Outsourcing

Communication and taking the time to develop the process are key to successful transfer and scale up of biologics

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

The outlook for the CMO and CDMO industry may be affected by ever-changing politics.

SGS invested in test equipment for analyzing extractables and leachables at its New Jersey laboratory.

Vetter expanded visual inspection facilities and controlled-temperature storage at its Ravensburg Vetter West facility in Germany.

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Biosimilars may be the key to CMO growth.

The company expanded its commercial packaging facility in response to a growing demand for pediatric drugs.

Avecia is adding drug substance capacity at its Milford, MA manufacturing site.

The new Boston laboratory offers advanced analytical testing services.

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.

CMO executives are focusing on M&A activity, new business models, and fundraising limits.

Catalent invests $34 million to add a 2 x 2000-L single-use bioreactor system and laboratory space in Madison, WI.

The authors describe the qualification of an assay with applications for investigating functional comparability of an originator and biosimilar drug.

Challenging molecules and markets are driving the development of new solutions for drug delivery.

This key bioprocessing segment is expecting continued growth.

The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

CMOs are working hard to improve performance by investigating new technologies for filtration and purification.

GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.

EAG Laboratories announces new company identity and intent to expand testing, analysis, and characterization capabilities across multiple markets.

Patheon launches initial public offering to repay outstanding notes and expenses.

CDMOs need to be aware that unfavorable public markets put emerging bio/pharma R&D spending at risk in 2017.

Capacity for complex therapeutics is become increasingly difficult to predict.

Technology advances enable contract service providers to keep pace with the demands of existing and emerging biologic-based therapies.

Contract service providers debate the pros and cons of consolidation, accelerated drug approvals, regulatory issues, and the impact of new therapies.

Planning ahead is key to enabling a continuous and secure supply chain that adapts to changes in market demand.

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.