News Headlines

  1. Cellino's iPSC Manufacturing Technology Receives FDA Advanced Manufacturing Technology (AMT) Designation 5/19/2025

    Cellino, a leader in advanced biomanufacturing, today announced that its optical biomanufacturing technology for generating induced pluripotent stem cells (iPSCs) has received the FDA’s Advanced Manufacturing Technology (AMT) designation from the Center for Biologics Evaluation and Research (CBER).

  2. Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress In Support Of Clinical Trial Readiness 5/15/2025

    Cadrenal Therapeutics, Inc., a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy.

  3. Abzena Announces Establishment Of Scientific Advisory Board To Support Innovation Strategy 5/15/2025

    Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, has announced today the formation of its Scientific Advisory Board (SAB) comprised of biopharma industry experts with diversified expertise in Discovery Research & Development (R&D) and Chemistry, Manufacturing, and Controls (CMC).

  4. VintaBio Presents Data Demonstrating High-Efficiency AAV Vector Production Using Proprietary VintaProcess™ At 2025 ASGCT Annual Meeting 5/15/2025

    VintaBio, a biotech manufacturer specializing in high-yield, high-purity viral vectors for gene therapy, today presented data further demonstrating the advantages and productivity of its proprietary VintaProcess™ at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting.  

  5. AGC Biologics Partners With Quell Therapeutics To Advance T-Regulatory Cell Therapies For Immune Disorders 5/15/2025

    AGC Biologics, your friendly CDMO expert, today announced a partnership with Quell Therapeutics (“Quell”), a clinical-stage biotechnology company pioneering engineered T-regulatory (Treg) cell therapies.

  6. SK pharmteco Expands Stability Storage Capacity In California To Support Small Molecule Drug Substance And Drug Product Programs 5/15/2025

    SK pharmteco, a global contract development and manufacturing organization (CDMO), announces the expansion of its stability storage capacity at its El Dorado Hills, California facility.

  7. STEERLife Redefines Potent Drug Development With Clean, Green, Continuous Processing 5/15/2025

    STEERLife, the life sciences division of STEER World, is advancing the development and manufacturing of potent and complex drug products. This initiative marks a significant advancement in a field that has long been considered one of the most challenging areas within pharmaceutical science.

  8. Aldevron And Integrated DNA Technologies Manufacture World's First mRNA-Based Personalized CRISPR Therapy 5/15/2025

    Aldevron, a global leader in the production of DNA, RNA and protein, together with Integrated DNA Technologies (IDT), a global leader in genomics solutions, announced the successful manufacture of the world’s first personalized CRISPR gene editing drug product to treat an infant with urea cycle disorder (UCD).

  9. Tivic Health Enters GMP Manufacturing Validation Agreement With Scorpius BioManufacturing In Preparation For FDA Submission 5/14/2025

     Tivic Health Systems, Inc., a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing to complete the GMP manufacturing validation of the lead candidate from its TLR5 program, Entolimod, for treatment of Acute Radiation Syndrome, or ARS, in preparation for filing a Biological Licensing application, or BLA, with the U.S. Food & Drug Administration.

  10. 3PBIOVIAN Awarded At The CDMO Leadership Awards 2025 In The Cell & Gene Therapy International Category 5/14/2025