Outsourcing

For successful drug delivery partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

New drug approval policies promote industry growth and injectable contract manufacturing opportunities in China.

Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.

Adopting best practices and collaborating more closely with contract research organizations can help drugs get past Phase III.

Biopharmaceutical contractors continue to invest in development, facility upgrades, technological advancement, and mergers and acquisitions.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

The new company is the product of a merger with Formex.

Uncertainty about the demand for a biologic medication can be partly mollified with some well-planned capacity outsourcing, contends a new report by ORC International sponsored by Patheon.

Acquisition binges often lead to hangovers; here’s what to watch out for.

Advances in single-use systems, consumables, and continuous manufacturing show steady progress.

BioPharm sat down with an intellectual property lawyer to examine how companies are protected when they engage in activities where sharing of trade secrets must occur.

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

Investment at SGS’s Mississauga, Canada facility provides for analysis of molecular interactions in real time.

Growth may be slowing, but outsourcing activity remains healthy.

Pfizer announced the launch of Pfizer CentreOne, a CMO formed by the combination of Pfizer CentreSource and Hospira One 2 One.

The authors investigate the sufficiency of high-temperature short-time treatment in inactivate mouse minute virus contamination.

Careful planning, adequate staffing levels, and experienced project managers can help avoid pitfalls of transferring processes from one facility to another.

Demand is driving expansion and consolidation of formulation and clinical trial materials services.

Contract biopharmaceutical manufacturing has been growing steadily and is expected to reach $4.1 billion by 2019.

Collaboration will provide for unified development and manufacture of antibody drug conjugates.

The biopharmaceutical outsourcing market starts 2016 with company expansions, acquisitions, and new offerings.

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.

The authors provide their perspectives on shipping validation.

3M Drug Delivery Systems, Ei Solutionworks, IDT Biologika join CMO/CDMO association

Heightened global uncertainty could slow bio/pharma development activity.

Industry experts discuss what the outsourcing market holds for 2016.

AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.

Grand River Aseptic Manufacturing expands disposable technology capabilities at aseptic facility.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.