Manufacturing

Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.

CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.

Hovione will double its manufacturing capacity in New Jersey with an expanded facility and a commercial spray dryer designed to handle potent APIs.

The US Pharmacopeial Convention preposts its new chapter on sterile preparations for compounding pharmacies for public review.

There is growing interest in the development of liquid formulations in prefilled syringes and autoinjectors, which offer convenience and ease of administration in a home setting.

Cobra Biologics and the University of Manchester announce a collaboration to improve industrial scale-up of mammalian cell bioprocessing.

In testifying before Congress on FDA regulation of long-awaited biosimilars, Janet Woodcock emphasized the importance of ensuring that the evaluation of new therapies is based on sound science.

Novo Nordisk will build a local manufacturing plant for FlexPen prefilled insulin delivery devices in Iran.

ReposiTrak signs agreement to pilot track and trace system in pharma.

IMA Active’s new tablet press machine, Prexima, is designed to deliver higher productivity and efficiency.

The company is keen to show how new packaging technologies can incorporate patient-focused elements.

Supersonic spray-drying process yields stable and soluble amorphous nanoparticles.

Preventing contamination requires quality systems to be in place, including routine cleaning, a robust cleaning validation program, and preventive maintenance.

Nexvet Biopharma, a veterinary biologics developer, secured a dedicated, cGMP biologics manufacturing facility in Tullamore, Ireland, and plans to invest in disposable technology.

Manufacturers challenge details in new policies designed to promote access to important therapies.

Abenza acquired biopharmaceutical CDMO PacificGMP and expanded the company’s San Diego facility.

According to AstraZeneca, the purchase of the biologics bulk plant will double the company's biologics manufacturing capacity in the US.

SGS Life Science Services announced that its facility in Fairfield, NJ, has been upgraded to be Biosafety Level 2 (BSL-2) compliant, according to the Centers for Disease Control and Prevention (CDC) guidelines.

The Krämer KCP10 upward-conveying capsule polisher elevates, polishes, and dedusts capsules.

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

FDA warns that compounded or repackaged drugs stored in certain syringes made by Becton-Dickinson may lose potency because of an interaction with the rubber stopper.

This agreement is a follow-on to an established collaboration between LobSor and Recipharm for the development and the manufacturing of Lecigon batches for the recently completed clinical trial.

As EU supplier risk assessment deadlines approach, a number of voluntary third-party auditing and certification options are available. Will more excipient suppliers, and drug manufacturers, use them?

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Suppliers indicate prices for single-use equipment are likely to increase.

The industry is moving towards more flexible manufacturing with the use of modular facilities and single-use systems.

Industry Expert Q&A with Robin M. Silva, Partner, Morgan, Lewis, and Bockius LLP

Adents’ Pharma Suite serialization software features track-and-trace capabilities.