Formulation and Drug Delivery

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.

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.

Xcelodose provides automated processing of API directly into capsules at low doses. The expansion of Xcelodose reinforces Juniper’s early stage capsule filling capability.CDMO Juniper Pharma Services, a subsidiary of Juniper Pharmaceuticals, announced that it has expanded its Xcelodose powder micro-dosing system. This move reinforces the company’s early stage capsule filling capability.

While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

A study backed by the Centre of Regenerative Medicine found that laminins are crucial cell components that could help aid the commercial production of stem cell therapies.

Text from a merger prospectus reveals the termination fee for the proposed Pfizer-Allergan deal would change if any new tax regulations were passed prior to the closing of the transaction.

The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.

BioOutsource releases informational video detailing issues associated with ADCC assays and how to effectively analyze them.

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.

Almac is investing GBP16 million to expand its formulation and analytical development services and has successfully negotiated to operate in the Charnwood Campus in Loughborough, England.

Even though rising production and use of generic pharmaceuticals is saving billions for the nation’s healthcare system, policy makers continue to slap the industry with policies it claims will limit product development and sales.