Manufacturing

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The acquisition will place Cambrex into the finished dosage form CDMO market.

Fette Compacting’s FEC20 capsule filler for medium-sized batches is a smaller version of its FEC40 machine.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

The agency has issued a warning letter for cGMP violations at a drug manufacturing facility in Ahmedabad, India, that Baxter gained through its acquisition of Claris Injectables.

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

Pharmaceutical packaging designs evolve to protect children, while maximizing access for seniors.

CELLforCURE will produce cancer CAR-T treatments for Novartis at a manufacturing facility in Les Ulis (Essonne), France.

The media, by Tosoh Bioscience, is composed of calcium and phosphate buffers and offers mixed-mode properties for biomolecule purification.

Both parties have agreed to recognize each other’s inspection of manufacturing sites for a broader range of medicines, including sterile products, APIs, biologics, and vaccines.

Moderna’s new manufacturing plant in Norwood, MA gives the company capacity for preclinical and Phase I and II clinical manufacturing for its mRNA development candidates, including personalized cancer vaccines.

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.

The expansion at the company’s Gillingham, UK, site, worth EUR 9 million (approximately US$10.5 million), will improve the company’s distribution capabilities.

Certain blister card packages that do not meet US child-resistant packaging requirements are being recalled because they pose a risk of harm if the tablets are swallowed by children.

Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.

Bosch Packaging Technology’s GKF 720 capsule filling machine for small batches of hard capsules uses a fully automated, washable containment process.

Traditional glass and polymeric materials compete for market share in primary packaging for parenteral drug products.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.

The PowerMix Model PDM-10 from Ross, Charles & Son offers high-shear mixing for hard-to-mix applications with low flowability.

The BIOne 1250 bioprocess control station from Distek is a benchtop-scale bioreactor for mammalian and microbial models.

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.

This article highlights 15 years of changes in biopharmaceutical manufacturing.

The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.

Traditional barriers between upstream and downstream bioprocessing are slowly starting to break down, as biopharma embraces more advanced analytics and process control.

Vendors are offering template-based models and direct data-filing services to help smaller companies meet imminent deadlines.

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.