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

Reshaping Dosage Forms

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

Development of Taste-Masked Oral Dispersible Tablets of Cefpodoxime Proxetil

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

Frontrunners in Bispecific Antibodies

Topic

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Articles

Follow-on biologics or biosimilars offer a niche growth market for the pharmaceutical industry. As the process for establishing a regulatory pathway for biosimilars is debated, companies, including Big Pharma, are positioning themselves to gain this piece of the pharmaceutical pie.

Gauging Opportunities in the Biosimilars Market

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi,  Tel. +91.9650770650, asrathore@biotechcmz.com.

The number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.

Upcoming technologies to facilitate more efficient biologics manufacturing

The authors examine common superdisintegrants (i.e., crospovidone Type A, crospovidone Type B, croscarmellose sodium, and sodium starch glycolate) with a set of poorly soluble drug actives and evaluate in vitro drug dissolution.

Influence of Superdisintegrants on the Rate of Drug Dissolution from Oral Solid Dosage Forms

A bipartisan bill that would establish a regulatory pathway for the approval of biosimilars was introduced into the US House of Representatives last week.

Bipartisan Bill for Biosimiliars and Biogenerics Introduced in the House

The spotlight on the biopharmaceutical industry is intensifying, as recently evidenced by Pfizer's (New York) ongoing acquisition of Wyeth (Madison, NJ), which was initiated partly to reduce the former's dependence on small-molecule drugs.

The Shape of Biopharmaceutical Facilities to Come

The authors extend the range of a near-infrared calibration model for tablet assay using production 'seed' spectra and synthetic spectra generated from placebos and 'pure' active pharmaceutical ingredient spectra.

Extending Calibrations for Near Infrared Assay of Tablets Using Synthetic Modeling and Variance from Placebos

Michiel Ultee talks about the challenges involved in transferring technology to a CMO and why communication is so important.

Facilitating technology transfer to your CMO

The productivity of the pharma industry has been declining for several years. Could biotechnology reinvigorate drug development?

Building on the promise of biotech

PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

PAT: HPLC on the horizon?

After two years of hearings, more than 5000 pages of expert testimonies, and 939 medical articles, a special federal court ruled that there was little, if any, evidence to support the claim that substances in the measles, mumps, and rubella vaccine (including the use of thimerosal) had led to the autism of three children.