Dosage Forms
Establishing Limits for Dermal Absorption of Elemental Impurities
September 02, 2015
Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.
Industry Expert Q&A with Robin M. Silva
September 02, 2015
Industry Expert Q&A with Robin M. Silva, Partner, Morgan, Lewis, and Bockius LLP
Biocontainer Assemblies Provide Repeatable Performance
September 02, 2015
Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.
Quality by Design in Solid-Dosage Manufacturing
September 02, 2015
QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.
Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry
September 01, 2015
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.
Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020
August 28, 2015
Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.
FDA Releases Guidance on Biosimilar Nomenclature, Requests Comments on Interchangeable Product Naming
August 27, 2015
In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.
Cell Culture, Single Use, and the Evolving Biopharmaceutical Landscape
August 24, 2015
Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.
Key Considerations in Excipients Selection for Solid Dosage Forms
August 24, 2015
Randy Wald, senior research fellow at Bend Research, part of Capsugel Dosage Form Solutions shares insights on trends shaping the evolving solid dosage manufacturing landscape, including advances in excipients and the impact on formulation development and manufacturing processes.
Elizabeth Scheu & Kniss Partners with Carlisle Precision Machining to Supply Capsule-Filling Machine Replacement Parts
August 20, 2015
Elizabeth Scheu & Kniss will supply replacement parts for Bosch capsule filling machines.