Facility Design and Engineering

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.

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

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

Lonza introduces new modular complex that offers flexibility and individually tailored solutions to biomanufacturing challenges.

The company has broken ground on a R&D and process development facility in Missouri.

Improving the bioreactor growth environment increases the rigor of bioprocessing runs.

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

The Basel office will house the clinical development team and other functions to progress the company’s lead compound emapalumab.

The process control and automation requirements of single-use systems differ from those of stainless-steel equipment.

In a press release, Momenta announced on Feb. 16, 2017 that Momenta/Sandoz’s fill/finish contract manufacturer, Pfizer, received a warning letter for the manufacture of the 40 mg of Glatopa (glatiramer acetate injection), Momenta’s generic version of the drug Copaxone. Pfizer said in the statement that the warning letter does not affect the production or shipment of the 20 mg version of the drug, which is already approved by FDA.

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

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

Oxford Genetics increased its laboratory space to 5700 sq. ft. with a move to a new location at Oxford Science Park.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.

The time and resources required to finalize post-approval changes may be preventing manufacturers from modernizing facilities, or even scouting for new technology.

The company announced that it will build a new manufacturing facility at the GMR Aerospace Park at the Rajiv Gandhi International Airport in India.

Genentech’s biologics drug substance plant is the overall winner of the International Society for Pharmaceutical Engineering’s 2016 FOYA Awards.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

Susan Schniepp, Distinguished Fellow at Regulatory Compliance Associates, discusses the regulatory requirements for improving manufacturing lines.

The authors present a case study in which four single-use vessels were fitted to an existing bioreactor system.

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

A streamlined approach may enhance process efficiency and product quality.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.