Formulation and Drug Delivery

Repligen Expands US Manufacturing Facility

March 03, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

A facility expansion adds space for production of Repligen’s tangential flow system.

Modest Expectations for CMOs and Biosimilars

March 03, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.

Industry Expert Q&A with Richard Grant

March 02, 2015

Richard Grant, Global VP of Cell Therapy at Invetech discusses the advantages and challenges of developing and manufacturing personalized immunotherapies.

The Global Biomanufacturing Outsourcing Market

March 02, 2015

The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.

Lyophilization Cycle Optimization of Cell-Derived Products

March 02, 2015

While the optimization of a lyophilization cycle for a biologic relies on a well-characterized formulation, viscosity and aggregation after product reconstitution must also be carefully managed.

Minimizing Risk during HPAPI Manufacture

March 02, 2015

Protecting workers, patients, and the environment requires advanced technologies.

Semi-Solid Dosage Forms

March 02, 2015

While the skin offers an alternative route of administration for local and systemic drug delivery, developing semi-solid dosage forms can be a challenge.

USP Publishes Monoclonal Antibody Guidelines

March 02, 2015

A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.

Considerations for personal protective equipment when handling cytotoxic drugs

March 02, 2015

It is vital that companies involved in the manufacturing and handling of cytotoxic drugs ensure that staff are given the highest possible levels of protection.

FDA Postpones Hearing for Remicade Biosimilar

February 27, 2015

FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.