BFS technology can help maintain sterility during the biologics manufacturing process.

Improving Sterility Using Blow-Fill-Seal Technology

Both demand for and investment in fill/finish capacity continue to rise.

Focus on Fill and Finish

Biopharma focuses on streamlining biomanufacturing and supply chain issues to drive uptake of cell and gene therapies.

Growth in Cell and Gene Therapy Market

Topic

Tareq Jaber, tareq.jaber@crl.com, is associate director at Charles River Laboratories.

Anja Tessarz, Anja.Tessarz@crl.com, is associate director RGDB, SME Viral Clearance at Charles River Laboratories.

Articles

The design of viral clearance studies must keep pace with the quickly evolving biologic drugs industry.

Viral Clearance Studies: Challenges and Beyond

Chris Spivey is the editorial director of 

mRNA may not be a train we necessarily all need to get onboard immediately, but we should know where the central train station is located, and what it connects us to.

mRNA Hauptbahnhof

The agreement will see Immutep and Merck KGaA, Darmstadt, Germany jointly fund the INSIGHT-005 study.

Pfizer, Merck KGaA, and Immutep Enter into Second Clinical Trial Collaboration Agreement

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

CellVax and Theragent Form Manufacturing Pact for Novel Cancer Immunotherapy Drug Candidate

Webcasts

Webinar Date/Time: Wed, Dec 7, 2022 11:00 AM EST


Biologics CDMO: Four Critical Aspects of Clinical Development, Manufacturing & Analysis

Christian Goesker is managing director of CRB Group.

Thomas Lederer is office lead, director EPCM Projects, CRB Group.

Mike Barrett is vice president, Project Delivery Services, CRB Group.

By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.

How Integrated Project Delivery Enables Speed: A Phase-By-Phase Guide 

Ravi Samavedam is chief innovation officer at Azzur Group.

In the all-too-common debate over building lab facilities versus outsourcing, the best strategy may be the middle ground: licensing.

Threading the Needle Between DIY and CDMO

Julie Lippke works in analytical research and development at Pfizer Inc. (Groton, CT).

Joseph Mongillo works in analytical research and development at Pfizer

Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).

Christian Metz works in Analytical Research and Development at AbbVie Inc., Ludwigshafen, Germany.

Katria Harasewych works in quality at Merck & Co., Inc. (Kenilworth, NJ).

Fouad Benamira works in Analytical Development Sciences for Biologicals at UCB S.A. Belgium.

The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.

A Harmonized Approach to Performing a Risk-Based Audit Trail Review

Ryan Campbell is the technical consultant manager for Rockwell Automation.

Kevin Schreier is the director of process engineering for IPS-Integrated Project Services, LLC.

Through collaboration and transparency, engineering and automation companies can achieve great efficiencies and success for their customer by integrating intelligent design into a facility.

From Design to Qualification: Creating the Most Efficient Single-Use Facilities

Nicola Gardner is senior product marketing manager at Thermo Fisher Scientific.

By taking a digital maturity-first approach to Pharma 4.0, manufacturers can optimally position themselves for success.