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.
Grand River Aseptic Manufacturing Completes Phase II of Facility Expansion
Grand River Aseptic Manufacturing has completed phase II of its facility expansion with the installation of two new sterile filling lines.
ProBioGen Executes Master Service Agreement with NextPoint Therapeutics
ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.
Validair Diamond Scientific Installs New Cleanroom
Validair Diamond Scientific has installed a new cleanroom for in-house testing, research, and training.
Modernization of India’s Pharma Manufacturing Industry: “Leader” or “Laggard”
Guest contributor B.S. Sathya Durga discusses the importance of modernizing India's pharmaceutical manufacturing industry.
The Evolution of Cellular Therapies in a New Clinical Research Environment
The clinical trial research environment has evolved because of specific solutions designed to overcome uncertainty.
Oregon Freeze Dry Opens $7.5 Million Biopharma Facility
The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.
Deciding Where to Outsource in Biopharma Development and Manufacturing
Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.
Driving Manufacturing Improvements Through Viral Vector Advances
The growth in demand of viral-vector-based gene therapies drives continuous efforts to improve viral vector manufacturing.
Developing Automation Downstream
Automation enables intensification of downstream processes.
Outlining Successful Steps for Scale-Up and BLA Filings
Successful scale-up and BLA filings for products manufactured by microbial biomanufacturing require strategic planning.
Overcoming Engineering Challenges to Enable Commercial Scale mRNA Vaccine Manufacturing
This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.
Continuous Processing for Viral Vectors
Manufacturers are taking the first steps toward process intensification.
DuPont Opens Biopharma Tubing Manufacturing Site in South Carolina
DuPont’s new manufacturing site will expand its biopharmaceutical tubing manufacturing capabilities.
WuXi STA Opens a New Large-Scale Continuous Manufacturing Plant
WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.
I Saw the Future of Global Pharmaceutical Production in India
Guest contributor Frederic Kahn discusses the state of the Indian pharmaceutical manufacturing industry.
TFF Pharmaceuticals Expands R&D Operations with New Facility
TFF Pharmaceuticals is expanding its R&D operations with a new facility in Austin, Texas.
Cytiva Acquires Chromatography Resins Manufacturing Facility in Muskegon, Michigan
Cytiva has acquired a new chromatography resins manufacturing site in the United States as part of its $1.5 billion capacity expansion investment.
Pfizer and Touchlight Enter Patent License Agreement for Use of dbDNA
Pfizer and Touchlight have signed a patent license agreement for Pfizer to use Touchlight’s doggybone DNA (dbDNA) in the manufacture of mRNA vaccines, therapeutics, and gene therapies.
Wacker Biotech Expands Germany Site with Construction of New mRNA Competence Center
Wacker is investing more than €100 million (US$100.5 million) to expand its Halle, Germany, site with an mRNA competence center.
US Government to Support Expansion of Croda Lipid Systems Capability
Croda has entered into an agreement with the US government to support the expansion of its lipid systems capability.
VeriSIM Life and Mayo Clinic Team Up to Co-develop New Therapies
VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.
Automating Biopharma Manufacturing
Automation and digitalization work together in the digital plant.
Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?
The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.
Evolution to a New Clinical Research Environment for Cellular Therapies
Finding specific solutions to overcome uncertainty has led to the evolution of a new clinical trial research environment.
Plant-based Expression Systems are Gaining Mainstream Advantage
Industry adoption of plant-made biologics remains slow, but plant-based technology gains an advantage by mainstream exposure.
Specialty Polymers Add Value to Single-use Technologies for Biopharmaceutical Processing
Specialty polymers demonstrate the advantages of single-use consumables in biopharmaceutical manufacturing.
The Road Ahead for the Pharma Cold Chain
Improved real-time visibility during all segments of handling, transportation, and delivery is keeping costs low and reliability high while helping time- and temperature-sensitive biopharmaceuticals to go the distance without incident.
FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses
Following the recommendation of an independent vaccine panel, FDA is advising vaccine manufacturers to include an Omicron BA.4 and BA.5 component to their booster doses.
Getinge Launches New DPTE-EXO with Sleeveless DPTE-BetaBag for Aseptic Transfer
Getinge’s new DPTE-EXO with Sleeveless DPTE-BetaBag is an alpha port with an external opening and an integrated funnel for automated aseptic transfer.
Inceptor Bio Collaborates with University of Minnesota to Develop Cell Therapy Platform
Inceptor Bio and the University of Minnesota aim to build a novel iPSC platform to accelerate cell therapy drug development.