BioPharm International Editors

Dr. Marcus Michel will take over the role from Richard Stedman, who has served as CEO for the past three years, as he transitions to a special advisor role for the company.

Through the acquisition, PTI will gain access to LDA’s lead product, the SIMS 1915+, a helium leak test system that combines its helium leak detection technology with its SIMS software for data collection and analysis.

The company will expand its micronization abilities for highly potent drug compounds through this investment.

The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

The virtual showroom will provide real-time construction updates, various specs, and services that its new super plant, Plant 4, will offer upon completion.

The companies have entered into an agreement for next-generation, mesothelin-directed CAR-T cell therapies for the treatment of solid tumors.

A longer-than-expected scale up of raw materials forces Pfizer to cut 2020 vaccine production in half.

Startup company Vivlion has signed a non-exclusive license agreement with ERS Genomics granting access to CRISPR/Cas9 patent portfolio.

New data from CGT Catapult has demonstrated progression by the industry toward commercialization of therapies and an increase in GMP manufacturing space.

Lonza has formed a long-term, strategic collaboration with a global biopharma company for bioconjugation.

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

A novel PTA technology captures more than 95% of the genomes of single cells, providing more uniform, accurate, and reproducible single-cell analysis data.

The collaboration addresses the need for risk mitigation plans in cell therapies.

Set to be operational by the first quarter of 2022, the 140,000-ft2 facility will feature up to six 2000-L, single-use bioreactor systems along with additional harvest and purification equipment to produce up to 100 commercial batches annually.

The gene therapy increases the ability of retina cells to make a soluble form of CD59, a protein that shields the retina from damage, to prevent additional damage and to preserve vision.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

Under the terms of the partnership, Colorcon will work to accelerate i2O’s research and development efforts.

CGT Catapult has launched the Advanced Therapies Skills Training Network, designed to open career opportunities and upskill staff in advanced therapy and vaccine manufacturing in the UK.

eTheRNA Immunotherapies has entered into a strategic cooperation and product license agreement with China Grand Pharmaceutical and Healthcare Holdings to form a new joint venture company, Nanjong AuroRNA Biotech.

The grant will support the advancement of glycoengineering technology for plant-derived proteins developed by a University of Alberta scientist partnered with PlantForm.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

MHRA has granted a temporary authorization for emergency use to Pfizer and BioNTech for the mRNA vaccine against COVID-19.

The expansion will include new suites for the development and clinical manufacturing of drug product intermediates and drug products and cGMP suites for early-phase cGMP manufacture.

The added space will house a portion of its PVC, polyurethane, silicone, and additional plastic tubing products, as well as its AdvantaPure products.

Originally announced in March 2020, the acquired facility will be Bora’s first North American manufacturing facility and will serve as its North American headquarters.

The virtual assessments will address problems, issues, and questions customers have about their environments and operations.

The expansion is part of a new expansion initiative aimed at increasing flexibility, efficiency, and cost-effective production.

Behzad Mahdavi, PhD, will join a team of experts in the company’s Science and Technology Group to fast-track the adoption of new development and drug delivery technologies and manufacturing processes and techniques.

The companies have entered into a global collaboration and license agreement to develop zuranolone (SAGE-217) for major depressive disorder, postpartum depression (PPD), and SAGE-324 for essential tremor and other neurological disorders.