Manufacturing

Ori Biotech is partnering with manufacturers and materials suppliers to develop an automated system for cell and gene therapy manufacturing.

Vibalogics is contracted to manufacture Janssen's COVID-19 candidate vaccine at its GMP-accredited facility in Cuxhaven, Germany.

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.

Single-use processing requires instruments providing the accuracy of traditional technologies but configured in form factors designed specifically for this service

Synthetic depth filters are a suitable option to provide a high-performance and scalable single-step clarification process.

The company will invest $180 million to construct a new 290,000-ft2 facility in Plainville, MA.

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.

The Coalition for Epidemic Preparedness Innovations will invest up to $384 million of additional funding, in addition to the $4 million it invested in March, to advance the clinical development of NVX-CoV2373, Novavax’s COVID-19 vaccine candidate.

Quartic.ai and Bright Path Laboratories have agreed to develop an artificial intelligence (AI)-powered continuous manufacturing platform for APIs and other small-molecule drugs using Bright Path Labs’ continuous bioreactor and the Quartic.ai smart manufacturing technology.

CMO Evonik begins capacity expansion of APIs and intermediates at its sites in Dossenheim and Hanau Germany to increase EU supply security for drug products.

The center will be located at NJIT’s Life Sciences and Engineering center and will feature two good manufacturing practices suites that are expected to be completed and operational during the summer of 2020.

Remote, machine health monitoring services reduce the need for on-site visits.

Catalent will manufacture a mRNA-based COVID-19 vaccine for clinical trials and potential commercialization.

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

Will moving at “warp speed” to develop a vaccine impact efficacy or safety?

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

Equipment and process optimization must be considered for scaling up these developmental technologies to commercial production.

Many antibody-drug conjugate therapies are in the pipeline; however, only a handful have been approved. What are the bottlenecks?

Discovery of carcinogenic nitrosamines in three of the world’s most widely prescribed drugs is driving efforts to better detect, control and prevent their generation in APIs and finished drug products.

A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.

Bioprocessing advances improve product yield, cut costs, and streamline integration between upstream and downstream processes.

The ASTM standard describes how to evaluate single-use systems for foreign particle analysis.

Supplier of punches and dies to tablet producers, I Holland, has reported that it will be revisiting its webinar series, investigating best practices in tablet manufacture, for those currently working from home.

The new cell-line producing platform enables fully scalable production of high-performance adeno-associated virus vectors.