Manufacturing

Vertex and CRISPR have amended their collaboration agreement to include the development, manufacture, and commercialization of CTX001, an investigational CRISPR/Cas9-based gene editing therapy for sickle cell disease and transfusion-dependent beta-thalassemia.

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

CalAmp's new sensor for cold-chain applications provides visibility for shipping vaccines.

Material properties play a role in container closure integrity under frozen or cryogenic storage temperatures.

CordenPharma’s expansion will include the addition of new production lines which will be merged into the lipid manufacturing process in April 2021.

Drug product security requires anti-counterfeiting techniques such as authentication throughout the supply chain.

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

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.

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.

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.

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.

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

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 companies will aim to establish clinical and commercial supply agreements for Plus Therapeutics’ RNL-liposome drug product at the appropriate stage of development.

The fund will focus on emerging life science companies with novel platforms and methods to improve therapeutic outcomes and those with technologies that support science research, development, and manufacturing.

Romaco, supplier of processing and packaging equipment, has acquired STE Tecpharm, S. L., a Spanish manufacturer of processing technology.