BioPharm International, April 2022 Issue

The need to increase efficiency and productivity is driving adoption.

The recent success of mRNA vaccines has opened the door for further and future development of nucleic acid-based therapies.

The growing demand for antibody and other bio-therapeutics will require long-term scale-up solutions.

The past year of downstream processing has brought innovations in pH sensitive antibody purification, single-use fermentation separators, and more.

Data may be used to improve (or remove) a corrective action/preventive action.

Taking key considerations into account along the cell therapy supply chain can set cell therapy developers up for success.

As process controls adjust to a continuously shifting manufacturing landscape, implementation of information gathered from novel data analysis techniques has become a priority.

The booming cell therapy market has created a need for capacity that outsourcing partners are ready to fill.

Effective cleaning and disinfection along with contamination controls are imperative when operating and utilizing a cleanroom.

BioPharm International spoke with Colleen Floreck, vice president, Global Marketing and Strategy, Catalent Cell and Gene Therapy about the specific requirements and challenges for expanding production of viral vectors.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. BioPharm International asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.

3D cell cultures could provide key avenues to unlocking critical information.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, discuss the verification of compendial methods.

Advances in pharmaceutical neuroscience present an opportunity for pharmaceutical companies to stay ahead of the curve.