Formulation and Drug Delivery

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.

Celltrion Launches Remicade Biosimilar in European Markets

February 25, 2015

Remsima will now be available for patients in 12 additional countries in the European Union.

Biological Safety Cabinets Contain Hazardous Drug Powders

February 25, 2015

Enclosures contain powders and particulates during hazardous drug manipulation.

BMS Furthers its Immuno-Oncology Pipeline with Nearly $1.6 Billion in Investments

February 23, 2015

Bristol-Myers Squibb announced that it reached an agreement to acquire Flexus Biosciences and has entered into a $309-million partnership with Rigel Pharmaceuticals.