Formulation and Drug Delivery

Guidance Answers Questions on GDUFA

July 25, 2017

The agency has published a Q&A guidance document related to self-identification of facilities, review of generic drug submissions, and inspections.

Boehringer Ingelheim Expands Fremont Manufacturing Facility with $217 Million Investment

July 24, 2017

Manufacturing capacity will be increased by one third and approximately 300 new high-wage and highly-skilled jobs will be created at the Fremont site.

GE, Oritain Partner on Bovine Serum Traceability

July 24, 2017

GE Healthcare partners with Oritain for an independent test that can confirm the country of origin of fetal bovine serum (FBS), a component of biopharmaceutical production.

BioPhorum Launches Biomanufacturing Technology Roadmap

July 24, 2017

Industry collaboration group releases technology roadmap to address pressure on biopharmaceutical manufacturers to innovate biomanufacturing processes.

Catalent and Rutgers University to Study Pediatric Drug Challenges

July 21, 2017

Catalent Applied Drug Delivery Institute announced a partnership with Rutgers University to examine the challenges of pediatric drug formulation and delivery.

Single-Use Technologies Transform Biopharmaceutical Facilities and Manufacturing Equipment

July 19, 2017

Equipment and Processing Report

The advantages of single-use systems become clear as they become more broadly implemented.