Content Spotlight
Podcast: Sustainability equals efficiency, says eXmoor
eXmoor Pharma discusses the steps taken to build a more sustainable facility, the importance of its design, and calls for industry to share advice and initiatives.
Latest News
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Facilities & CapacityNow open: Millipore’s Maryland facility slashes virus testing time
Now open: Millipore’s Maryland facility slashes virus testing time
The 250,000 square-foot site will house biosafety testing, analytical development, and cell-banking manufacturing services.
Deal-Making
Opencell and Adva partnership seeks to improve CGT manufacturingOpencell and Adva partnership seeks to improve CGT manufacturing
The companies' collaborative biomanufacturing service looks to take flight after an unlikely airport meeting.
Deal-Making
Recipharm and Exela collaborate to boost US sterile injectable productionRecipharm and Exela collaborate to boost US sterile injectable production
The partnership between contract development and manufacturing organizations (CDMOs) Recipharm and Exela enables production of over 100 million units (vials and pre-filled syringes) annually.
Facilities & Capacity
Industry looks to distributed model to overcome cell therapy shortcomingsIndustry looks to distributed model to overcome cell therapy shortcomings
A panel of experts discussed the difficulties and necessity of wide-spread adoption of cell therapy manufacturing at BioProcess International 2024 in Boston, Massachusetts.
Facilities & Capacity
Now open: Millipore’s Maryland facility slashes virus testing timeNow open: Millipore’s Maryland facility slashes virus testing time
The 250,000 square-foot site will house biosafety testing, analytical development, and cell-banking manufacturing services.
Global Markets
Recipharm and Exela collaborate to boost US sterile injectable productionRecipharm and Exela collaborate to boost US sterile injectable production
The partnership between contract development and manufacturing organizations (CDMOs) Recipharm and Exela enables production of over 100 million units (vials and pre-filled syringes) annually.
Facilities & Capacity
Ferring bolsters Adstiladrin production with Finland expansionFerring bolsters Adstiladrin production with Finland expansion
Swiss firm Ferring has opened a manufacturing facility in Kuopio, Finland to manufacture drug substance (DS) for its a bladder cancer gene therapy treatment.
Regulations
White House OSTP: ‘Whether Harris or Trump, biomanufacturing is bipartisan’‘Whether Harris or Trump, biomanufacturing is bipartisan’
A President Biden Executive Order supporting homegrown biomanufacturing will remain in place whoever wins in November, White House OSTP assistant director Sarah Glaven told Biotech Week Boston delegates.
Regulations
FDA inspector exposes most common regulatory violations at BWBFDA inspector exposes most common regulatory violations
Wei Wang, a microbiologist and inspector with the US Food and Drug Administration (FDA), said poor documentation is among the most common of CBER observations.
Therapeutic Class
Industry looks to distributed model to overcome cell therapy shortcomingsIndustry looks to distributed model to overcome cell therapy shortcomings
A panel of experts discussed the difficulties and necessity of wide-spread adoption of cell therapy manufacturing at BioProcess International 2024 in Boston, Massachusetts.
Sponsored Content
Maintaining Sterility Through CGT Processing and CryopreservationMaintaining Sterility Through CGT Processing and Cryopreservation
Cryopreservation in cell therapy and gene therapy manufacturing is critical to maintaining product integrity. The components used in the production of cell and gene therapies must be able to withstand temperatures of -130°C and lower – as well as the freeze-thaw cycles associated with processing, transportation, and administration to patients. The CGT industry is moving toward applying biopharmaceutical best practices in a way that meets CGT requirements. This white paper covers key issues in CGT processing including: READ WHITE PAPER CPC set the industry standard for sterile connection technologies with its AseptiQuik® G Series. It now offers the first aseptic connector solutions designed specifically for cryopreservation in CGT applications, featuring the MicroCNX® ULT Series. CPC is the industry leader in aseptic sterile connection technology
Upstream & Downstream Processing
Now open: Millipore’s Maryland facility slashes virus testing timeNow open: Millipore’s Maryland facility slashes virus testing time
The 250,000 square-foot site will house biosafety testing, analytical development, and cell-banking manufacturing services.
Upstream & Downstream Processing
Allterum partners with GBI to manufacture mAb for clinical trialAllterum partners with GBI to manufacture mAb for clinical trial
The Florida-based contract development and manufacturing organization (CDMO) will produce an antibody for acute lymphoblastic leukemia (ALL).