Manufacturing

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

Everyone may not be ready for the deadline, but open standards based on GAMP and GS1 will soon be released; more companies are also leveraging what they’ve learned from serialization to improve overall efficiency.

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.

Implementation of the Packaging Serialization Standard cuts serialization costs, shortens deployment time, and expedites compliance with anticounterfeiting regulations.

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

FDA sent a warning letter to Deserving Health International Corp. after inspectors found CGMP violations including failure to prevent microbiological contamination.

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, have 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.

MJR PharmJet's MicroJet Reactor technology is a continuous process for producing nanoparticles with tightly controlled particle size and particle size distribution.

The company is seeking approval from FDA for use of the drug, migalastat, to treat Fabry disease in patients who have amenable mutations.

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The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.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

The Endress+Hauser iTHERM TrustSens hygienic RTD self-calibrates to verify in-line that the sensor is working as designed

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

The company is expanding its 380,000-square-feet Molex Little Rock facility to include a FDA-registered manufacturing center of excellence for connected health and drug-delivery devices.

Oceasoft has updated its line of Bluetooth-enabled temperature data loggers for shipping and logistics applications.

The contract research, development, and manufacturing organization has expanded API aseptic manufacturing capacity at its Valladolid, Spain, facility.

A survey by LNS Research and sponsored by Honeywell showed that industrial companies are not moving quickly to adopt cyber security; calls on CEOs to take action.