Regulatory, analytical, and process concerns must be considered.

Validating mAb Bioprocesses

Novel coronavirus can pose threats to bioprocessing.

SARS-COV-2 and Bioprocessing

Topic

Articles

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

Aseptic/Sterile Processing

Cleanroom Equipment and Supplies

Clinical Trial Materials

Equipment

Facility Design and Engineering

Fill-Finish

Information Technology

Manufacturing Equipment, Biologics