Formulation and Drug Delivery

The acquisition of Protein Sciences, a vaccines biotechnology company, strengthens Sanofi’s influenza vaccines portfolio.

FDA halts unproved stem-cell cancer treatments administered to California patients, which was derived from a commercially unavailable military-grade vaccine.

The generic pharmaceuticals firm has sold its Baddi, India formulations manufacturing facility following a recent fire at its joint-venture plant in Algeria.

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

The first program of this collaboration will focus on the development of a candidate for severe acute pancreatitis.

FDA approves new molecular entity developed by Pfizer for treating a rare form of leukemia in adults.

The withdrawal has been attributed to issues at the biotech company’s manufacturing facility.

Sensors and communication capability support proper usage, improve compliance, and may enable telemedicine.

The antibody therapeutic failed to meet its primary endpoint in a Phase III study.

Catalent Applied Drug Delivery Institute (CADDI) announced that Jim Spavins, a veteran pharmaceutical industry executive, has joined the institute’s advisory board.

Cambrex is investing $24 Million in new, highly potent API manufacturing capacity at its Charles City, Iowa site.

FDA requests more detailed information on a post-marketing study for Dynavax’s hep-B vaccine, which will require an extended review time past its August 2017 PDUFA date.

Through its life-sciences business, MilliporeSigma, Merck KGaA will collaborate with Baylor College of Medicine to advance vaccine development for neglected and emerging diseases.

Lonza further expands its micronization services with the acquisition of Swiss contract manufacturer, Micro-Macinazione, following its previous $5.5-billion acquisition of dosage form provider, Capsugel.

The Washington-headquartered biotech firm plans to use the newly purchased facility to produce antibodies for its current and future pipeline.

Following passage by the House in July 2017, the Senate has voted to pass a reauthorization bill for FDA user-fee programs for drugs and medical devices ahead of the user-fee programs’ expiration date.

CordenPharma is investing €10 Million in a new line at its Plankstadt, Germany site.

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker. 

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.

FDA urges manufacturers to seek fast approval of “high-need” generics and targeted therapies. 

Watson-Marlow Fluid Technology Group (WMFTG) has expanded its range of peristaltic cased pumps for upstream and downstream bioprocessing tasks.

Sartorius Stedim Biotech has expanded its range of single-use membrane chromatography solutions with Sartobind Cassettes, a pod-like modular system for commercial applications in both capture and polishing.

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.