Newsletter | October 6, 2020

10.06.20 -- IONTAS And FairJourney Biologics Discover SARS-CoV2 Neutralizing Antibodies

Industry Insights
Debunking Myths And Misconceptions About Softgels

Softgels are a popular dosage form among consumers because of their easy swallowability and quick onset of action. Pharmaceutical developers often don’t consider softgels to be the best choice for prescription drug formulations, however, instead favoring tablets and hard-shell capsules. Here, we take a look at some common myths about softgels and explore why drug developers may want to reconsider their go-to delivery methods.

Organs On Chips: Solving Persistent Pharmacokinetic Problems

For many years, a rather insistent, expensive problem has been plaguing pharmacology — it’s quite tricky to understand the pharmacokinetics of new drugs without giving them to someone. Organs-on-chips, the specialty of Dr. Dan Tagle at the NIH, could be the answer.

Addressing The Complexity Of Process Validation For Cell And Gene Therapy Products

The expectation ― just as it is with biologics ― is that the process is the product. However, cell and gene therapy products have unique features that must be considered during process validation.

Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product

Thermo Fisher’s stepwise approach to Quality by Design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

Raw Material Variability: The Need For Deeper Process Understanding

Principles and methods for biopharma development and manufacturing are well established, but increased molecular diversity and a drive for higher productivity brings new challenges to process developers.

The Criticality Of API CDMO Selection: Insights From A Client

Small and emerging companies face challenges related to limited funding and resources, such as technical expertise and capacity, making it imperative they find a competent partner to support them.

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.

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