Newsletter | March 25, 2020

03.25.20 -- Business Continuity & Coronavirus: Are Pharma Operations At Risk?

  Optimizing Cell Culture Media To Increase Titer And Maintain Protein Quality

When evaluating media with the goal of increasing titers, it is important to ensure that protein quality is not negatively impacted. So how can this process improvement be performed reliably? It makes sense to use a design of experiment (DoE) and empirical approach. Here is an example of how to do it.

Featured Editorial
Business Continuity & The Coronavirus: Are Your Pharma Operations At Risk?
By Bikash Chatterjee, chief operating and science officer, Pharmatech Associates

In the face of a pandemic, the value of a robust business continuity plan cannot be overstated. Organizations should actively evaluate those plans, focusing on service providers and partners. 

An Introduction To Agile Project Management For Pharmaceutical Outsourcing
By Hector M. Samper and Wolfram Mueller

In part 1 of a three-part series, we explore why modern sponsor-CDMO partnerships must be agile and flexible, bringing together professionals from multiple disciplines to find solutions that increase efficiency. 

Industry Insights
Prepared For The Biopharma Market's Diverse Manufacturing Needs?
Article | By Tristan Wilkins and Jeffrey Robinson, Lonza Pharma & Biotech

Meeting the needs of the modern biomanufacturing landscape requires a combination of technology and digital solutions working together to effectively and efficiently meet your goals.

The Upstream/Downstream Process Balancing Act
Article | By Serena Fries Smith and Hunter Malanson, Thermo Fisher Scientific

Early collaboration and open communication between upstream and downstream are crucial to ensure a consistent end-to-end bioprocess.

Are "Do-Overs" Practical In Biopharmaceutical Manufacturing?
Article | By Josh Eaton, Parenteral Drug Association (PDA)

What should a manufacturer do when an API or intermediate from a biopharma manufacturing process does not meet specification, or when a process has operated outside the validated operating range? 

Cell-Based Potency Assay In Functional Characterization Of Therapeutic mAbs
White Paper | By Agata Burzawa and Pamela Hamill, Ph.D., MilliporeSigma

Because characterization and comparison of originator and biosimilar candidate monoclonal antibodies (mAbs) is challenging due to their complex and variable structures, a range of analytical techniques should be employed.

Host Cell Protein Clearance By Amsphere A3 And Other Protein A Resins
Poster | By S. Tsuda, T. Tanaka, et al., JSR Life Sciences

Clearance of host cell proteins (HCPs) is one of the performance parameters of downstream antibody production. In this poster, results for Amsphere A3 were compared with two other commercially available resins.

Recirculation Flow Testing A Biocontainer
Application Note | Meissner Filtration Products

A common challenge of using rocker bioreactors in perfusion mode is the transfer of air into the recirculation pathway. Here, a new anchored dip tube designed to prevent the problem is evaluated.

Approach To Simplifying Aseptic Contract Manufacturing
Article | Singota Solutions

This article addresses some of the challenges and solutions available to pharma/biotech companies and their supply chain partners to ensure critical clinical supply materials are ready when needed.

Are You Prepared For The Complexity Of Pediatric Drug Development?
Article | Thermo Fisher Scientific

Pediatric drug development requires a formulation designed to fit the specific needs of that patient population. Not considering these requirements early enough could add significant delays.

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

The LAL (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.

Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up
White Paper | GE Healthcare Life Sciences

In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale-up.

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

A platform approach to process characterization ensures accuracy and results in a consistent product, which facilitates efficient BLA filing and acceleration to commercial scale.

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