Drug Development

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

EMA hosted a workshop on Nov. 26, 2013, which brought together regulators, health-technology-assessment (HTA) bodies and the pharmaceutical industry to discuss how to generate evidence in drug development and improve medicines access.

In this sponsored podcast, Adam Stuart, Senior Design Engineer at 3M Drug Delivery Systems, discusses the role of dose counters for metered dose inhalers and the technical challenges companies can face when adding this feature to their inhaler products.

Unilife to begin commercial supply in 2014.

Covance Inc. and Pathoquest have announced a collaboration to provide next-generation sequencing (NGS) based biosafety assessments to detect and identify viral contaminants within biologic compounds.

New interactive web tool helps innovators match formulations to drug delivery technologies.

Merck Millipore has introduced a new solubility/bioavailability enhancement excipient, Parteck SLC, which has a unique pore structure that enables higher loading of amorphous APIs, thereby, improving dissolution rates and increasing drug solubility.

EMA and FDA publish joint QbD guidance on design space verification.

Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.

Predicting long-term storage stability of a given protein and formulation is desirable for effective screening and optimization early in the development process. Multiple routes to aggregation during storage to suggest that multiple measurement types should be made to probe different aspects of protein behavior.

Data from BioPlan Associates’ 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

The benefits of solvent-free processes and techniques specifically optimized for coating new dosage forms such as orally disintegrating granules are reviewed.

Pharmaceutical companies have long recognized the need to protect their market position long before their products come off patent. Pharmaceutical Technology spoke to Neal Hansen, managing director of the consulting firm, Hansen Strategy, about key considerations in product lifecycle management

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

Combined service offers drug development companies efficiencies in time and resource.

Recent news and developments from CPhI of excipient producers, CDMOs, and CMOs are highlighted.

Excipients market will be shaped by greater supply-chain concerns, quality-by-design programs,and overall drug-safety issues.

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs.

The success of Adcetris and Kadcyla is paving the way for more antibody drug conjugates to enter the market, especially in the treatment of solid tumors.

Capacity expansions and new products meet needs for inhaler and injector systems.

With the enforcement of the European Directive 2011/62/EU relating to medicinal products for human use regarding falsified medicinal products, new requirements are introduced for active substances. The new regulation requires among other things, documentation of the supply chain traceability.

On-demand drug release has the potential to reduce the side effects associated with the over-dosage of drugs, particularly for highly potent anti-cancer therapies.

3M Drug Delivery will manufacture transdermal patch for ProStrakan.

Formulation and process considerations for ethyl cellulose aqueous dispersion in sustained-release applications.

Kurt Lumsden, Director Client Services at Perceptive Informatics, a subsidiary of PAREXEL, discusses regulatory requirements for the drug accountability process.