Newsletter | November 23, 2022

11.23.22 -- Frequent Deficiencies In GMP Inspections, Part 1

Featured Editorial
Industry Insights
Quantify And Characterize Host Cell Proteins With Confidence

Robust solutions deliver accurate results to prevent HCP underestimation and maintain the pace of biopharmaceuticals development and production.

The Chemistry Of Bacterial Endotoxins: Toxicity And Immunogenicity

The diseases related to Gram-negative bacteria affect humans and animals and, in many cases, are difficult to treat, which is why it's important to have effective and bacteria-specific antibiotics.

Maintain Suspension HEK 293 Cells

HEK 293 cells require proper care for optimal performance in your next experiment, whether it be for basic science research or for production of biotherapeutics.

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

Is Your Sterile Injectable Ready For Changes In Raw Materials?

Changes in raw materials are inevitable over a drug's lifespan, but even small modifications can throw your drug out of compliance. Learn how to safeguard drug integrity when raw materials change.

Outsourcing Microbial Fermentation To A CMO: Key Considerations

Advances in synthetic biology and genetic engineering have fueled the potential of fermentation-based manufacturing. Here we examine key trends and challenges to the approach.

Comparator Local Sourcing Strategies: Avoiding Pitfalls For Clinical Trials

The growing demand for comparators is causing many supply chain managers to explore available sourcing options. Explore alternative local sourcing strategies, including advantages and disadvantages.

Developing Cost-Effective, Accelerated Downstream Processes

Read about the development of affinity chromatography products that compress the downstream process and reduce the inefficiencies of nonaffinity chromatography.

Transition To Closed Processing Systems

Learn about our transition to closed processes for the expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.

Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help.

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