Manufacturing

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021.

Under the terms of the agreement, Thermo Fisher will construct and operate a 44,000-ft2 cell therapy development, manufacturing, and collaboration center on UCSF's Mission Bay campus.

Univercells will introduce the intermediate capacity scale-X carbo system to NIBRT’s facility for hands-on demonstration and training in CGT.

Sandoz plans to strengthen its European antibiotics manufacturing network by expanding its production capabilities in Kundl, Austria, and Palafolls, Spain.

BD’s new high-tech manufacturing facility in Zaragoza, Spain, will create up to 600 jobs by 2030.

Colorcon’s new suite will provide clients with capabilities to develop prototype tablets or capsule dosage forms when API quantity is limited or the API potency requires a higher level of protection.

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Charles River plans to enhance its gene therapy capabilities through the acquisition of Vigene Biosciences.

WuXi Biologics and WuXi STA have established a joint venture company named WuXi XDC to provide contract development and manufacturing of bioconjugates, including antibody-drug conjugates.

Technology advances and pandemic environment drive increased use of automation and digital tools.

A task force established by PDA and BioPhorum is establishing scientific data for integrity test activities.

Advances in automation and cleanroom technology improve efficiency for small commercial quantities of aseptically filled drug products.

Aseptic spray drying offers a technology alternative to manufacture thermally stable vaccines.

The sensitivity of droplet digital PCR helps manufacturers detect Mycoplasma contamination in AAV-based gene therapy products.

Contract packaging organizations packaging biologic drugs for clinical trials use technologies that meet the unique requirements of each study.

Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future.

Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value.

Blow-fill-seal (BFS) technology presents an economical option for single-unit dose delivery of vaccines.

The latest news about biologics facilities includes various expansions, new locations, and acquisitions in the bio/pharmaceutical space.

The expansion in Le Mans, France will support growth in clinical and commercial manufacturing.

The expansions will add peptide manufacturing capacity.

Originally established in the 1970s as a fetal bovine serum supplier, Fujifilm Irvine Scientific continuously proved its strength in the cell culture solutions space.

Sterling Pharma Solutions and OncoTEX have entered into a clinical development agreement for the manufacturing of OncoTex’s novel platinum-resistant oncology drug candidate, OxaliTEX, for use in clinical trials.

BioNTech plans to expand its global footprint by establishing its regional headquarters for southeast Asia and a new mRNA manufacturing facility in Singapore.

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.