Aligning mRNA Progress with Regulatory Streamlining
FDA Accepts Alnylam’s Application for Cardiomyopathy Treatment
The agency will review the company’s supplemental new drug application for vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy.
Quality Pitfalls of Aging Facilities and Equipment
Operating in an aging facility and/or utilizing outdated equipment may lead to drug shortages and high operating costs.
How Modularization and Digital Delivery are Transforming Pharma Manufacturing
Modular and replication strategies are being utilized to meet growing demand for CDMO facilities.
Extracellular Vesicles and Fluorescence Excitation-Emission Matrix Spectroscopy
Fluorescence spectroscopy offers unique advantages for characterizing EVs.
FDA Approves Kedrion's Bolognana Plant for Production of PLGD-1 Therapeutic
With FDA's clearance, Kedrion can manufacture Ryplazim (plasminogen, human-tvmh), the first and only FDA-approved therapy for treating PLGD-1, at its Bolognana, Italy, site.
Fujifilm Completes Expansion of Cell Therapy Facility
The company officially launched new production suites, a revamp of its development labs, and more at its Thousand Oaks, Calif., cell therapy manufacturing facility.
Pii Invests $3.6 Million to Boost Prefilled Syringe Capabilities
With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.
Abzena Launches GMP Cell-Based Potency Testing in US and UK Sites, Boosting Analytical Capabilities
The company will now include GMP cell-based potency assays at its Cambridge, UK, and San Diego, Calif., sites expanding its early and late phase analytical capabilities.
Sanofi Invests €40 Million to Boost Antibody Production in France
The investment will allow Sanofi to strengthen antibody bioproduction at its Lyon Gerland site in France.
Circio Forms Collaboration with Certest to Develop LNP Formulations
Under the collaboration, the companies will create and test circVec DNA–LNP formulations with an eye toward potential therapeutic applications.
BioPharmaSpec Launches Three New R&D Facilities in Europe
The new European facilities located in German, Italy, and Lithuania will specialize in drug discovery and R&D services.
SEKISUI Completes CDMO Capacity Expansion for CGMP Biopharma Manufacturing
Under a £15.7 million (US$20.7 million) investment, SEKISUI has expanded its UK site for clinical-grade drug substance manufacturing.
Alentis Therapeutics Gains $181.4 Million Funding to Advance Anti-Claudin-1 ADCs in Solid Tumors
With financing led by OrbiMed, Novo Holdings, and Jeito Capital, Alentis Therapeutics will develop a pipeline of Claudin-1-targeted ADCs to treat solid tumors.
FDA Approves PTC Therapeutics’ Gene Therapy for AADC Deficiency
The approval of eladocagene exuparvovec-tneq (Kebilidi) marks the first FDA approval for a gene therapy to treat AADC deficiency.
Frontier Scientific Solutions to use $1.5 Billion Funds to Establish Global Free Trade Zone Gateway for Life Sciences Supply Chain
Empowered by a $1.5 billion commitment from a major investor, Frontier Scientific Solutions has unveiled its plans for establishing a global free trade zone gateway intended for facilitating the life sciences supply chain using Wilmington International Airport in North Carolina.
