May 6th 2025
Incorporating sustainable practices into process designs as early as possible ensures optimal performance.
The shift toward personalized medicines poses new challenges in cleanroom protocols.
April 29th 2025
The company’s exhibitions will be focused in the areas of its pipeline, proprietary capsid engineering, and manufacturing.
April 24th 2025
April 22nd 2025
The commitment will include new, state-of-the-art R&D facilities as well as new or expanded manufacturing sites in multiple states.
The evolution of therapeutic modalities drives the adoption of single-use technologies.
Moderna Plans to Build mRNA Vaccine Manufacturing Facility in Canada
Moderna will build an mRNA vaccine manufacturing facility in Canada to provide access to domestically manufactured vaccines against respiratory viruses.
Evotec Opens Integrated Biologics Manufacturing Facility
The Just - Evotec Biologics facility in Redmond, Wash., uses the company’s J.POD technology.
Nobelpharma Signs License Agreement for ProBioGen’s Vaccine Manufacturing Platform
Nobelpharma has come to terms on an agreement to use ProBioGen’s vaccine manufacturing platform AGE1.CR.plX.
Packaging Components for Parenteral Drug Development
Datwyler offers the StarterPack packaging system designed to aid in the development of parenteral drug packaging.
EMA Endorses Track-and-Trace Recommendations
The agency is endorsing recommendations for global track-and-trace systems developed by the International Coalition of Medicines Regulatory Authorities.
Kyowa and Bora Partner to Produce Generic Product
Kyowa Pharmaceutical Industry and Bora Pharmaceuticals have announced a partnership to produce generic-drug product for filing in Japan.
AGC Biologics Acquires Cell and Gene Therapy Commercial Manufacturing Facility
AGC Biologics has acquired Novartis’ Longmont, Colorado, manufacturing facility for the commercial production of cell and gene therapies.
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.
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.
Metrics Contract Services Expands Greenville, North Carolina Facilities
Metrics Contract Services announces the completion of a $10 million expansion to their Greenville, NC facilities.
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.
TriRx Completes Acquisition of Elanco Animal Health Facility in Shawnee, Kansas
TriRx continues to expand its manufacturing capabilities with the acquisition of the Elanco Animal Health Facility in Shawnee, Kansas.
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.
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.
Sanofi Acquires Translate Bio for $3.2 Billion
Sanofi has acquired Translate Bio in a bid to further their mRNA research.
Nitric Oxide Nasal Spray for COVID-19 to Be Distributed to India and Other Asia Markets
Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.
DisperSol and Catalent Announce Manufacturing Collaboration
DisperSol and Catalent announce manufacturing collaboration to accelerate DisperSol’s pharmaceutical production.
FDA Launches New Crowdsourcing Challenge for Pediatric Research Questions
FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.
Serialization: Reducing Counterfeit Drugs and Increasing Sales
An effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.
Designing Incubators for Cell Therapy Manufacturing
Controlling conditions and preventing contamination are crucial for cell growth.
Implementing Data Integrity Compliance in a GLP Test Facility
Consider how to apply ALCOA+ to a building management system in non-clinical laboratories.
Working Towards Zero Emissions
Pharma and biotech supply chain companies are working together to help facilitate the transition of the pharma industry to net zero emissions compliance.
Regeneron and AstraZeneca Partner to Create Small-Molecule Obesity Drug
Regeneron and AstraZeneca have entered an agreement to create a small-molecule medicine designed to treat obesity.
Data Integrity Considerations for Vendor-Generated Data Associated with Analytical Testing
Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.
Packaging for Stability Studies: to Outsource or Not?
Developers might invest in small-scale equipment to produce packaging for stability studies in-house, or they might outsource production. Manufacturers should consider the benefits and risks to both approaches.
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.
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.