PTSM: Pharmaceutical Technology Sourcing and Management-05-06-2015

PTSM: Pharmaceutical Technology Sourcing and Management

Capsugel Produces DPI Phase 2 Trial Supplies

May 04, 2015

Contract Services

11

5

Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.

Chinese API Manufacturer Warned for Data Integrity Issues

May 04, 2015

API Synthesis and Manufacturing

11

5

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Mylan Recalls Injectables Due to Visible Particulate Matter

April 28, 2015

Regulation and Compliance

11

5

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

FDA Releases Final Biosimilar Guidance

April 28, 2015

Regulation and Compliance

11

5

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Vetter Serializes First Product for South Korea

April 28, 2015

Supply Chain

11

5

CDMO Vetter produces identifiable labeling for a top-ten pharmaceutical company.

IDT Biologika Vaccine Facility Recognized

April 28, 2015

Contract Services

11

5

IDT Biologika receives 2015 Facility of the Year Award or facility integration from ISPE.

SGS Completes Expansion at Mumbai Facility

April 27, 2015

Contract Services

11

5

Stability testing and UPLC capabilities highlight expansion at Mumbai, India facility of SGS Life Science Services.

Serialization: Deja Vu All Over Again?

April 24, 2015

Supply Chain

11

5

As a special session at Interphex 2015 this week made clear, few pharma companies are ready for serialization and aggregation deadlines. The disconnect between pharmaceutical manufacturers and their contract partners poses a special risk.

Rentschler Biotechnologie Expands Single-Use Capabilities

April 17, 2015

Contract Services

11

5

Rentschler Biotechnologie expands European manufacturing capabilities with GE Healthcare Life Sciences bioprocess technologies.

Recipharm Invests in Sythonics

April 16, 2015

Contract Services

11

5

Recipharm makes a strategic investment in Synthonics and partners in development of novel compounds.