How has the COVID-19 pandemic impacted biomanufacturing operations?

SARS-CoV-2 and Biomanufacturing

Filling vaccine vials and syringes must be fast and GMP-compliant.

Need for Fill/Finish Inspection Speed

Facility, equipment design, and experience matter. 

Rapid Changeovers in Biologics Manufacturing

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Articles

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.

Novavax COVID-19 Vaccine Trial Expands Enrollment

Edge-AI technology will enable Industry 4.0 automation in pharmaceutical manufacturing.

Neurala Partners with IMA Group on AI for Manufacturing Automation

The company’s new closed cell therapy processing system enables scalable, cost-effective development and manufacturing of cell therapies.

Thermo Fisher Scientific Launches Closed System for Cell Therapy Manufacturing

The new VirusExpress lentiviral production platform increases dose yields and reduces process development time for cell and gene therapies.

MilliporeSigma Launches Lentiviral Production Platform 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.

Abzena Invests in New $60-Million CGMP Manufacturing Facility

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.

Viral Vector API Characterization of Product-Related Impurities

Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.

Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA

Virtual Touring allows companies to inspect and visit vendor and contract partner sites remotely during the COVID-19 pandemic. 

Lachman Now Offers Remote Inspections

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.

HHS, DoD, AstraZeneca Enter into $486-Million Agreement for COVID-19 Investigational Product

Automation, digitalization, and supply-chain strategies help mitigate vulnerabilities in both autologous and allogeneic cell therapy manufacturing.

Navigating Cell Therapy Manufacturing Amid Pandemic Woes

An innovation such as synthetic biology can develop a consistently stable starting cell line for cell therapy source material.

Synthetic Biology Offers a Solution to Cell Therapy Source Material Constraints

Melisa Carpio is a global technology consultant for Cell Culture Technologies at Sartorius North America.

Bioreactor technology advances can offer seamless manufacturing scale-up and can reduce the timeline and cost of biologics production.

Current Challenges with Cell Culture Scale-up for Biologics Production 

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Reconfiguring Fill/Finish Inspection to Meet COVID-19 Vaccine Goals

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality. 

Glycoengineering Shows Promise for Enhancing Antibody Therapeutics

The technology is a novel, plasmid-free manufacturing system for robust and reproducible manufacture of AAV at scale.

Oxgene Launches TESSA Technology for AAV Manufacture at Scale

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. 

Novavax Begins Phase III Efficacy Trial of COVID-19 Vaccine 

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.

UK Prime Minister Visits Team Behind the Vaccines Manufacturing and Innovation Centre

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. 

Johnson & Johnson Launches Multi-Country Phase III Trial of Janssen’s COVID-19 Vaccine Candidate

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.

AstraZeneca and Samsung Biologics to Enter into Long-Term Supply Agreement for Up to $545.6 Million

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.