Newsletter | September 16, 2020

09.16.20 -- Global Regulatory, Quality Environment For Biopharma Outsourcing

Featured Editorial
Industry Insights
Is Your Biologics At Risk For Protein Aggregation? Part 2

How to prevent protein aggregation via considerations for the manufacturing process and container selection criteria. Part two of a three-part series.

How Supplier Evaluations, Component Neutrality Enhance Supply Chains

When a new product, technology, or supplier is selected during the development and design phase of the biological manufacturing process, manufacturers must assess the supplier’s own supply chain and beyond.

The Value Of Expertise In Aseptic Fill/Finish Manufacturing Of Biologics

Aseptic fill/finish manufacturing is one of the final, but crucial, steps between biopharmaceutical development and patient care, and it's especially critical for highly valuable biologics drug substances.

Quality Assurance And Your CDMO

The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

Analytical Quality By Design Using Design Of Experiments

This poster demonstrates how a panel of analytical assays designed for a mAb used different design of experiment (DoE) approaches for rigorous statistical design and analyses for assay development.

Challenges, Risks, And Strategies For Biologics Substance Manufacturing

From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologics drug substance production.

How Can You Reduce Timelines From Gene To IND Without Increased Risk?

Moving too quickly can open your drug development program up to many risks, making it critical to achieve the optimal program profile for a seamless transition from gene to IND and beyond.

How Buffer pH And NaCl Affect Size Exclusion Chromatography

Using a design of experiments approach, this study describes the effect of buffer pH and NaCl concentration on proteins purified by size exclusion chromatography.

The Challenges Of Biopharmaceutical Quality

More than ever, the quality functions in biopharma manufacturing are under pressure. That pressure is unlikely to be relieved any time soon due to a global market rife with complex quality standards.

Save Space With Single-Use Bags, Secondary Packaging Solution

Find out how a multinational biopharma company overcame a diminished shipping capacity challenge after switching to single-use bags to improve storage capacity at one of its production sites.

Capture OTC Market Share For Geriatric And Pediatric Patients

This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations. 

pDADMAC Flocculation And Clarification: Development To Implementation

This webinar serves as an overview of key aspects associated with pDADMAC flocculation implementation, including data for cleanability of stainless-steel surfaces soiled with pDADMAC flocculated cell culture.

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