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

Partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA, 19107, tel: 215.985.0400, www.jacobswyper.com.

Articles

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.

Generating Savings from Room Declassification

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

Cleaning a Vial Filling Line

Andrew Teasdale, PhD, is a Principle Scientist at AstraZeneca.

Katherine Ulman is a Global Regulatory Compliance Manager at Dow Corning.

Phyllis Walsh is a senior compendial manager at Schering-Plough Corporation in Kenilworth, New Jersey.

EHS specialist at Dow Corning Corporation, Auburn, MI

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

Establishing Limits for Dermal Absorption of Elemental Impurities

Industry Expert Q&A with Robin M. Silva, Partner, Morgan, Lewis, and Bockius LLP

Industry Expert Q&A with Robin M. Silva

Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.

Biocontainer Assemblies Provide Repeatable Performance

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

Quality by Design in Solid-Dosage Manufacturing

Geoffrey Wu, PhD*, is a regulatory review officer, geoffrey.wu@fda.hhs.gov.

Lane Christensen, PhD, is a chemist at FDA, CDER’s Office of Generic Drugs.

Thomas O’Connor is chemical engineer, science staff at the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

Frank Holcombe Jr., PhD is with the Center for Drug Evaluation and Research, FDA

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

Kristina Adams, PhD is with the Center for Drug Evaluation and Research, FDA

Xiaochuan Yang, PhD is with the Center for Drug Evaluation and Research, FDA

Min Li, PhD is with the Center for Drug Evaluation and Research, FDA

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020

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

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

FDA Releases Guidance on Biosimilar Nomenclature, Requests Comments on Interchangeable Product Naming

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.