Outsourcing

The inspection focused on fill/finish of ongoing commercial supplies of an adeno-associated virus viral vector biologics product for a major pharmaceutical client in the United States.

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

With 2025 now in full swing, this article presents a review of the latest developments in outsourcing services, new facilities, and M&A activity thus far this year.

Developers save money and time while accessing expertise.

The optimization of processes for the development and manufacture of biopharmaceuticals is pivotal for producing quality products.

The manufacturing agreement is expected to run through December 2030, subject to change, with production to take place at Samsung Biologics’ Songdo, South Korea, site.

Emerging therapies, patient-centric medicines, and the ever-changing world of bio/pharmaceuticals complicate technology transfer.

Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how process controls change during development through commercialization, how cell harvesting can be optimized, and which validation and/or qualification studies are performed for cell culture.

Contract development and manufacturing organizations (CDMOs) are more critical than ever as the demand for advanced therapies continues to grow.

Bob Schrock, PhD, senior director, global head of Process Development, at Lonza provides insight on how cell culture processes may be optimized and what kind of process studies are performed for cell culture.

The company has formed Scinai Bioservices Inc., new US-based subsidiary operating out of Delaware that will serve biotech companies in early stage drug development.

Daniel Giroux, VP of Biologics Development at Abzena, discusses approaches for optimizing process development for the production of proteins.

Lonza’s new tailored offering leverages the company’s bi-layer capsule manufacturing technology.

Modular and replication strategies are being utilized to meet growing demand for CDMO facilities.

The company officially launched new production suites, a revamp of its development labs, and more at its Thousand Oaks, Calif., cell therapy manufacturing facility.

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.

The new European facilities located in German, Italy, and Lithuania will specialize in drug discovery and R&D services.

Under a £15.7 million (US$20.7 million) investment, SEKISUI has expanded its UK site for clinical-grade drug substance manufacturing.

Frontage Laboratories' Marianna Tcherpakov, PhD, director of Business Development, CMC Services, discussed the CDMO’s role in enabling startup biotechs solve complex technical challenges for scale up.

Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.

Thermo Fisher Scientific's launch of its Accelerator Drug Development follows expansions of sites in Cincinnati, Ohio, and Bend, Ore., earlier in 2024 to enable R&D, manufacturing, and testing.

At this year's CPHI Milan, Camille Dumont, PhD, manager, customer applications, Lonza, discussed current industry trends that are impacting oral solid dose formulation work.

The annual survey predicts that four of the five biggest biologics capacity holders in 2028 will comprise CMOs, which will control 45% of all CMO capacity in Asia.

Cellevate's nanofiber microcarriers are the first on the market for use in manufacturing viral vectors used in gene therapy production, according to the company.