Manufacturing

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.

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

Industry experts weigh in on best practices, challenges, and mutual recognition of cleaning validation standards.

Managing and prioritizing risk is essential to ensuring raw material quality. USP is developing new guidelines to make the work easier.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.

Partnership aims to develop new vaccine regimens against hep B and HIV by combining respective proprietary vaccine technologies.

Stainless-steel particulates were found in one lot of 0.9% Sodium Chloride Injection, USP 1000 mL, prompting the recall to the hospital/user level.

New patent for automated cell processing technology provides commercially viable automated CMC solution for developing CAR-T cell therapies.

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