Manufacturing

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.

Temporary power, HVAC, and oil-free compressor systems provide flexibility and control for pharmaceutical manufacturing facilities.

Regulatory, cultural, and technical differences between drug and device development can pose challenges to pharmaceutical combination product development.

Catalent expands gene therapy capabilities with $1.2-billion acquisition of Paragon Bioservices.

Considerations for monitoring impact, vibration, and temperature during package transportation and storage.

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.

The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.

The acquisition of GlaxoSmithKline’s manufacturing site in Cork, Ireland, will expand Thermo Fisher Scientific’s global footprint for complex API manufacturing.

A CPhI Middle East & Africa (MEA) expert has forecasted a boom in manufacturing in the region and has expectations that within five years some of the industry will be acting as contract manufacturers for the European market.

The partnership will focus on the commercialization of inducible promoters to improve biomanufacturing.

StarTab from Colorcon was designed to ensure functionality and stability for direct compression tableting.

GE Healthcare launches Chronicle GMP-compliant automation software for cell therapy manufacturing.

Empty and prefilled syringes must pass a range of quality control tests.

Quality cannot be verified through testing, especially at the limit of detection, and no test method can confirm the absence of a microbe or particle.

The highly customized nature of cell and gene therapy production means that manufacturing innovations for one therapy may not be easily transferable to others.

The new 40,000-ft2 facility will support Bayer's growing biologics portfolio in oncology, cardiology, and additional therapeutic areas.

Harvard University researchers used single-cell sequencing to identify a protein expressed uniquely by insulin-producing beta cells created from stem cells in the laboratory.