News

The agency published guidance on how sponsors of combination products can obtain feedback from FDA on scientific and regulatory concerns.

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.

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.

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

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.

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

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.

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.

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

Pharmaceutical laboratories must keep lab data integrity practices in mind in order to properly handle the effects of the COVID-19 pandemic.

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.

After a difficult year, bio/pharma science delivers promising results.

Transparency and open-dialogue are vital to sway the vaccine-hesitant community.

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.

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

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.

The expansion of the companies’ partnership will integrate lead optimization efforts to advance cancer immune therapy drug discovery.

Dolomite Microfluidics and MilliporeSigma have begun a collaboration to release off-the-shelf microfluidic device kits for the fabrication of PLGA particles.

The new powerful, precise, and compact instrument can be retrofitted for point-of-care clinical testing at urgent care facilities, hospitals, or physicians’ offices.

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

A holistic approach to validation and quality assurance is essential.

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

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.