Outsourcing

Access to multiple analytical techniques is essential for fully characterizing complex protein formulations.

Early adopters are benefiting from lower costs and increased productivity.

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Developments and investments in single-use systems advance upstream biomanufacturing.

Outsourcing analytics can be a cost-effective way for biopharma companies to adapt to new technologies and regulations.

The contract research organization has added a new analytical laboratory in Middleton, WI, to expand its biologics testing capacity.

The agreement gives IncoCell Tianjin, a wholly-owned subsidiary of China-based Boyalife Group, access to Cesca’s celluar processing contract development and manufacturing services.

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.

The company plans to install 4000-L disposable bioreactors from ABEC at its new commercial manufacturing facility in Wuxi city, China.

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.

The contract development and manufacturing organization has expanded biologics capacity at its facility in Berkeley, CA.

The new 73,000-square-foot facility is one of several expansions to support the company’s biologics testing capabilities.

Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.

A review of the latest investments in facilities, equipment, and acquisitions by biopharma contract service providers.

A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.

Successful outsourcing relationships for early phase analytics in drug development are driven by partnership.

Research suggests that working with a single contract partner can reduce development time and improve economics.

Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.

Catalent completes $4.6 million expansion at Singapore clinical supply facility and marks 20 years in the region.

Development and adoption of new technologies create challenges that may take years to resolve.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

The company aims to add the additional analytical services in the European Union throughout 2018.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

Unlike current approaches where bioconjugation is typically done following the manufacture of the monoclonal antibody and the cytotoxic drug, the new method begins with the antibody supernatants and eliminates the need for extensive chromatographic purification.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

The companies have been awarded a collaborative grant of £1.9 million (US$2.6 million) from Innovate UK.

Biopharm industry veteran Ralf Otto named to lead development and manufacturing at Rentschler Biopharma.

Layout and supply details must be considered when implementing a fully disposable biopharmaceutical manufacturing process.

Frustrated with high costs and drug shortages, hospitals adopt a DIY approach.

Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.