Manufacturing

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

FDA noted in a recent inspection that US Stem Cell Clinic was processing and administering stem cell treatments that were neither reviewed nor approved by the agency.

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

Laboratory tests can determine critical cleaning parameters for passivation treatments used to prevent rouge on GMP stainless-steel equipment.

Ajinomoto Althea’s Optima VFVM 7000 aseptic fill/finish line supports a range of drug substance APIs.

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

Roquette, a biopharmaceutical company specializing in plant-based excipients, announced the opening of a new R&D and customer technical service facility in Singapore in fall 2017.

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.

AstraZeneca and Champions will develop new cohorts of patient-derived xenograft models to be used in oncology programs in breast and lung cancer as well as for use in other academic and industry applications.

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

The International Society for Pharmaceutical Engineering (ISPE) announced its Europe Pharma 4.0 Conference, taking place November 23 – 24, 2017 in Verona, Italy.

The agency published guidance on identifying trading partners under DSCSA.

GlaxoSmithKline (GSK) opened a new vaccine manufacturing facility in Montrose, Scotland. The £44 million (US$57 million) facility will be used to manufacture aluminum salts, which are used for vaccine production.

Efforts to establish an international system for identifying and tracing drugs through the global supply chain are moving forward.

The acquisition adds sterile manufacturing capability to the CDMO’s services, which include API formulation and manufacturing.

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.

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.

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

The International Society for Pharmaceutical Engineering (ISPE) introduced its Biopharmaceutical Manufacturing Conference, happening December 4–6, 2017 in San Francisco, California.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

Amid debate about “fake news,” peer-review papers offer vital, objective insight.

Improved resin chemistries and customized separation solutions are enabling more efficient separations.