Online sessions on process and operational intelligence, PAT, cleanroom qualification, data integrity, and more.

2020 Bio/Pharma Virtual Congress: November 11, 2020

The manufacture of gene therapy vectors is shifting to more modern technologies.

Bioprocessing for Gene Therapy Viral Vectors

The set-up and optimization of a loss-in-weight feeder is demonstrated. 

Loss-in-Weight Feeding of Poorly Flowing Materials

Topic

Articles

Two FDA-funded projects at RCPE will look at real-time monitoring and control of drug tablet coating and developing a digital twin for drug production control.

RCPE Awarded FDA Funding to Develop Next-Generation Technology

Catalent has signed an agreement with Bone Therapeutics for the acquisition of Skeletal Cell Therapy Support SA (SCTS).

Catalent Acquires Bone Therapeutics’ Cell Manufacturing Facility 

3P Biopharmaceuticals, and Oxford University spin-out, SpyBiotech, have signed a vaccine contract manufacturing agreement.

3P Biopharmaceuticals and SpyBiotech Sign Vaccine Manufacturing Agreement

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

The CountQ system from Verista automates accurate counts of tray-loaded parts, including vaccine vials. 

Inspection and Reconciliation Machine Accurately Counts Tray Loads

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

Neurala Partners with IMA Group on AI for Manufacturing Automation

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

Navigating Cell Therapy Manufacturing Amid Pandemic Woes

Jennifer Markarian is manufacturing editor of BioPharm International.

Automation and tools for remote monitoring are finding increased use as pharmaceutical manufacturing adapts to pandemic restrictions. 

Pandemic Drives Digitalization in Bio/Pharma Manufacturing

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

Robert Brokamp is director Automation Services at Jacobs.

Adi Karisik is global technology leader for Operational Technology at Jacobs.

Ongoing and emerging cyber-risks to legacy operational technology systems in bio/pharmaceutical manufacturing must be addressed.

Tackling Cybersecurity Challenges in Legacy Systems

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

Agnes Shanley is senior editor of Pharmaceutical Technology.

Research is striving to make pharmaceutical processes more scalable by making them simpler and easier to replicate and control. Advances include 3D printing, as well as miniaturized and continuous processes, all of which are being aided by improved automation and analytics. 

Improving Agility Through Scalability

Modernizing Bioprocessing for Gene Therapy Viral Vectors

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Industry experts discuss challenges and best practices for scaling up manufacturing under a short deadline.

Scaling Up Fast 

Editor of Pharmaceutical Technology Europe

A comprehensive rewrite of Annex 1 has been proposed and aims to organize and structure requirements in 10 specific sections.