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Considerations in Demonstrating Interchangeability with a Reference Biologic Product
Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.
BioLife Solutions Completes Acquisition of SAVSU Technologies
The acquisition strengthens BioLife’s position as a supplier of disruptive, enabling solutions used for manufacturing, storage, and distribution of cell and gene therapies.
Eurofins Genomics Acquires Blue Heron Biotech, Expands Gene Synthesis Capabilities
The acquisition expands Eurofins Genomics’ gene portfolio while bolstering Blue Heron’s production capabilities.
HALIX Completes New cGMP Manufacturing Facility; Startup Slated for Q4 2019
The new facility will manufacture biopharmaceutical products under cGMP conditions.
GSK US Pharma Head Steps Down
Jack Bailey, president, US Pharmaceuticals, GlaxoSmithKline, will step down from his position at the end of 2019 and will be succeeded by a Merck KGaA executive.
Protein Analyzer Offers Ability to Measure Protein Titer Directly from Bioreactor
The Tridex Protein Analyzer from IDEX offers the ability to directly measure protein titer from a bioreactor in real time.
PTC Therapeutics Acquires Biologics Facility from Bristol-Myers Squibb
The facility will support gene therapy production and continued development of PTC’s pipeline of investigational medicines.
Bayer Acquires BlueRock Therapeutics, Boosts Cell Therapy Stake
The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.
South Korea’s Biotech Industry Projected to $23.2 Billion by 2022, According to Industry Report
South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.
Sartorius Stedim Biotech Launches New Mammalian Cell Bank Services
The company has launched new services for mammalian cell bank manufacturing under GMP conditions.
FDA Publishes Guidance on Rare Pediatric Disease Priority Review
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
FDA Gives Guidance on Developing Treatments for Fabry Disease
The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
FDA Assessing Data Accuracy in Zolgensma Approval
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
Monitoring and Control of Inline Dilution Processes
Successful process intensification with inline dilution requires effective monitoring and control.
Drug Importing Back on Center Stage
FDA, Health and Human Services, and the Trump Administration back cheaper foreign drugs to cut pharma costs.
NIIMBL and FDA Partner in Biopharmaceutical Manufacturing
NIIMBL announced it is partnering with FDA through the University of Delaware to improve biopharmaceutical manufacturing.
Bayer Recalls Product Due to Mislabeling
Bayer is voluntarily recalling two lots of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials because they contain the incorrect product.
Iontas, Teva Enter New Antibody Optimization Agreement
Iontas and Teva Pharmaceuticals have entered into an agreement for the application of technologies and know-how into the optimization of human antibodies to be used as biotherapeutics.
ISA Announces Founding Members of Global Cybersecurity Alliance
Founding members of the Global Cybersecurity Alliance are Schneider Electric, Rockwell Automation, Honeywell, Johnson Controls, Claroty, and Nozomi Networks.
Olon Constructs Fermentation Facility in Italy
Olon began construction of a GMP facility for biologic APIs in Capua, Italy.
Cytena Establishes Subsidiary in Taiwan
Cytena Bioprocess Solutions, a new Cytena subsidiary in Taiwan, will provide bioprocess solutions for pharmaceutical companies and research institutes.
Abcam Acquires EdiGene’s Entire Live Cell Lines and Lysates Portfolio
Abcam has acquired the entire live cell line and lysates portfolio of gene-editing therapy developer, EdiGene.
Sartorius Stedim Biotech Launches Single-Use Vessel for ambr 250 Modular Bioreactor
Sartorius Stedim Biotech has unveiled a new single-use vessel for its ambr 250 modular benchtop automated mini bioreactor system that has been specifically designed for therapeutic cell lines.
Catalent Biologics Announces Long-Term Strategic Agreement to Develop Zolgensma
Catalent Biologics has entered into a long-term strategic agreement to develop and manufacture an AveXis gene therapy treatment for spinal muscular atrophy (SMA), Zolgensma.
Catalent Breaks Ground at $112-Million Drug Product Manufacturing Facility
Catalent recently held a groundbreaking ceremony at its Bloomington, Indiana pharmaceutical fill/finish site.
FDA Releases Guidance on Electronic Submissions
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
USP to Provide Free Access to Quality Standards for AACP Students
The US Pharmacopeial Convention is partnering with the American Association of Colleges of Pharmacy to provide students with free access to quality standards.
Connecticut Manufacturer Gets FDA Warning Letter
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
Gilead and Galapagos Announce Global R & D Collaboration
Gilead Sciences gains rights to clinical and preclinical programs in Galapagos’ portfolio through a 10-year global research and development collaboration.
Boehringer Ingelheim Acquires Immunotherapy Platform
Boehringer Ingelheim will combine assets from its cancer immunology portfolio with the KISIMA immunization platform from AMAL Therapeutics.
