Manufacturing

While technology promises advances for healthcare, a skilled workforce is needed to deliver on the potential.

More published data and initial regulatory approvals are needed to drive adoption of continuous bio-manufacturing.

Process understanding and careful assessment of risks are essential in developing viral clearance programs.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

Thermo Fisher Scientific invests $50 Million to expand biologics drug development and manufacturing capabilities in St. Louis, MO.

The new platform is expected to speed up cell line development.

The company unveiled three new products to support single-use biomanufacturing and won an award for best technological innovation at INTERPHEX 2018.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.

The company will build a high-volume manufacturing facility for their glass packaging product in Durham County, NC.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.

Under this global collaboration, the companies will develop encapsulated cell therapies for treating Type 1 diabetes.

Celltrion received complete response letters from FDA for its rituximab and trastuzumab biosimilars.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

The contract development and manufacturing organization announced the addition of a new building complex that will house its headquarters in Bothell, WA.

Fujifilm acquires cell culture media companies Irvine Scientific Sales Company and IS Japan.

RGtimeline/Shutterstock.comParenteral product quality is improving.

Early adopters are benefiting from lower costs and increased productivity.

Keystone Folding Box has added a new line of secondary packaging systems for injectable pharmaceutical products.

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.

This is the first of a series of three articles about validation and technical transfer in the bio- pharmaceutical industry.