Manufacturing

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

An ordered process describing calculations activities for compounded dosage forms is described.

Webinar Date/Time: Tue, July 25, 2024 10:00 AM EDT

In an ASGCT Panel on nucleic acid- and cell-based vaccines in oncology, work on a personalized mRNA vaccine was highlighted.

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product.

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.

Webinar Date/Time: Mon, Jun 24, 2024 11:00 AM EDT

The new facility will be the company’s first to offer full manufacturing processing for antibody drug conjugates.

Bari Kowal, senior vice-president, head Development Operations & Portfolio Management, Regeneron, discussed the utility of AI and how it can benefit R&D work.

A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.

The new 80,000-square-foot facility will increase production of the company’s freeze-drying equipment.

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.

The drug discovery company intends for this new site to increase its reach in the region, supporting growing demands from its Asia-Pacific consumers.

Webinar Date/Time: Wednesday, June 5, 2024 at 11am PDT | 2pm EDT

The separation of deamidated capsids from non-deamidated capsids can be achieved using HIC, according to studies done by a team at Oxford Biomedica.

Phillip Gregory, PhD, senior vice-president and head of Regeneron Cell Medicines, Regeneron, discussed how engineering receptor architecture can be a tool to improve CAR-T cell sensitivity to tumor antigens.

Regeneron's Sven Moller-Tank, PhD, director of Viral Delivery Technologies, Regeneron Genetic Medicines, discusses the company's work in using bispecific antibodies for redirecting AAV target specificity.

A greater understanding of molecular and cellular biology and technological advancements are revolutionizing the field of biologics.

Experiments conducted by the downstream technology team at Spark Therapeutics involving metal ion-containing additives showed improved capsid clearance in AAV production.

Webinar Date/Time: Fri, May 31, 2024 11:00 AM EDT

ProPharm and PBL have introduced a fully automated, enclosed cell factory manufacturing device.

The two companies will combine their cell therapy platforms to develop convertibleCAR programs targeting solid tumors.

Digital transformation is allowing for better handling, analysis, and protection of vast data collection.

Webinar Date/Time: Tue, Jun 4, 2024 9:00 AM EDT

A comparison between polysorbates and HPβCD determines the better stabilizer for biologics formulation.

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

In this exclusive Drug Digest video interview, Chris Spivey, Director, Industry Relations and Strategic Partnerships, talks with industry experts about various aspects of drug product stability testing.

Global product manager at Cytiva, Eric Corti, discusses the challenges with designing a new single-use mixing system that ensures leak-free fluid handling operations at INTERPHEX 2024.

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

The CDMO plans to expand and upgrade its Philadelphia, Ohio, and Milan facilities to meet the continued growth in demand for high potency handling capabilities.