Pharmaceutical Technology Editors

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

The $10 million expansion, which will be completed and fully operational by February 2021, will add on 3760 square feet of production space.

The companies will work together to produce a wearable device that can subcutaneously deliver ketamine therapy as a non-opioid pain treatment.

Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.

The rebranding stems from the company’s expanded services which include 3PL services, supply chain transparency solutions, and retail pharma product procurement for over-the-counter medications.

Natoli installed a NP-RD30 rotary tablet press for R&D at its new lab in Germany.

Roche will gain full rights to Inflazome’s portfolio which includes clinical and preclinical orally available small molecule NLRP3 inhibitors.

Catalent will use T-knife´s TCR platform for a T-cell receptor-based cell therapy at its Gosselies, Belgium, site in order to manufacture clinical batches for European trials in 2021.

The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

The guidance document offers information on the placement and content of geriatric information in labeling of drugs and biologics.

The agency’s human medicines committee is endorsing the use of dexamethasone in COVID-19 patients requiring oxygen therapy.

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.

The companies aim to scale up production of Eli Lilly’s potential COVID-19 antibody therapies, pending regulatory approval.

BioNTech plans to produce up to 250 million doses of its COVID-19 vaccine candidate, BNT162b2, in the first half of 2021.

The new facility will produce cell therapies for clinical evaluation from discovery through to Phase 2b trials while expanding Takeda’s abilities to develop next-generation cell therapies.

The new particle counter allows users to import their standard operating procedure routine environmental monitoring maps and sampling configurations into the counter, which reduces human error and can improve data integrity.

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.

The APS system comes equipped with filter switching, liquid management, and cell bleed to reduce risk of human error and increase process robustness.

The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.

GenSight Biologics has submitted a marketing authorization application to the European Medicines Agency for Lumevoq.

Vizibl and Sanofi have entered into a Phase I partnership to streamline processes around supplier management.

A new brand name for its silicone healthcare solutions represents DuPont’s dedication to the creation of next-generation, innovative silicone solutions.

The companies will focus on the development and commercialization of Seattle Genetics’ ladiratuzumab vedotin and TUKYSA (tucatinib).

The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.