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.
MilliporeSigma to Supply Lotte Biologics with Biologics Manufacturing Capabilities in US
MilliporeSigma and Lotte Group will collaborate on facility design and workforce training for a new biologics business unit in the US.
Avantor Partners with GeminiBio on Custom Hydrated Solutions and Cell Culture Media
Under the collaboration, Avantor and GeminiBio will offer custom cGMP solutions to enhance process efficiency and accelerate speed-to-market of novel emerging therapy modalities.
MilliporeSigma Intensifies Upstream Processing with New BioContinuum Seed Train Platform Offering
MilliporeSigma’s new BioContinuum Seed Train Platform offering enables a fully closed bioprocessing environment for both fed-batch and perfusion N-production.
ImmunoGen Partners with Oxford BioTherapeutics to Develop Novel ADCs
ImmunoGen has formed a research collaboration with Oxford BioTherapeutics to develop novel antibody-drug conjugates for cancers with high unmet needs.
First Successful Efficacy Study Against Omicron With COVID-19 Vaccine
The Sanofi-GSK vaccine is the first candidate to demonstrate efficacy in a placebo-controlled trial with a high-Omicron environment.
Batavia Biosciences Increases Capacity for Viral Vectors and Vaccine R&D in the Netherlands
Batavia Biosciences is expanding its headquarters and R&D capabilities in its Netherlands facility.
SCHOTT to Triple Vial Production Capacity in the US
SCHOTT is planning to triple its ready-to-use vial production capacity in the United States to meet increasing demand for storing injectable drugs.
Merck Collaborates with Agilent Technologies on PAT for Downstream Processing
Merck has entered into a collaboration with Agilent Technologies with the aim of filling the industry gap in PAT for downstream processing.
Exothera, LogicBioTherapeutics, and Polyplus Collaborate on Industrial-Scale AAV Manufacturing
Exothera, LogicBioTherapeutics, and Polyplus-transfection, are collaborating on the development of a scalable AAV manufacturing platform.
Yourway Announces New European Depot in Dublin
Yourway intends to construct a new manufacturing facility in the Dublin Airport Logistics Park.
REGENXBIO Launches New Gene Therapy Manufacturing Facility in US
REGENXBIO has opened a new in-house facility at its headquarters in Rockville, Md., that will be used to manufacture AAV gene therapies at commercial scale.
Astellas Opens New US-based Large-Scale Gene Therapy Manufacturing Facility
Astellas Pharma has opened its new gene therapy manufacturing facility in Sanford, NC, which will support clinical- and commercial-scale manufacturing of AAV vectors for gene therapies.
Seqirus Announces Completion of $156 Million Expansion of Vaccine Manufacturing Facility
The expansion at Seqirus’ Holly Springs, N.C., manufacturing facility will support the formulation and fill/finish of influenza vaccines.
Lilly to Invest $2.1 Billion in New Indiana Manufacturing Facilities
Eli Lilly and Company plans to build two new manufacturing sites at Indiana's LEAP Lebanon Innovation and Research District in Boone County.
Pfizer to Invest $120 Million in COVID-19 Oral Treatment Production
Pfizer will invest $120 million to produce COVID-19 oral treatment in the US.
Adopting a Modeling Approach for Preclinical Studies
One can use modeling methods to generate data and shorten development timelines in preclinical studies.
Employing Genomics Tools to Accelerate Drug Development
Advances in genomics tools can lead to quicker biotherapeutic development.
Pre-filled Syringes Show Strong Growth
Demand spurs innovations in syringes and syringe fill/finish operations.
Coming Together to Enable Cell and Gene Therapy Manufacturing
Precompetitive consortiums seek solutions to industry-wide challenges.
Pharmaceutical Transport Container
The KTEvolution from Tower Cold Chain is a lightweight, reusable container designed for the transport of pharmaceutical products.
Next-Generation Cas9 Proteins
Thermo Fisher's Invitrogen TrueCut HiFi Cas9 Protein significantly reduces off-target events while retaining maximum on-target editing efficiency.
Is AI a Panacea for Pharma’s Productivity Gap?
AI could provide solutions to critical manufacturing inefficiencies.
Lonza, IBF Collaborate to Support Development and Manufacturing of Biologics and Small Molecules
Lonza and Israel Biotech Fund form a two-year agreement to support accelerated development and manufacture of biologics and small molecules.
AGC Biologics Adds Viral Vector Suspension Technology at New US Campus
AGC Biologics is investing in viral vector suspension technology at its new Longmont, Colo., facility.
Lubrizol Launches Apisolex Technology
Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.
Vaxzevria Gains Approval in EU as a Third Dose COVID-19 Booster in Adults
AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.
FDA Stresses Risk Management Plans
The agency is asking drug manufacturers to ensure a strong supply chain by developing risk management plans.
Catalent Invests $175 Million to Expand Manufacturing Capabilities and Capacity in US Facility
Catalent has announced a $175 million project to expand its manufacturing facility for large scale oral dose forms at its Winchester, Ky, site.
Preparing for the Future: Expanding Capacity and Facilitating Multi-modalities
CDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.
Converting Injectable Therapies to Combination Drug-Device Products
The author describes how to seize market opportunities while navigating the requirements of both drug therapies and delivery devices.