Manufacturing

Sterile-molded filling assemblies from AdvantaPure are suited for single-use vial and syringe filling.

Pharmaceutical companies and contract manufacturing organizations report lack of readiness for the November 2018 US Drug Supply Chain Security Act serialization deadline.

A review of 2017 advancements from the Open-SCS working group with Charlie Gifford, group technical director.

New technological advancements seek to improve pharmaceutical process monitoring and control.

Open standards based on GAMP and GS1 will soon be released and more companies are moving beyond basic compliance.

Advances in TFF and single-use systems help advance UF/DF on the continuous processing path.

Conducting stability testing on APIs/finished drug product helps ensure shelf-life storage.

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

Recent investments show expansion activity in cell culture facilities.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

The recall was initiated due to a product complaint in which white particulate matter, identified as mold, was discovered in a flexible bag from one batch.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

BioTek Instruments has released a second edition of its BioSpa software that now offers users a simplified but effective interface for kinetic imaging or detection workflows.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, has filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

The Quattroflow QF10k size pump from PSG, a Dover company, has been added to its line of quaternary, four-piston diaphragm pumps.

The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

Children with a rare brainstem-based cancer might be helped by a new immunotherapy that targets a mutated protein found exclusively in cancer cells.

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.