Drug Development

Barrett Fallentine is director of Product and Process Development, Pharmatech Associates, bfallentine@pai-qbd.com. 

Articles

Tech transfer is key to succession advancing biopharmaceutical pipeline products from research to preclinical.

Mind the Gap: Tech Transfer from Early Stage Cell Culture to Phase I Clinical Manufacture

Almac Sciences has announced the expansion of its technology capabilities within its API services and chemical development portfolio through implementation of continuous flow expertise.

Almac Group Implements Continuous Flow Expertise at Global HQ

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

Sanofi, Biomunex Sign Antibody Licensing Agreement

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Orphan and cancer drugs continue to lead, but treatments for many common diseases were also approved in 2018. 

FDA Marks Record Year for New Drug Approvals

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

FDA Hits Valsartan Manufacturer with Warning Letter

Antibody-based drugs offer new mechanisms of action and greater specificity.

Fighting Bacterial Resistance with Biologics

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

NIBRT, Valitacell Aim to Validate New Analytical Technology

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

ADC Bio Secures Additional Equity Round Investment

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

Analytical Best Practices for Raw Materials Testing

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

APIs and Excipients