Drug Development

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

Unilife grants Sanofi long-term exclusivity for the use of Unilife?s prefilled syringe with Sanofi?s Lovenox.

FDA updates guidance to reflect advances in technology.

New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

The new subcutaneous formulation of Herceptin can be administered six times faster than the standard intravenous formulation.

Are strategic partnerships in clinical research a model for CMC services?

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs

The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.

Developments involve stereoretentive cross-coupling, enantioselective alcohol silylation, strategies for amplifying signals in circular dichroism spectroscopy, and a synthetic route for the natural product ingenol.

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

Commercial-scale amide formation and an improved process route for a tetracycline derivative are some recent developments in API synthesis.

Case studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.

Industry experts share perspectives on risk assessment and mitigation in excipient manufacture and the excipient supply chain.

Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.

Reversible nanoencapsulation technology may make it possible to deliver high molecular weight drugs directly to target cancer cells, increasing efficacy and reducing side effects.

Agencies collaborate to ensure consistent product quality.

CDER withdraws some outdated guidance documents and makes plans to finalize others.

Rapid screening of critical API properties can quickly identify the best approach for increasing bioavailability.

A simple, rapid analytical method for the determination of palladium in pharmaceutical production samples will speed up development and optimization of reactions involving palladium catalysts.

The companies initially focused on five biosimilar products.

Adamis Pharmaceuticals agrees to license and potentially acquire 3M's Taper Dry Powder Inhaler technology.

Stapled peptides offer promise to enable cell permeability, binding to therapeutic targets, and modulation of biological pathways.

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.