Formulation and Drug Delivery

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development.

Liquid formulations in hard-shell capsules or softgels are becoming a popular option for HPAPIs because of advantages such as improved safety and lower risk of potential exposure and product cross contamination.

The DF30Plus, a new version of Aptar Pharma’s aerosol metering valve for pressurized metered dose inhalers (pMDIs), incorporates an elastomeric cyclic-olefin-copolymer (COC) neck gasket.

Synthetic biology promises to drive tomorrow’s therapies, while continuous processing is already being used in some new drugs.

Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.

Recipharm has signed an agreement with Sweddish pharmaceutical company LIDDS for the production scale up and manufacture of LIDDS’ Liproca depot for the treatment of prostate cancer.

The aim of the collaboration is to advance the use of Cellectar’s phospholipid drug conjugate platform for targeted delivery of a selection of Pierre Fabre’s cytotoxics.

Synpromics announced collaborations with Avalanche Biotechnologies and Applied Genetic Technologies Corporation to use synthetic promoters to develop gene therapies, including adeno-associated virus technology for treating eye diseases.

Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.

Millipore Express PHF hydrophilic, sterilizing-grade filters from EMD Millipore offer faster flow rates to speed the process or reduce the process footprint.

Researchers from Oregon State University develop a new three-drug delivery system for cancer treatment.

PSL has installed several advanced contained filtration and drying facilities as part of an expansion of a pharmaceutical manufacturing plant in Singapore.

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

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

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

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

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.

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.

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.

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

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

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.