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.
Novavax and European Commission Finalize COVID-19 Vaccine Purchase Agreement
Novavax and European Commission have finalized an agreement to purchase up to 200 million doses of a COVID-19 vaccine.
BeiGene to Build New Manufacturing and Clinical R&D Facility in New Jersey
BeiGene plans to build a new campus for R&D and commercial-scale biopharmaceutical manufacturing in Hopewell, NJ.
Catalent Finalizes RheinCell Therapeutics Acquisition
Catalent finalizes their acquisition of iPSC developer and manufacturer RheinCell Therapeutics.
Syngene Announces Senior Level Appointments
Syngene International appoints two US-based executives to senior level positions.
Analysis Demonstrates No Increased Incidence of Thrombosis with TTS After Vaxzevria Second Dose
A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.
University of Sheffield and CGT Catapult Launch Innovative Gene Therapy Program
The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.
CHMP Approves Manufacturing Scale-Up for Spikevax
EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.
FDA Launches New Crowdsourcing Challenge for Pediatric Research Questions
FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.
Subunit Vaccines and the Fight Against COVID-19
Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.
Using Picodroplet Technology to Optimize Bispecific Cell Lines
Growing demand for bispecific antibodies increases the need for automated and miniaturized high throughput screening capabilities.
Cell Harvesting Sees Benefits from Automated Processes
Automation is one asset that benefits cell harvesting by cutting out laborious manual steps and minimizing contamination.
The Evolving Aseptic Processing Landscape
Through the adoption of single-use technology, drug manufacturers have been able to adapt to the challenges posed by the COVID-19 pandemic.
Designing Flexible Fill/Finish Facilities
Scenario modeling informs planning for current and future manufacturing needs.
Packaging for Stability Studies: to Outsource or Not?
Manufacturers should consider the benefits and risks of contract packaging for stability studies.
FDA Gives Green Light to Emergent BioSolutions to Resume COVID-19 Vaccine Manufacturing
Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.
FDA Grants Orphan Drug Designation to VICO Therapeutics for Huntington’s Disease Drug
VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA.
EMA Starts Rolling Review of Sanofi’s COVID-19 Vaccine
EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.
Summa Equity Acquires Majority Stake in Axion BioSystems
Summa Equity has acquired a majority stake in science tools business Axion BioSystems with the intent of further entering the CGT market.
908 Devices and Transcenta Partnership Leads to Workflow Innovations
Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.
J.T.Baker Robotic Tips from Avantor Offer Precision Workflow
Avantor’s newly unveiled J.T.Baker robotic tips is the latest in their line of automated precision plastics.
Cytiva and Pall Investing $1.5 Billion into Manufacturing Expansion
Cytiva and Pall reinforce recent expansion efforts with a $1.5-billion dollar investment in new manufacturing facilities.
FDA Approves Merck’s 15-Valent Pneumococcal Vaccine
Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.
Meissa’s Intranasal COVID-19 Vaccine Yields Promising Preclinical Data
Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.
PerkinElmer to Acquire BioLegend in $5.25-Billion Deal
PerkinElmer has entered into an agreement to acquire BioLegend, a global developer and manufacturer, in a deal valued at $5.25 billion.
Sinovac’s Eupolio Vaccine Gains Market Authorization in China
Sinovac Biotech’s Eupolio vaccine, a Sabin inactivated poliovirus vaccine (sIPV), has gained marketing authorization in China.
Catalent Invests $100 Million to Expand European Biologics Manufacturing Capabilities
Catalent commences the first phase of a $100-million expansion program Anagni site to increase its manufacturing capabilities for biologics drug substance.
Summa Equity Acquires Cleanroom Provider G-CON Manufacturing
Summa Equity has acquired a majority stake in G-CON Manufacturing, a prefabricated cleanroom provider.
Pfizer and BioNTech Announce Collaboration with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses Within Africa
Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute Ltd to manufacture the Pfizer-BioNTech COVID-19 vaccine for distribution within the African Union.
Catalent Biologics Launches New Cell Line Expression Technology
Catalent Biologics has launched its new cell line expression technology, GPEx Lightning, which aims to shorten drug substance development timelines by up to three months.
Samsung Biologics Partners with Kineta for Anti-VISTA Antibody Immunotherapy
Samsung Biologics and Kineta have entered into a strategic partnership for drug product manufacturing services and to support an IND filing of a novel antibody therapeutic.