News

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 collaboration will add diversity to Alexion’s commercial portfolio and will give the company access to Portola’s commercialized medicine, Andexxa (coagulation factor Xa [recombinant], inactivated-zhzo).

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.

EMA's Committee for Medicinal Products for Human Use has recommended that all ranitidine medicines be suspended within the European Union as a result of the presence of low levels of NDMA.

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

Through the acquisition, Orbis will work to heighten Adare’s Pharmaceutical Technologies business, which handles the development and manufacturing of products for pharmaceutical, animal health, and over-the-counter markets.

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

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

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.

Kindeva Drug Delivery plans capital investment and jobs growth.

FDA approved hydroxychloroquine sulfate for emergency use as a treatment for some hospitalized patients with COVID-19.

Fujifilm allocates production volumes for COVID-19 treatments in 2021 at its Denmark facility.

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster.

Policy makers seek to ensure supplies of new therapies and to limit shortages.

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

Having a better understanding about compliance will be of benefit when looking for a job or for furthering one’s career, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

In light of the hype around chloroquine and hydroxychloroquine as potential COVID-19 treatments, it is important to remember that drug repurposing should never be rushed, irrespective of the urgency of the situation.

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

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.

The goal of the collaboration is to manufacture up to one billion does per year of mRNA-1273, Moderna’s vaccine against the novel coronavirus.

Sartorius adds chromatography systems and resins, tangential flow filtration, and biomolecular characterization technologies.

Manja Boerman tapped as president of Cell & Gene Therapy for Catalent with retirement of Pete Buzy.

Private equity firm, Ampersand Capital Partners, has made a majority investment into contract packaging organization (CPO), Tjoapack.

Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

The Cambridge Design Partnership and the Stevanato Group have announced a partnership that will see the development of a new pen-injector based on the Axis-D technology and IP licensed from Haselmeier in 2019.

ILC Therapeutics, a biotech company based in the United Kingdom, has discovered two separate novel treatments for patients suffering with COVID-19 prior to needing ventilators.