August 14th 2025
Third-party ICMC certification verifies multi-modality manufacturing readiness, meeting US and EU standards for advanced genetic therapies.
August 13th 2025
The Hopewell, N.J., site adds scalable, end-to-end viral vector production with integrated quality systems to speed clinical and commercial gene therapy programs.
August 12th 2025
The newly launched facility is located in The Woodlands, Texas, and will produce plasmid DNA as well as strengthen biopharma supply chains.
August 8th 2025
Biopharma’s future depends on seamless integration of technology, expertise, and strategy.
August 6th 2025
Increasing efficiency and quality through effective application of advanced technologies is becoming predominant.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
MilliporeSigma Expands Production Facility for Cell Culture Media
MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.
metabion Expands Oligonucleotide Production Capacity in Germany
German manufacturer metabion is conducting a multi-million euro expansion of its oligonucleotide manufacturing capacity in Munich East.
Protecting High-value Biologics at Every Turn
Cold chain stakeholders continue to innovate with new technology development, the use of advanced modeling and analytics capabilities, and the pursuit of strategic partnerships.
Pushing Forward in Next-Gen Antibody Development
Exploring new fields can bring novel antibody candidates to the pipeline.
Camena Bioscience Raises $10 Million to Pursue DNA Synthesis Technology
Camena Bioscience has completed $10 million in Series A financing on the back of growing demand for DNA synthesis.
Chime Biologics Forms mAb Development and Manufacturing Deal with Leads Biolabs and BeiGene
Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.
FDA Approves BioMarin’s Roctavian, the First Gene Therapy for Treating Severe Hemophilia A
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
Automation Aids Cell and Gene Therapy Production
Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.
Small-Scale Syringe and Vial-Filling Capability for Development of Robust Filling Processes, Smooth Tech Transfers, and to Resolve Manufacturing Issues: Summary of Key Learnings
Use of a small-scale filler can result in increased filling efficiency.
Choosing the Right Expression System for Complex Modalities
The choice of expression system requires wise consideration of product complexities.
Exploring How CPC Progresses Green Chemistry Practices
CPC presents a green alternative to chromatography that supports sustainable operations.
Weighing the Benefits of Single-Use Consumables
Experts outline the benefits of single-use consumables relative to traditional approaches.
Maurice Michel of Sweden Wins 2023 Eppendorf Award for Young European Investigators
The prestigious award, worth €20,000 (US$22,000), goes to Maurice Michel of the Science for Life Laboratory at Karolinska Institutet, Stockholm, Sweden.
Andelyn Biosciences Opens New CGT Manufacturing Headquarters
The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.
Saudi Arabia’ PIF Launches Lifera, a New CDMO
PIF has established Lifera, a new manufacturing entity that will manufacture, stockpile, and supply bio/pharmaceuticals both locally and through partnerships.
Enzene Biosciences Invests $50 Million into New Jersey Biomanufacturing Facility
India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.
Vaxxas Opens Manufacturing Facility for Clinical Trials and Commercial Products
The new facility also provides a plan for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally.
Mendus and NorthXBiologics Enter Cell Therapy Manufacturing Alliance
Mendus and NorthX Biologics will work to develop and commercialize Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.
Charles River Laboratories Launches LVV Packaging Plasmids
Charles River’s off-the-shelf lentiviral vector packaging plasmids are intended for use with cell and gene therapies.
Croda Pharma Breaks Ground on Excipients Manufacturing Facility
The new excipients manufacturing facility is expected to be completed in 2025.
Difficulties in Expanding CAR-T Cell Therapy into Solid Tumors
There are various challenges associated with the development of CAR-T therapies for solid tumor cancers.
Transduction for AAV with Sean Hart
Chris Spivey, editorial director, speaks with Sean Hart, CEO and SCO of LumaCyte, on percent transduction for AAV measured.
Biosimilar CDMO Capacity Increased in Samsung Biologics – Pfizer’s New Arrangement
The collaboration between Samsung Biologics and Pfizer will focus on long-term biosimilars manufacturing.
Life Science Sterile Filtration and Considerations for Single Use Integration
Webinar Date/Time: Thu, Jul 27, 2023 11:00 AM EDT
invoX Pharma Invests in pHion Therapeutics to Develop Next-Generation mRNA Vaccines
invoX Pharma has made a second tranche of investment in pHion Therapeutics to support further development of next-generation mRNA vaccines.
Pushing the Barriers in Next-Gen Antibody Development
New fields are being explored to bring novel antibody candidates to the pipeline.
Pulling Out All the Stops in mAb Manufacturing
Compliance with GMP standards remains an integral focus in bulk mAb manufacturing.
Addressing Cell Therapy Challenges Through a Modular, Closed, and Automated Manufacturing System
Scaling cell therapy production workflows requires the establishment of closed, automated steps.
WuXi Biologics Expands Manufacturing Capacity in Germany
WuXi Biologics is expanding its manufacturing capacity for drug substance and drug product at its sites in Leverkusen and Wuppertal, Germany.
Contract Testing Services Solidify Their Place in the Manufacturing Value Chain
Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.