Newsletter | May 20, 2019

05.20.19 -- A Technology Roadmap For Today's Gene Therapy Manufacturing Challenges

Featured Editorial
A Technology Roadmap For Today’s Gene Therapy Manufacturing Challenges
By R. Carbonell, A. Mukherjee, J. Dordick, and C. Roberts

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has published technology roadmaps addressing needs and gaps in three key product areas: gene therapy, antibody-drug conjugates, and vaccines. The roadmaps were developed with the collaborative input of industry, academic, and government experts. 

Incorporating Natural Hazards And Distributed Infrastructure Into Risk Management For Biopharma Operations
By Mark Vessely, BGC Engineering, Inc., and Christina Vessely, Biologics Consulting, Inc.

Natural hazard events may seem like distant topics to some in the biopharmaceutical industry, but they hold relevance for all companies. Opportunities exist for risk management, including an important lesson in avoiding the gradual acceptance of such events as normal, until an even greater catastrophic event occurs.

Industry Insights
Microbiology Fills QC Role At A CDMO In Aseptic Filling And Sampling
Article | By Summer Wade, Singota Solutions

Microbiological contamination is at the top of the CDMO threat list. A CDMO needs to have clearly defined procedures and allow clients access to data.

Amgen’s Digital Transformation: Link Suppliers' Raw Material Data To Patients
Article | By Cenk Undey, Amgen, GE Healthcare Life Sciences

Using its Supplier Relationship Excellence program, Amgen opened the lines of communication with suppliers and created a feedback loop where data can be shared to optimize operational performance. 

Upstream Bioprocessing In Food And Feed Applications
White Paper | By Ulrike Rasche, Eppendorf

Bioprocessing has been used for decades for the industrial production of beverages and for the production and preservation of food and feed ingredients. 

Extractables And Leachables Studies Support Single-Use Systems
Case Study | By Aryo Nikopour, Nitto Avecia Pharma Services

Concerns about leachables were expected to restrict adoption of single-use systems. This case study shows how far they’ve come.

Millennium's ELN Empowers Chemists And Biologists
Case Study | Dassault Systemes Americas

Biotech Millennium found that by clearly defining workflows and implementing a highly configurable notebook, it could move its entire discovery organization to a single ELN system.

Principles On Which The Limulus Test For The Detection Of Bacterial Endotoxins Is Based
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.

The Use Of Amsphere A3 Resin To Purify Antibody Fragments
Q&A | JSR Life Sciences

This Q&A outlines the use of Amsphere A3 resin to purify antibody fragments, explains the molecular binding mechanism for VHH single-domain antibodies, and compares dynamic binding capacity data with those of other affinity resins.

Drug Development: Strategies And Solutions
Thermo Fisher Scientific
Life Science Leader Magazine

Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.

Connect With BioProcess Online: