Manufacturing

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

ILC Dover’s soloPure flexible aseptic isolator creates a closed environment for sterile filling.

The new Abzena facility will initially include four modular suites with up to two 2000-L bioreactors, followed by the addition of two more 2000 L suites.

The ATMPS and Ori Biotech collaboration aims to improve visibility and reporting of cell and gene therapy manufacturing through a pre-integrated data solution.

Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.

In collaboration with the Singapore Economic Development Board, the new site will supply the Asian region and will include multiple fully digitalized modules for the production of three to four vaccines simultaneously

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

The UK's National Horizons Centre has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific training.

The company has introduced Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.

Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

Intensified and distributed manufacturing approaches create flexible, local capacity.

Manufacturers in Europe and the United States have announced plans for new in-country API development and manufacturing capabilities.

Although vials and prefilled syringes have different advantages, both find use in vaccine fill/finish.

Decontamination, automation, and containment are important considerations for aseptic manufacturing in isolators.

After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.

The availability of materials is a critical factor when it comes to vaccine capacity.

Raman spectroscopy delivers real time, non-destructive process insights for critical process parameters to monitor pharmaceutical manufacturing.

Predictive computational methods are finding wider use in pharmaceutical solid dosage development, particularly in mixing and blending, to improve tech transfer and equipment selection, and speed the acquisition of process understanding.

Manufacturers of oral solid dose pharmaceutical formulations need PAT tools to reduce a product’s time-to-market and increase profitability.

Tests evaluated commercial rotary tablet presses to see how effectively they deal with problems such as poor flow, overlubrication, and capping.

Dosage-level authentication provides an added digital layer of security for pharmaceutical companies to ensure their products are not exposed to falsification.

A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.

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

Set to be operational in 2026, the new facility will provide added antigen and filling capacity for Sanofi’s influenza vaccine, increasing its availability in Canada, the United States, and Europe.

The expanded agreement will include aseptic fill/finish services at its San Diego, CA facility.

GSK will provide filling capacity at its Barnard Castle facility in England.

Celonic will manufacture CvnCoV at its facility in Germany.

The partnership will combine Cold Chain Technologies thermal packaging with B Medical Systems’ stationary refrigeration solutions for temperature-critical pharmaceuticals.

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021.