Category: Manufacturing

Manufacturing, Research and Development

Sensors Take on Undersampling in Biomanfacturing

September 15, 2020

Via: Genetic Engineering and Biotechnology News

When asked about the biggest challenge in today’s bioprocessing, Sandy Williams, PhD, a biomedical engineering expert at Scientific Bioprocessing (SBI) in Pittsburgh who focuses on regenerative medicine, says, “The biggest concern we have heard from the industry is that bioprocessing […]

FDA, Manufacturing, Regulations, Research and Development

FDA scolds Mylan for ‘repeated’ manufacturing problems

September 4, 2020

Via: Biopharma Dive

Before legal troubles and a challenging generics market wiped out much of its value, Mylan was an industry titan with a glowing manufacturing record to match. “There was a time, of course, that the very thought of Mylan receiving an […]

Clinical Trials, Manufacturing, Research and Development

CNS Pharmaceuticals Announces US Drug Manufacturing Milestones

September 3, 2020

Via: BioSpace

CNS PHARMACEUTICALS AG, Inc. (NASDAQ: CNSP) (“CNS” or the “Company”), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, today provides an update on progress for the U.S. manufacturing […]

Manufacturing, Research and Development

Teva, on the heels of major reorg, plans to cut 350 more manufacturing jobs in Israel

August 24, 2020

Via: FiercePharma

After a multiyear effort to cut away roughly $3 billion in operational costs, Israeli drugmaker Teva could be expected to take a short break to its slice-and-dice efforts. Instead, Teva is keeping its foot on the gas pedal, and hundreds […]

Industry, Manufacturing, Research and Development, Vaccines

Therapure Signs Manufacturing Deal with VBI Vaccines

August 18, 2020

Via: Contract Pharma

Therapure Biomanufacturing, a division of Therapure Biopharma Inc., has signed an agreement with VBI Vaccines Inc. for the manufacture of their coronavirus vaccine candidates. Therapure Biomanufacturing is an integrated contract development and manufacturing organization (CDMO) focused on biologic and high […]

Manufacturing, Research and Development

Continually Collecting Virions for Manufacturing Biotech Products

July 7, 2020

Via: Genetic Engineering and Biotechnology News

The increasing demand for vaccines and gene therapies pushes the need to scale up manufacturing processes, such as producing virions from cell cultures. Gwendal Gränicher of the bioprocess engineering group at the Max Planck Institute for Dynamics of Complex Technical […]

Manufacturing, Research and Development

Digital Biomanufacturing Needs a Digital Supply Chain

July 7, 2020

Via: Genetic Engineering and Biotechnology News

Industry 4.0 gives the biopharmaceutical industry a way of making more effective and consistent products and increasing their earnings, according to Cate Rasche from Miebach Consulting’s pharma and life sciences center of excellence. “New technologies related to digital transformation have […]

Clinical Trials, Manufacturing, Research and Development

Regeneron Advances Antibody Cocktail into Phase III Trials

July 6, 2020

Via: Genetic Engineering and Biotechnology News

Regeneron Pharmaceuticals said today its double-antibody cocktail against COVID-19 is advancing into Phase III studies, less than a month after the start of its first clinical trial, with preliminary data from one study expected to be reported later this summer. […]

Industry, Manufacturing, Pharma, Research and Development

Molecular simulations show how drugs block key receptors

June 25, 2020

Via: ScienceDaily

G-protein-coupled receptors (GPCRs) are among the protein target groups of the greatest importance for drug development. These receptors react to, for example, light, flavours, smells, adrenaline, histamine, dopamine and a long list of other molecules by transmitting further biochemical signals […]

Manufacturing, Research and Development

SiO2 Scales Up Container Technology for COVID-19 Vaccines and Treatments

June 8, 2020

Via: Biopharm International

SiO2 Materials Science, a privately-owned U.S. advanced materials science corporation, has signed a $143-million agreement with the US government to accelerate scale up of its packaging technology for use in containers designed to store novel coronavirus (SARS-CoV-2) vaccines and therapeutics. […]

Manufacturing, Research and Development

Amneal Pharmaceuticals Recalls Metformin Hydrochloride

June 4, 2020

Via: PharmTech

Amneal Pharmaceuticals (Bridgewater, NJ) announced on May 29, 2020 that it is voluntarily recalling all lots of Metformin Hydrochloride Extended Release Tablets, USP, 500 mg and 750 mg, because of above FDA-acceptable amounts of N-Nitrosodimethylamine (NDMA) detected in the product. […]

Manufacturing, Research and Development

COVID-19 Will Have Long Lasting Impact on Biopharma Manufacturing

May 26, 2020

Via: Genetic Engineering and Biotechnology News

The COVID-19 pandemic will forever change drug and vaccine manufacturing, says an expert, who argues an Industry 4.0 approach will be vital. Efforts to develop a vaccine against the SARS-CoV-2 virus are accelerating. Some of the candidates are traditional-type vaccines […]