A wave of facility sales to CDMOs reflects shifting manufacturing strategies as drugmakers expand U.S. production and outsourcing partners scale capacity, the firm says.
The designation supports adoption of Cytiva’s adeno-associated virus manufacturing platform, designed to reduce encapsidated host cell DNA and improve process consistency.
The technology is designed to reduce variability and manufacturing costs associated with transient transfection-based adeno-associated virus production.
Renewed licensing agreement broadens access to off-the-shelf lentiviral plasmid systems designed to support CAR-T and other gene-modified cell therapy programs.
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.
The annual J.P. Morgan Healthcare Conference in San Francisco brought together executives who are positive about this year’s prospects for the sector.
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.
The new 2,000‑square‑meter quality control lab at its production facility in Hillerød, Denmark is designed to support the site’s bioreactor expansion.
Lilly’s total Chinese investment has reached nearly $6 billion, including $3 billion over the next decade to build a localized manufacturing and supply network.
