Manufacturing

Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.

Single-use technologies are starting to gain ground as capacity needs change, but industrywide adoption remains low.

BioPharm International asked Andrew Bulpin, head of Process Solutions at MilliporeSigma, about the end-of-life options for disposable components of biopharmaceutical single-use systems.

The new Acquity Arc Bio System by Waters is specifically engineered to enable efficient transfer and improvement of bioseparation analytical methods.

A manufacturing disruption has led to an EpiPen shortage in Canada, which currently has no alternative auto-injectors available on the market.

The contract development and manufacturing organization has invested £30-million (US$42 million) at its Dundalk, Ireland site to offer expanded clinical trial services.

The company relocated its headquarters to Riverview, Florida.

Meissner Filtration Products has acquired PDC Aseptic Filling Systems, a supplier of aseptic filling systems and sealers, to expand Meissner's automated platform offerings.

Corning will feature its 3D bioprinting technology and tools to support 3D cell culture at booth #1029 during the SLAS 2018 conference on Feb. 3-7, 2018 in San Diego, CA.

Comecar will provide cell culture equipment for biopharmaceutical company CO.DON AG's new production site in Leipzig, Germany.

The company will invest $139 million in sterile manufacturing technology at its facility in Ballytivnan, Sligo, Ireland to support the growth of its oncology pipeline.

Clover Biopharmaceuticals will use GE's FlexFactory biomanufacturing platform with single-use bioreactors to produce innovative and biosimilar fusion protein products in China.

The funding from the Walloon Region will enable Univercells to start developing a manufacturing platform aimed at driving down costs of biosimilars manufacturing.

Lonza Pharma & Biotech's's Modular Automated Sampling Technology (MAST) platform, which allows for the collection of up to 10 sterile sample sources for automated analysis in multiple analytical devices, won the CPhI Pharma Award 2017 for Excellence in Pharma: Bioprocessing.

GE Healthcare will equip Cellular Biomedicine Group's cell therapy manufacturing facility in Shanghai, China, with its FlexFactory single-use platform, designed to speed up cell therapy manufacturing timelines.

Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.

A new target for the treatment of multiple myeloma using CAR-T technology was discovered by researchers at Osaka University.

An antibody-based Zika virus therapeutic that protected monkeys from infection might be safe enough for administration to pregnant women.

Sartorius Stedim Biotech will equip Abzena’s contract development and manufacturing facilities in Bristol, PA, and San Diego, CA, with single-use equipment and scale-up technologies.

Athenex is moving forward with the construction of a new 320,000-square-foot pharmaceutical manufacturing facility in Dunkirk, NY, and has hired the German engineering firm, M+W, to design and construct the facility.

Pharma Team Up has launched Poseidon, an integrated ocean freight program, to address the disconnect between pharma companies and their logistics providers.

AptarGroup’s Landfill Free Certification program addresses the issue of waste production from pharmaceutical manufacturing processes by prompting its facilities to reduce and reuse operation waste.

The companies aim to discover and develop locked nucleic acid oligonucleotides as orally available therapies for treating inflammatory bowel diseases.

The companies aim to develop a potential zinc finger protein transcription factor-based gene therapy for treating Lou Gehrig’s disease.

FDA Commissioner Gottlieb expects that the saline and amino acid drug shortages from Puerto Rican manufacturing facilities will improve in the early part of 2018.