Development

Articles

In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.

Celsion and Poly Pharm to Manufacture Celsion’s DNA-Based Vaccine

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

Moderna and ILCM Announce Collaboration to Develop mRNA Therapeutic for CN-1

Jennifer Markarian is manufacturing editor of BioPharm International.

Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.

Using Digital Twins to Model Process Chromatography

Models of biopharmaceutical processes can be used for speeding development and improving process control. 

Opportunities for Digital Twins

Scientific advances open the way to alternatives to animal testing and in-vivo assays.

In Vitro Pulls Ahead of In Vivo for Adventitious Agent Testing

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

The benefits of single-use technologies for upstream viral-vector processes clearly outweigh their disadvantages. 

Single-Use Technologies Prove Effective for Viral Vector Process Development

The collaboration continues as the companies design bioprocess impurity reagent sets to detect residual HCP from HEK 293 cells. 

Gyros Protein Technologies and Cygnus Technologies to Develop Impurity Reagent Sets

Sanjay Sharma is vice-president and head of technology transfer at Lupin Pharmaceuticals.

Amol Galande is senior manager of the process development laboratory at Lupin Pharmaceuticals.

Robert Rhoades is managing partner at Validant.

A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals.

Assessing Manufacturing Process Robustness

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

New Pilot-Scale Lyophilizer Aids Biologics Drug Development

What can the biopharma industry learn from its rapid response to the COVID-19 pandemic?