Newsletter | November 27, 2019

11.27.19 -- Early-Stage Biopharma Funding Advice From A Leading VC

Featured Editorial
Early-Stage Biopharma Funding Advice From A Leading VC
By Matthew Pillar, editor, BioProcess Online

5AM Ventures senior associate Jason Ruth, Ph.D., dished some insider advice to biotech fund seekers in the Pittsburgh LifeX Labs community, and BioProcess Online was there to catch his talk. Here are the highlights.

Will Authorized Biologics Disrupt The Market For Biosimilars?
By Ha Kung Wong and Erica L. Norey, Venable Fitzpatrick

The small molecule generic drug market and the current biologics/biosimilar market are ultimately not directly comparable. However, it's instructive to analyze how authorized generics impact the small molecule space to predict how authorized biologics may impact the biosimilar/interchangeable market in the future.

Industry Insights
Balancing Stainless, Single-Use, And Continuous Manufacturing
Article | By Madhu Raghunathan, GE Healthcare Life Sciences

Several drivers affect how the appropriate facility design and unit operations for a process are selected, making it imperative to properly evaluate each option. 

7 Key Areas Of Risk In Single-Use Bioprocessing: Is Your Process Protected?
Article | By Andrew Kelly and Graeme Proctor, Parker Bioscience Filtration

Is your bioprocess adequately protected against the risks associated with single-use technology? Discover the seven key areas of risk in single-use and learn the strategies to protect against each risk.

Manufacturing: CDMOs, Blockchain, And Distributed Ledger Technology
White Paper | By Wayne Woodard, Jeremy Macedo, and James Gilmore, Argonaut Manufacturing Services

CDMOs and pharmaceutical developers could realize tangible benefits by implementing distributed ledger technology (DLT), which promises better transparency within the pharma supply chain. We'll cover the integration, cost, governance, and accountability challenges DLT presents here. 

Extractables And Leachables: A Review Of Guidance From The Industry
Webinar | By Aryo A. Nikopour, Nitto Avecia Pharma Services

Appropriating BPOG testing on single-use connectors to mitigate the risks of extractables and leachables (E&L), as demonstrated in this article, is crucial to delivering safe and effective drugs.

Flow Chemistry vs. Batch Processes
White Paper | GVK Biosciences

Traditionally, new chemicals are developed using batch processing, which fully relies on versatile and qualified equipment to perform different unit operations. To address challenges, continuous flow chemistry technology is emerging as an effective tool to conduct chemical synthesis.

Can You Afford Not To Outsource Buffer Preparation?
White Paper | Thermo Fisher Scientific

The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.

Extractables Testing On Single-Use Connectors
White Paper | CPC

Appropriating BPOG testing on single-use connectors to mitigate the risks of E&L, as demonstrated in this article, is crucial to delivering safe and effective drugs.

Standardizing Process Characterization And Late-Phase Development
Case Study | Catalent

Process characterization is an important step in the overall journey of product development. This case study proposes an approach for process characterization for the production of a monoclonal antibody, specifically at the drug substance biomanufacturing step.

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