Outsourcing

The complexities of tech transfer may be overcome by data-driven approaches, digital tools, and effective communication.

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel.

The company will be expanding its quality control testing capabilities at its San Diego, Calif. biologics development and manufacturing site.

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

Pharmaceutical Technology Europe chats with Kevin Li, MBA, from BioDuro-Sundia about integrated services and the benefits these services can provide to pharma companies.

According to the annual survey, four of the five biggest biologics capacity holders in 2028 will comprise CMOs, which are expected to have 45% of all CMO capacity in Asia.

The nanofiber microcarriers are the first of their kind for manufacturing viral vectors used in gene therapy production, according to Cellevate.

Contract organizations offer assistance for testing raw materials obtained from outside suppliers.

As part of a range of sustainable products and services that SGD Pharma plans to showcase at CPHI Milan, the company will introduce its siliconized molded glass vials.

According to the survey results, 49% of industry respondents are “highly positive” on the contract services sector seeing growth over the next 18 months.

Lonza signed a long-term supply agreement to manufacture CASGEVY (exagamglogene autotemcel) for Vertex at its facility in Geleen, the Netherlands, and plans to expand manufacturing to Portsmouth, NH, in the United States.

Contract organizations offer assistance when managing changes to material suppliers during a product’s lifecycle.

Qualifying material suppliers is a crucial step in ensuring safe and effective drug products.

Rentschler Biopharma has expanded its service offerings at its Stevenage, UK, site with a new lentiviral vector manufacturing toolbox.

Employing novel technologies and more patient-centric approaches can help to reduce the potential of formulation failure.

Contract organizations offer sponsors specialized equipment, capacity, and expertise for testing, manufacturing, and packaging bio/pharmaceutical products.

The addition of BIOVECTRA’s biologics capabilities to accelerate drug development and manufacturing will allow Agilent to expand its end-to-end offerings for biopharma services.

PluriCDMO, Pluri's newly launched CDMO division, has been selected by Kadimastem to manufacture two novel cell therapy product candidates.

Thermo Fisher will add Olink to its Life Sciences Solutions business.

HCPs are major process-related impurities that must be monitored throughout biologics production for clearance.

This collaboration aims to support and accelerate clinical development of advanced and novel technologies.

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

The pairing of Abzena and Argonaut Manufacturing Services is the result of several years’ worth of collaborative work between the two companies.

CordenPharma has partnered with Spain-based Certest to develop ionizable lipids for LNP formulations.

The PharmTech Group spoke with BIOVECTRA's director of Business Development, Nucleic Acid Modalities, Jessica Madigan, about the concept of flexibility in outsourcing and the 2024 BIO Convention.

Asking why things are done a certain way will help make an accurate assessment of an organization’s EM program, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates, and Zachary S. Anderson, global market segment lead—Sterility Assurance, Nelson Laboratories.

Sterling is strengthening its development and manufacturing services for ADCs with a dedicated GMP suite at its Wisconsin facility.

The company’s new division will provide end-to-end integrated discovery services.

The partnership aims to provide end-to-end development and manufacturing for biopharmaceutical drug substance and drug product.

With this acquisition, Merck KGaA will have the capability to offer integrated services for viral vector manufacturing.