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Ocugen Announces FDA Clearance of IND Amendment to Initiate Phase 3 Clinical Trial - First Gene Therapy to Enter Phase 3 With a Broad Retinitis Pigmentosa Indication April 8, 2024
Ocugen, Inc. recently announced the US FDA has cleared the company’s Investigational New Drug (IND) amendment to initiate a Phase...Merck Animal Health to Acquire Elanco’s Aqua Business February 5, 2024
Bolsters Merck Animal Health’s position in the aqua industry with comprehensive approach to ensure fish health, welfare and sustainability in aquaculture, conservation and fisheries….
FORMULATION FORUM - Lipid Nanoparticles – Carriers for Nucleic Acids Delivery January 26, 2024
Shaukat Ali, PhD, and Jim Huang, PhD, describe the role of individual components in aggregation, packing, stability, efficacy, and potency of nucleic acids, the understanding of which is important to achieve better designed and smarter formulations, and robust scale up and manufacturing of LNPs.
GDMC Secures $21-Million Growth Capital Funding to Expand Global Genetic Medicines Design & Manufacturing Operations January 25, 2024
Genetic Design and Manufacturing Corporation (GDMC) recently announced a Series A funding of $21 million. The funding round is led...ReciBioPharm Partners With Acuitas Therapeutics to Provide Rapid Technology Transfers & cGMP Manufacture of LNP Formulations December 12, 2023
ReciBioPharm, the advanced and emerging therapies business unit within Recipharm, and biotechnology firm Acuitas Therapeutics have recently announced they are taking their partnership to the next level….
KBI Biopharma Expands Global Portfolio With Launch of SUREmAb for Faster Monoclonal Antibody Development & Manufacturing September 12, 2023
KBI Biopharma, Inc., a JSR Life Sciences company, recently announced the launch of SUREmAb, an offering built on the robustness...IMMUNOLOGY - Innovation Gathers Momentum Amid New Scientific & Technological Breakthroughs May 1, 2023
Patrick Larcier, PhD, says research is entering a new era in immunology with treatments for pathologies that previously had few or no options and looks at the latest trends and what is on the horizon for 2023 and beyond.
EXECUTIVE INTERVIEW - Ascendia Pharmaceuticals: Innovative Solutions to Challenging Problems May 1, 2023
Jim Huang, PhD, CEO and Founder of Ascendia Pharmaceuticals, discusses how his company expanded its people, capabilities, and facilities to meet and exceed customer expectations from early to late-state development and how this investment allows Ascendia to continue be an expert in sophisticated formulations, as well as cGMP sterile and non-sterile clinical trial and commercial manufacturing.
VACCINE TECHNOLOGY - Solving the Challenges & Introducing New Strategies for Influenza & COVID-19 Protection May 1, 2023
Paul Radspinner, MBA, and Pamuk Bilsel, PhD, say with a combination vaccination strategy, the biopharma industry could truly solve the efficacy, durability, and drift problems of current influenza and COVID-19 vaccines.
Aldevron Announces Expansion of mRNA Production Capability May 1, 2023
Aldevron recently announced it will expand its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities enabling...Bhami Research Laboratory & Catalent Enter Licensing Agreement for Technology to Deliver High-Concentration Biologics Subcutaneously March 16, 2023
Bhami Research Laboratory (BRL) and Catalent recently announced a licensing agreement that will provide Catalent with access to BRL’s formulation...Catalent to Expand Its Biologics Analytical Services With New Facility in North Carolina December 14, 2022
Catalent recently announced it is to establish a new biologics analytical center of excellence in Durham, within North Carolina’s Research...Exelixis & Catalent Enter New License Agreement for Three Antibody-Drug Conjugate Programs With the Potential to Accelerate Exelixis’ Biologics Pipeline November 3, 2022
Exelixis, Inc. and Catalent, Inc. recently announced a new license agreement under which Catalent’s Redwood Bioscience subsidiary will grant Exelixis an exclusive license to three target programs with….
Catalent Expands Biologics Analytical Capabilities With New Laboratories at Center of Excellence in Kansas City, MO October 20, 2022
Catalent recently announced a $12-million expansion program to increase biologics CGMP analytical capabilities at its flagship facility in Kansas City,...EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics October 3, 2022
David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
EXECUTIVE INTERVIEW - BIOVECTRA: mRNA & the Future of Pharma June 1, 2022
Marc Sauer, PhD, discusses his new position, growth at BIOVECTRA, and how he believes mRNA technologies can best be leveraged to improve the lives of patients.
EXECUTIVE INTERVIEW - Catalent: Developing & Delivering Billions of Doses of Drugs Every Year June 1, 2022
Alessandro Maselli, President and Chief Operating Officer of Catalent, talks about his company’s unique approach to drug development partnerships as he prepares to become the company’s new President and Chief Executive Officer on July 1, 2022.
CELL & GENE THERAPY - State of the Industry – Where is C> Headed? April 5, 2022
Bill Vincent believes if the industry wants to keep moving up the steep growth curve, then capacity and raw materials must be readily available. The innovations in therapies, platforms, and processes will all come with time, money, and increasing availability of resources.
Allergy Therapeutics Selects AGC Biologics to Manufacture Novel Peanut Allergy Vaccine Candidate March 31, 2022
AGC Biologics recently announced a new partnership with Allergy Therapeutics, the fully integrated specialty pharmaceutical company specializing in allergy vaccines. The...
