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© 2020 MJH Life Sciences and BioPharm International. All rights reserved.
© 2020 MJH Life Sciences™ and BioPharm International. All rights reserved.
How has the COVID-19 pandemic impacted biomanufacturing operations?
Filling vaccine vials and syringes must be fast and GMP-compliant.
Facility, equipment design, and experience matter.
October 27, 2020
The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.
October 23, 2020
Edge-AI technology will enable Industry 4.0 automation in pharmaceutical manufacturing.
October 20, 2020
The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.
October 16, 2020
The new VirusExpress lentiviral production platform increases dose yields and reduces process development time for cell and gene therapies.
The new facility at the company’s San Diego, CA, site will be for late phase and commercial CGMP manufacturing.
FDA’s final CMC guidance sets expectations for manufacturing and quality for human gene therapy INDs. This article reviews existing analytical applications, focusing on viral vector characterization of impurities.
October 15, 2020
Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.
October 13, 2020
Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic.
October 12, 2020
The companies are entering into an agreement for the late-stage development and large-scale manufacturing of AZD7442, AstraZeneca’s investigational product for treatment and prevention of COVID-19.
October 02, 2020
Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.
An innovation such as synthetic biology can develop a consistently stable starting cell line for cell therapy source material.
Bioreactor technology advances can offer seamless manufacturing scale-up and can reduce the timeline and cost of biologics production.
October 01, 2020
Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.
Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality.
The technology is a novel, plasmid-free manufacturing system for robust and reproducible manufacture of AAV at scale.
September 25, 2020
A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.
September 24, 2020
UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.
September 23, 2020
A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.
September 22, 2020
Samsung will offer large-scale commercial manufacturing for drug substance and drug products to support AstraZeneca’s biologics therapeutics capabilities in the Asia-Pacific region.
September 18, 2020
The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.