Newsletter | June 5, 2019

06.05.19 -- Gene Therapy: Commercial Challenges And Strategic Choices

Featured Editorial
Gene Therapy: Commercial Challenges And Strategic Choices
By Ricardo Brau and Pierre Jacquet, L.E.K. Consulting

Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.

Mystery And Danger: Flammables And Oxidizers In Pharma Filling Operations
By Erich H. Bozenhardt and Herman F. Bozenhardt

Benzyl peroxide (BPO), a compound that has both a fuel source and oxygen (two legs of the fire triangle) built into it, can make handling of a purified version of this compound very interesting.

Industry Insights
6 Regulatory Changes Affecting Bioprocessing In China
White Paper | By Scott M. Wheelwright, Complya Asia

This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.

How To Design Cell-Based Potency Assays
Article | By Aryo Nikopour and Ming Li, Ph.D., Nitto Avecia Pharma Services

Not seen on HGTV: method design for cell assays. The many decisions when designing cell-based potency assays make home remodeling look easy.

Volume Reduction And Process Optimization With Inline Concentrator
Application Note | By Catherine Casey, M.Sc., and Engin Ayturk, Ph.D., Pall Biotech

See how this solution not only provides additional capital savings but will also resolve potential manufacturing floor space limitations.

Vero Perfusion, Packed-Bed Vessels Intensify Vaccine Production
Application Note | By Xiaofeng (Kevin) Han, Ph.D., Ulrike Becken, Dr.rer.nat., and Ma Sha, Ph.D., Eppendorf

Read how the Eppendorf BioBLU 5p single-use vessel prepacked with Fibra-Cel disks is an excellent platform for high-density Vero cell culture.

Mycoplasma Contamination: Understand The Risks, Take On The Challenges
Q&A | By Guy Matthews and Dr Carolyn Heslop, Parker Bioscience

Mycoplasma contamination events, although rare, can have an enormous and immediate negative impact on biomanufacturers, leading to reduced productivity and delays in products reaching patients. 

Inaccurate Forecasting Is Here To Stay: Focus On Managing Risk Instead
Article | Thermo Fisher Scientific

It’s no secret that drug forecasts are notoriously incorrect, and often by large margins. With no signs of improvement in forecasting accuracy, how do companies minimize risk?

Enhanced Assurance Of Quality Supply For Single-Use Predesigned Solutions
White Paper | Sartorius Stedim Biotech

Read how resin specifications, process qualification, and process controls established at all stages of the manufacturing process can ensure quality, change control, and business continuity.

Small Molecule Impurities Represent A Key Challenge When Designing Control Systems For ADC Therapeutic Manufacture
White Paper | AbbVie

Composed of both antibody and small molecule elements, antibody-drug conjugates (ADCs) have a complex structure from which many different impurities can arise. Drawing on existing ICH guidelines, a recent publication coauthored by AbbVie suggests a science-based approach that can be applied to the design of an effective control strategy for small molecule impurities in ADC therapeutics.

Contract Development And Manufacturing Solutions For Recombinant Proteins
Grifols Recombinant Protein CDMO Services
Personalized Healthcare Is Better Healthcare
Dassault Systemes Americas
Nuvia aPrime 4A Hydrophobic Anion Exchange Resin
Bio-Rad Laboratories, Inc.
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