Manufacturing

Novavax will sell two Maryland-based vaccine development and manufacturing facilities for Catalent’s expanding gene therapy footprint.

Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

New testing equipment for seal integrity of pharmaceutical packaging improves accuracy and flexibility.

A presentation at the Leistritz Pharmaceutical-Nutraceutical Extrusion Seminar explained how simulation tools benefit the development process.

The companies have signed a strategic multi-year manufacturing agreement for the future commercial production a late-phase investigational cell therapy.

Lyophilization Services of New England acquired a sterile injectables manufacturing facility in León, Spain.

A groundbreaking ceremony was held in Rahway, NJ for Merck’s new FLEx facility that incorporates G-CON’s prefabricated cleanroom units.

The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.

Jefferson established the Jefferson Institute for Bioprocessing workforce training institute in collaboration with NIBRT using the GE Healthcare FlexFactory Platform to produce biopharmaceuticals.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

CDMO iBio introduced cGMP sterile fill/finish services at its facility in Texas.

Although continuous approaches offer significant benefits for some products and processes, batch manufacturing is not going away any time soon.

A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.

With an increased focus on the supply chain security of non-cGMP intermediates, companies need to re-emphasize upstream manufacturing.

Wearable and smart devices allow user-friendly subcutaneous drug delivery.

Continuous manufacturing may offer huge opportunities, but it will not be right for every facility or product.

Protecting the integrity of raw data is crucial to regulatory compliance and to proving that manufacturing and quality operations are being run and managed properly.

The Ross VCB-0.25 Tumble Blender is suited for specialty blends with extremely minor active components and additives.

Sartorius Stedim Biotech’s Generation 2 ambr 15 cell culture microbioreactor system offers increased flexibility and expanded capability for clone selection, media and feed optimization, and early process development work.

The EnviZion hygienic diaphragm valve from ITT Engineered Valves allows for simplified installation and maintenance.

CDMO, Vibalogics, has revealed that it will be acquired by a private equity firm, Ampersand Capital Partners.

Knauer has introduced new columns and screening services for the enantioseparation of chiral substances.

A new facility to be built in the Philadelphia Navy Yard will support commercial production for autologous tumor-infiltrating lymphocyte cell therapy products from Iovance Biotherapeutics.

The expansion will increase the company’s single-use capacity to meet growing demand.