Dosage Forms

Reshaping Dosage Forms

Advancements in personalized medicine and other innovations are transforming the way dosage forms are viewed.

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

Frontrunners in Bispecific Antibodies

Novel genetic engineering technologies are transforming the design and manufacture of bispecific antibodies, which are emerging as a promising new class of biologics.

FDA Adjusts Review Timeline to Keep Up with Orphan Drug Demand

July 18, 2016

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

Sandoz's Biosimilar to Enbrel Gets FDA Support Ahead of Panel

July 11, 2016

FDA reviewers have found that Sandoz's GP2015, a biosimilar version of Amgen's Enbrel, is highly similar to the original product in terms of purity, safety, and potency.

Federal Court Weighs in on Biosimilar Patent Dance

July 08, 2016

A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.

BioOutsource Launches IgG Glycosylation Tool

July 07, 2016

The assay will provide information on biosimilar comparability.

Novo Nordisk Expands Insulin Manufacturing Facility in Denmark

July 06, 2016

Novo Nordisk broke ground on an expanded production plant for insulin in Kalundborg, Denmark.

Teligent Breaks Ground on Manufacturing and R&D Expansion

July 06, 2016

Teligent is expanding its manufacturing and R&D complex in New Jersey.

Planning a Biologics Facility Start Up

July 02, 2016

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

Cleaning Bioreactors and Fermenters with CIP Systems

July 02, 2016

Early planning for the integration of clean-in-place systems for equipment cleaning is key.

Exploring the Use of Aseptic Spray Drying in the Manufacture of Biopharmaceutical Injectables

July 02, 2016

Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.

Survey Results Explores Biopharma Risk Model

July 01, 2016

A study by MilliporeSigma and the Economist Intelligence Unit reviews growth drivers and approaches to mitigate risk.