
PTSM: Pharmaceutical Technology Sourcing and Management
Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

PTSM: Pharmaceutical Technology Sourcing and Management
Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

Equipment and Processing Report
Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

Lonza will continue to sponsor the conservation of horseshoe crabs, which are used in endotoxin testing.

The ambr 250 is a mini bioreactor system for parallel fermentation or cell culture.

The agency cited a Memphis drug compounder for misbranded drugs and a lack of appropriate sterile processes.

The issues cites the Taiwan facility with violations of current good manufacturing practice regulations.

FDA cited a Las Vegas compounding pharmacy for sterility violations.

FDA sent a warning letter to The Compounding Pharmacy of America for deficiencies in sterile manufacturing.

The company will be exhibiting at the 2016 International Fuel Ethanol Workshop and Expo.

The agency published guidance on the nonclinical evaluation of osteoporosis treatments.

Merck will acquire Afferent Pharmaceuticals for $500 million in cash with the potential for additional payments.

At the conference, industry experts discussed regional trends and challenges for the Middle East and North Africa for 2016.

FDA approved Vaxchora intended for travelers who are at risk for the disease.

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.

Mandatory use of the periodic safety update report repository becomes mandatory on June 13.

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

The agency publishes three final guidance documents on drug compounding.

The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.

The agency cited KO DA Pharmaceutical Co. with cGMP violations.


The company plans to introduce HDX–MS in quarter three of 2016 at its West Chester, PA facility.

The company showcased new technologies at ASMS for biopharmaceutical characterization.

The company opened a 200,000-square-foot facility in Kakegawa, Japan to serve the needs of domestic and global clinical trial sponsors.

MilliporeSigma surveyed 250 biopharmaceutical executives on how their companies will manage new risks associated with the changing biopharmaceutical landscape.

The new company is the product of a merger with Formex.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.