Under the agreement, the Switzerland-headquartered CDMO will acquire AmbioPharm’s two manufacturing facilities in North Augusta, South Carolina and Shanghai, China.
The collaboration links expression system development with GMP manufacturing to reduce scale-up risk and cut three to six months from early-stage program timelines.
The drug substance facility certification follows approval of the company’s fill-finish site in February, completing GMP coverage for end-to-end dengue vaccine production.
The program will leverage the CDMO’s microbial manufacturing network across its Heidelberg, Germany and Chiba, Japan facilities for clinical trial supply.
The agreement supports a $260 million national vaccine localization initiative, with SK bioscience’s varicella vaccine selected as the initial product for tech transfer.
Audit readiness in pharmaceutical manufacturing isn’t just about documentation—it’s built into the physical condition of your facility every day. This webinar reveals how proactive...
Join this session to learn how life sciences manufacturers are leveraging advanced flow measurement insights to improve reliability, maintain compliance, and deliver confidence...
Big Pharma and contract development and manufacturing organizations are making large capital expenditures to build infrastructure supporting the wildly popular medications.
Industrializing the manufacturing of these complex therapies is critical to ensure scalability and commercial viability, says the Alliance for Regenerative Medicine.
Large pharmaceutical companies have promised to invest more than $370 billion over the next five years in the U.S., driven by Trump’s threat of pharma-specific tariffs.
The proposal also includes $9 million and 19 new full-time positions for the U.S. Food and Drug Administration to accelerate advanced pharmaceutical manufacturing.
To counter the Chinese government’s investment, the U.S. must make a coordinated effort to grow biomanufacturing base, argues a bipartisan commission created by Congress.
The pharma giant has added to its inventory of orforglipron in anticipation of a favorable regulatory decision by the U.S. Food and Drug Administration.
Raleigh-Cary and Durham-Chapel Hill secured the first and third spots, respectively, as the nation’s most competitive markets for the production of therapeutic biologics.
Faced with the increasing complexity of peptide programs, Japan’s drugmakers are turning to outsourcing in preclinical and early stages, contends Neuland Laboratories.
The framework for the development and approval of individualized therapies for genetic conditions has significant chemistry, manufacturing, and controls hurdles.
AI is helping life sciences manufacturers improve uptime, PM effectiveness, calibration planning, and reliability analysis. See where practical AI adds value in GMP asset management...
Software platforms can seamlessly integrate with emerging technologies to unlock efficiencies, strengthen sustainability and enable proactive prevention of disruptions.
Built-in ability to meet data integrity standards should be a central focus when selecting control systems and manufacturing execution systems for pharma manufacturing
The pilot, which launched in April, has evaluated 46 facilities using one-day inspectional assessments as the agency looks to make its resources more targeted and efficient.
The agency cited the CDMO’s significant violations of current Good Manufacturing Practice regulations for finished pharmaceuticals at Simtra’s Halle/Westfalen facility.
The agency issued a Complete Response Letter for Incyte’s supplemental Biologics License Application, citing inspection findings at Novo Nordisk’s fill-finish facility.
