Newsletter | February 12, 2020

02.12.20 -- Valentine's Day Heartbreak: How To Let Your (Underperforming) CMO Partner Go

  Discuss Downstream Purification Strategies At 2020 Events
  • BPI Asia, February 26 to 28, Kyoto, Japan. Attend the Poster Session on Nuvia aPrime 4A and request resin samples
  • BPI West, March 9 to 12, Santa Clara Convention Center. Visit Booth 506 and attend the Boehringer Ingelheim Site Tour and Process Development Seminar on March 9
  • ACS BIOT, March 22 to 26, Philadelphia, PA. Attend the Protein Purification Lunch Seminar on Tuesday, March 24 at 12 to 1:30 PM and the Poster Session at 6 to 8 PM
  • Bioprocessing Summit Europe, March 24 to 26, Barcelona. Discuss mixed-mode purification case studies during the Poster Hall Session
Featured Editorial
Valentine’s Day Heartbreak: How To Let Go Of An Underperforming CMO
By Herman F. Bozenhardt and Erich H. Bozenhardt

What should you do if your CMO has a deteriorating plant that directly impacts your production, or personnel turnover that creates an environment of never-ending deviations and senseless retraining? Here's how to determine when to cut the cord and exit a relationship to save your product or company — and how to do it systematically.

Recommendations For Managing Complexity In Biopharma Operations
By Jim Morris, NSF Health Sciences Pharma Biotech

There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.

Industry Insights
How To Boost Profits With Single-Use Powder Transfer In Biopharma
Article | By Chris Rombach, ILC Dover

Does your powder system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?

Is Your Sterile Injectable Ready For Changes In Raw Materials?
Article | By Lisa Cherry, Ph.D., Pfizer CentreOne Contract Manufacturing

Over the life of a drug changes in raw materials are inevitable. But even a small modification can throw your drug out of compliance. Learn how to safeguard drug integrity when raw materials change.

Top 5 Events That Can Impact Your Clinical Supply Chain
Article | By Sylvia Tsengouras, Thermo Fisher Scientific

Review practical solutions for “small changes” in the clinical supply chain that can wreak havoc if not planned for in advance.

Using A CMO To Streamline Process Characterization
White Paper | By Evan Pasenello and Daniel Sayut, AbbVie

While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

CMC Strategies For A Bispecific Antibody Platform For Cancer Immunotherapy
White Paper | By Jianzhong Hu, YZY biopharma

Bispecific antibody development presents many challenges in product expression, bispecific purification, product stability, and scale up of the manufacturing process. 

Freezing And Thawing Of Protein Solution
White Paper | Single Use Support

Parts of a protein solution will show less activity based on the stress it's exposed to during freezing and thawing. It's important to optimize the freezing and thawing process to minimize activity loss.

Single-Use Systems For Storing And Shipping Frozen Drug Materials
Article | CPC

The logistics of decoupling drug substance manufacturing from final drug product formulation is now possible using integrated single-use freeze-thaw assemblies that incorporate reliable components.

Are The Components In Your Prefilled Syringes Compatible?
Article | Parenteral Drug Association (PDA)

While a prefilled syringe offers many advantages for biologics products, manufacturers must evaluate the potential impact of a prefilled syringe on product quality prior to selecting the final components.

Quality By Design Approach To Analytical Method Optimization
Case Study | Catalent

A quality by design (QbD) approach solved a high-performance liquid chromatography analytical method problem where impurity peaks had shifting retention times making identification and quantitation problematic.

Preferred Provider Use Among Small Molecule Outsourcers
Infographic | ISR Reports

In Q4 2018 ISR asked 134 outsourcers of small molecule drug substances and 136 outsourcers of small molecule drug products about their organization’s use of preferred providers.

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