BioPharm International Editors

The cell therapy will be manufactured for each individual patient at BMS’ immunotherapy manufacturing facility in Bothell, WA, and will be launched across a network of treatment centers.

Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.

How can artificial intelligence and machine learning be used to gather and process real-time manufacturing data?

Through the agreement, AbbVie will use Caribou’s next-generation Cas12a CRISPR hybrid RNA–DNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies.

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.

The company has divested its specialty ingredients business and operations to Bain Capital and Cinven, two private equity firms.

Through the agreement, Catalent will manufacture Trizell’s Phase I cell therapy for the treatment of micro- and macroangiopathies at its Belgium facility.

FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus.

The study found that more than 90% of packages and cases scanned at three companies met all of the labeling requirements, with three years remaining until the final DSCSA deadline in 2023.

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

Catalent will offer materials from its gene therapy facilities in Maryland to support IND-enabling studies and a Phase I/II clinical trial of the product.

Through the acquisition, Jazz will gain access to GW’s novel cannabinoid platform, including Epidiolex, a plant-derived cannabinoid medicine for the treatment of high-growth childhood-onset epilepsy.

Scientists at the company learned that deagglomeration techniques lose efficacy through equipment wear over time and developed a tactic that makes up for the wear and prepares an ideal sample for each particle size test.

Both companies will provide resources and expertise to research, develop, and manufacture multiple mRNA vaccine candidates, including multi-valent and monovalent approaches.

The companies have entered into a research collaboration and license agreement for the potential treatment of rheumatoid arthritis via Imcyse’s RA program based on its Imotope technology.

As demand for COVID-19 vaccines increases, Big Pharma offers its manufacturing capacity and expertise.

Through the acquisition, Element will have access to Avomeen’s expertise in formulation chemistry, product manufacturing, extractables and leachables, and large molecule testing.

The companies previously entered into a collaboration in November 2020 with the goal of producing more than 100 million doses of the CureVac vaccine per year at Rentschler’s Laupheim, Germany facility.

WuXi STA will acquire the site’s operations and assets, including the plant, equipment, and workforce.

The deal, which is set to close by the end of the first quarter of 2021, will provide Horizon with access to Viela’s rare disease medicine portfolio.

The new board will join the company’s co-founder and chairman, Jay Walker, and company CEO, Franco Negron.

The vaccine will be developed using Gritstone’s proprietary prime-boost vaccine platform, which includes self-amplifying mRNA and adenoviral vectors, with antigens formulated by Gilead.

Bayer will support CureVac by providing the company with further development, supply, and territory operations via its clinical operations, regulatory affairs, pharmacovigilance, medical information, and supply chain management expertise.

The vaccine met the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a South African Phase IIb trial.

FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.

The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.