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

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GE Healthcare’s GE BioPark Cork will hold four KUBio manufacturing facilities; GE will also collaborate with NIBRT for biopharmaceutical training.

GE Healthcare Invests in Ireland Biopharma Manufacturing Campus

3M™ Intelligent Control Inhaler

The project aims to address challenges facing the development, manufacture, and delivery of vaccines.

Merck KGaA Joins the DiViNe Project

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.

Biosimilars Face Repercussions of Drug Pricing Debate

director of Scientific Writing and Regulatory Affairs at Sciformix Corporation

If FDA’s proposed generic-drug labeling rule is passed in 2017, generic drug companies would need documented processes for safety tracking and label updates.

FDA’s Proposed Generic-Drug Labeling Rule: Ensuring Efficiency and Compliance

Rong-Kun Chang, PhD, is associate director at Supernus Pharmaceuticals.

Susan Rosencrance, PhD is with the Center for Drug Evaluation and Research, FDA

Andre Raw, PhD is with the Center for Drug Evaluation and Research, FDA

Bing Cai, PhD, is acting director, Division of Liquid-Based Products at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Pahala Simamora is acting branch chief, Division of Liquid-Based Products at FDA’s Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research.

Companies may potentially accelerate the approval of generic drugs by avoiding deficiencies in ANDA submissions.

Common Deficiencies in ANDAs for Dermatologic Drug Products

Gretchen L. Shearer, PhD, is a senior research chemist at McCrone Associates and an instructor at Hooke College of Applied Sciences, Westmont, IL. gshearer@mccrone.com.

Visual inspection of parenteral vials is the first step in a root cause investigation.

Taking a Closer Look at Parenteral Contaminants

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.

Aptar Pharma Forms Pact with BD to Develop Novel Autoinjector

Ajay Pazhayattil*, M.Pharm, DBA, Ajay.Pazhayattil@capcium.com, is vice-president, Scientific and Regulatory Affairs at Capcium.

Flexible batch sizes for semi-continuous unit operations, such as tableting and encapsulation, can improve efficiency while maintaining quality.

Determining Minimum Batch Size

David Smith is CMO manager at Glide Pharmaceutical Technologies Ltd.

Alex Lyness is an enterprise fellow at Loughborough University, Healthcare Engineering Group, Centre for Biological Engineering, Wolfson School of Mechanical and Manufacturing Engineering,Loughborough University, Leicestershire, UK.

David Grant is technical lead, new technologies, david.grant@glide-technologies.com.

Scott Constable is principal project co-ordinator, QuotientMetabolism at Quotient Bioresearch (Rushden) Ltd.,Northamptonshire, UK.

Johannah Sharman is regulatory affairs manager at KalvistaPharmaceuticals Ltd.

A study demonstrates the feasibility of a novel solid-dose formulation injection technology to effectively deliver a therapeutic treatment without the aid of a needle.