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

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

Articles

While the United States and Europe still dominate, CMOs and CROs based in emerging markets continue to capture market share.

Biomanufacturing Outsourcing Globalization Continues

Doug Kirsch is Technical Service Manager at Natoli Engineering Company. www.natoli.com

Adjusting the tablet press and its systems can prevent manufacturing and product quality problems.

Fixing Tableting Problems

Stephen Wicks, PhD, is the scientific regulatory policy and intelligence officer of the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe, Stephen.WICKS@edqm.eu. EDQM is a leading organization that protects public health and amongst other things is responsible for the European Pharmacopoeia.

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Ensuring the Quality of Biologicals

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

Mylan Recalls Injectables Due to Visible Particulate Matter

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

FDA Releases Final Biosimilar Guidance

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

Catalent Awarded Vaccine Research Grant

The agency has recommended granting marketing authorization for Opdivo.

EMA Recommends Authorization of Melanoma Treatment

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

Dicerna Receives Orphan Drug Designation for PH1 Treatment

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

Biosimilars May Spur Improvements in Reference Product Manufacturing Processes

A presentation by Jim Miller will offer a detailed review of the contract services landscape.