Newsletter | November 6, 2019

11.06.19 -- Outsourcing Insights From A Tech Transfer Veteran

Featured Editorial
Outsourcing Insights From A Tech Transfer Veteran
By Matthew Pillar, editor, BioProcess Online

Explore tech transfer expert Anthony Grenier's opinions on the most common mistakes he sees, how to avoid them, and planning ahead to beat the CMO capacity crunch.

ISO 22519: An Unnecessary, Faulty, And Confusing Standard

The ISO Standard 22519 claims to be the new word in purified water (PW) compliance. In fact, the standard neither promotes innovation nor compliance. On the contrary, it brings confusion to those that are embarking on purified water production and use in the pharmaceutical industry.

Industry Insights
A New Process For Reducing Glass Breakage
Article | By Mads Reedtz Espersen, Novo Nordisk

Glass breakage is commonly acknowledged as a major nuisance in parenteral manufacturing. It causes a plethora of problems, such as disruption of production, particle contamination, and loss of sterility.

Is Your Quality Agreement Fit-For-Purpose?
Article | By Melanie Ziehm, AbbVie

Choosing to partner with a trusted CDMO for drug development and manufacture requires an established quality policy. That policy should address management responsibilities, risk management, documentation, change management, CAPA, process performance, and product quality. 

Avoid The Fallout From Incompatibility Between Your API And Its Formulation
Article | By Matthew Jones, Thermo Fisher Scientific

It is critical the experts creating a drug product’s formulation are aware of any reactions that can occur between an API and a tablet’s excipients.

Demystifying Extractables Testing
White Paper | By Graeme Proctor, Parker Bioscience Filtration and Nick Morley, Hall Analytical

It is critical anyone utilizing single-use technology understands the differences between the various guidances available for extractables analysis and which testing approaches are most suited to the study goals.

Effective Downstream Purification For A Clinical-Stage Retrovirus-Like Particle
Case Study | By Mark Fitchmun, Bio-Rad Laboratories, Inc.

Purification of enveloped viruses and virus-like particles presents several challenges due to their large size and complexity. This case study demonstrates resin screening, process development, and scale-up purification of a retrovirus-like particle. 

Redox Potential Monitoring For Improved Anaerobic Fermentation
Application Note | By Ying Yang and Ma Sha, Eppendorf

Understand the suitability of the BioFlo 120 control station equipped with BioBLU 3f Single-Use Vessels for anaerobic fermentation.

Flow And Gradient Accuracy Are Key To Scale-Up And Speed-To-Market
Application Note | GE Healthcare Life Sciences

Accurate flow is important in chromatography. In this application note flow accuracy was investigated at a combination of different backpressures, flow rates, temperatures, and liquid viscosities.

Process Impurities: Don’t Let PEI Or HCP Derail Your Biotherapy
Webinar | MilliporeSigma (Product Characterization)

This presentation addresses product characterization strategies to de-risk the manufacturing of mAbs and cell and gene therapies. It also covers detection and characterization of host cell proteins (a factor in mAb therapies and cell and gene therapies) and polyethylenimine, which is used in cell and gene therapies.

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