Manufacturing

Primary packaging and container design reflects a move to patient-friendly formulations and delivery systems.

Excipient selection strongly influences lyophilization performance for biologic drugs.

There is much work to do to achieve efficient, cost-effective production processes.

This study aims at understanding the differences between porcine and bovine trypsin from both pancreatic and recombinant origins.

A Q&A with PCI Pharma Services about best practices for choosing and maintaining temperature sensors in cold and cryogenic storage.

Baxter will acquire Claris Injectables Limited, adding additional generic injectable capabilities to the company’s porfolio.

Emergent signed a follow-up contract to provide 29.4 million doses of BioThrax to the Strategic National Stockpile.

Univercells received a grant from the Bill & Melinda Gates Foundation for the development of a vaccine manufacturing platform.

GlaxoSmithKline opened a new vaccines R&D center in Rockville, MD creating up to 200 new jobs.

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.

John Ward, vice-president of Engineering at Patheon, discusses the potential for cross contamination in the manufacture of biopharmaceuticals.

Andrew Bulpin, head of Process Solutions Strategic Marketing & Innovation at MilliporeSigma spoke with BioPharm International about the requirements of expression systems in biosimilar development.

The baculovirus-insect cell system can produce large quantities of complex protein in a short period of time.

A novel coiled flow inversion reactor (CFIR) improves process productivity and performance.

Takeda will invest more than 100 million Euros to build a new manufacturing plant for its dengue vaccine candidate in Singen, Germany.

EMD Millipore’s Mobius Power MIX 2000 can mix buffers, culture media powders, and other challenging materials.

The company plans to expand access to its Prevanar 13 vaccine in humanitarian emergency settings.

The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.

Research by agency scientists may help speed development of Zika virus vaccines.

GS1 US published new guidelines in preparation for the serialization and traceability requirements associated with DSCSA.

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.

The study in 48 healthy adults will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of the RSV vaccine, SynGem.

UPS entered into a definitive purchase agreement to acquire Marken, a provider of supply-chain solutions for the life-science industry.

German biotech ARTES and Iranian biopharma manufacturer BioSun will develop an HPV vaccine.

By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of single-use technology.

New data analytics tools help solve complex problems in a biotherapeutic development process.

In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.

Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.

The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.