Formulation and Drug Delivery

Assembly Biosciences Reports Successful Clinical Study on Gemicel

December 09, 2015

Assembly Biosciences reported a successful clinical study validating the use of the Gemicel technology platform for the oral delivery of biologic medications.

EMA Accepts Sandoz’s Biosimilar for Etanercept

December 08, 2015

Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.

Seqirus Opens Corporate Headquarters in the United Kingdom

December 03, 2015

Seqirus, CSL Limited’s influenza vaccine business, announced the opening of their corporate headquarters in the United Kingdom.

Determining Biosimilarity

December 02, 2015

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes.

Fixed-Dose Combinations

December 02, 2015

The advantages of fixed-dose combinations are well recognized but their formulation and manufacture can be a challenge, Stefania Barzanti from IMA Active explains why.

GMP Challenges for Advanced Therapy Medicinal Products

December 02, 2015

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

Litigation and Manufacturing Hurdles Block US Biosimilars Market Success

December 02, 2015

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

Optimizing Semisolid Dosage Forms

December 02, 2015

Quality by design, in-vitro release testing, and modern analytical methods are improving understanding and control of these complex formulations.

EMA Guideline on Setting Health-Based Exposure Limits

December 02, 2015

The results of an industry workgroup’s examination of EMA’s guide on shared facilities are presented.

PTSM: Pharmaceutical Technology Sourcing and Management

Litigation and Manufacturing Hurdles Block US Biosimilars Market Success

December 02, 2015

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.