from the outset of his company's clinical trials. 

5 Barriers To Blockchain Adoption In The Biopharma Supply Chain — And How To Overcome Them
By Mark Karhoff, Ten Count Consulting, LLC

Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. While some of the largest biopharma companies in the world are now conducting pilots, several remaining obstacles must be overcome.

Industry Insights
Early Product Characterization Mitigates Risks In Biologics Development
White Paper | By Daniel Galbraith, Ph.D., MilliporeSigma (Product Characterization)

The relationship between the basic physicochemical profile and biological activity — and how this relationship affects clinical performance — is a key component of making informed decisions, accelerating development, and reducing risk throughout the product life cycle.

Full Single-Use Downstream Process? Not Any Time Soon
Article | By Madhu Raghunathan, GE Healthcare Life Sciences

Single-use technologies (SUTs) are here to stay. But where we see full single-use upstream processes, downstream is often a hybrid solution. Here’s why SUTs will not completely replace reuse systems in the near future.

Five Questions On Extractables And Leachables In Clinical Development
Q&A | By Aryo A. Nikopour, Nitto Avecia Pharma Services

Extractables and leachables (E&Ls) safety assessments are among the most challenging review issues in an FDA application because they require a coordinated effort among chemistry, manufacturing, controls, and toxicology review staffs. Here's guidance on five common questions.

Implementation Of Single-Use In Drug Substance Filling Before Transportation
Case Study | By Guy Matthews, Parker Bioscience Filtration

This article discusses the product development cycle of a system for bulk filtration of active pharmaceutical ingredients (APIs), how this development progressed from generation one to two, and the lessons learned along the way.

Principles On The Limulus Test For The Detection Of Bacterial Endotoxins
Article | FUJIFILM Wako Chemicals U.S.A. Corp.

The LAL or Limulus test is used for the determination of bacterial endotoxins in a wide variety of samples. In this article, the biological process and the way it was used to develop the test is described.

5 Steps To Accelerated Biologics Manufacturing And Robust Scale-Up
White Paper | AbbVie

Establishing a platform approach to process characterization ensures the entire process is robust, right the first time, and results in a highly consistent product to facilitate efficient BLA filing. This five-step process accelerates time to a robust and reliable commercial-scale process.

Direct-To-Representative Sample Distribution Services
Case Study | Thermo Fisher Scientific

Pharmaceutical manufacturers use a range of marketing channels to promote their prescription drug product. One proven and particularly effective approach is to have pharmaceutical sales representatives hand carry samples to the health care practitioners within their territories.

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Lonza Pharma & Biotech
CPC AseptiQuik S Best Practices
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