The US Pharmacopeial Convention posted for public comments on its revisions to the USP Medicare Model Guidelines, which are posted for a 30-day public comment period, beginning Oct. 1, 2013.

Parameters for steam-sterilization autoclave overkill cycles should be chosen based on process understanding.

Capacity expansions and new products meet needs for inhaler and injector systems.

The UK regulatory agency issues statement of noncompliance against Wockhardt?s site in Chikalthana, India and Wockhardt?s contract manufacturer Nestor in the United Kingdom.

Governor Jerry Brown cites physician notification requirements for dispensing biosimilars as premature in the absence of FDA specifications for interchangeability.

Genzyme will build a facility in Massachusetts to expand purification capacity for Fabrazyme (agalsidase beta).

Adeline Siew Scientific Editor of Pharmaceutical Technology and Pharmaceutical Technology Europe talks to Joe Galati, Manager, Toxicology Services, Marvin Faber, Sr. Director, Global Head Environmental Health & Safety (EH&S), and Jeff Dinyer, Director EH&S & Global all from Patheon

MedImmune expands its antibody-drug conjugate capability through acquisition and collaboration.

Challenges in the formulation and manufacturing process of fixed-dose combinations

OncoMed Pharmaceuticals has been granted its first US patent on its MAbTrap antibody display technology.

Roche plans multimillion biologic manufacturing expansions in California, Switzerland, and Germany.

Recipharm has invested EUR 32 million ($43 million) in its Wasserburg, Germany site to expand lyophilization capacity.

The generic-drug manufacturer Teva Pharmaceutical Industries plans to cut 10% of its workforce.

Vetter is investing $100 million to expand filling capacity in Germany and the United States.

Global biotechnology financing through the first nine months of 2013 shows that initial public offerings are on the rise while venture-capital funding stays relatively flat.

Sartorius announces offer to acquire TAP Biosystems Group, a UK-based company.

Aesica expands aseptic capabilities at its Nottingham, UK site with the acquisition of new pre-filled syringes manufacturing equipment.

Use of a continuous-flow reaction made it possible to scale up a highly exothermic reaction for the production of a key Suzuki−Miyaura coupling reagent.

Fujifilm Diosynth Biotechnologies has renewed its manufacturing license from the UK's MHRA.

The need to develop a final formulation process for a parenteral product sensitive to stainless-steel gave Patheon the opportunity to evaluate the potential of single-use technology in fill-finish operations.

A recent market analysis offers a promising outlook for contract fill-finish and lyophilization services.

Catalent has acquired Relthy Laboratorios in Brazil to expand its South American softgel technology business.

ABC Laboratories plans to move operations of its subsidiary, Morse Laboratories, based in California, to Missouri.

Pfenex modifies its contract with US government for Anthrax vaccine.

AMRI has been awarded a seven-year contract for an active ingredient under clinical evaluation.

Carbogen Amcis has made several investments to increase capabilities in supplying antibody drug conjugates.

Hovione's plant in Portugal has successfully passed its twelfth FDA inspection in 18 months.

3M Drug Delivery will manufacture transdermal patch for ProStrakan.