Drug Development

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.

The authors evaluated a variety of materials of construction (MOCs) and found that visible residue limits (VRLs) were higher on some MOCs than on stainless steel. The optimal viewing conditions were dependent on the MOC and the viewing background. The risk of a cleaning failure due to visual failure for different MOCs can be mitigated or eliminated using complementary cleaning validation studies.

Through its educational and networking opportunities, the American Association of Pharmaceutical Scientists plays an important role in partnering throughout the drug- development and commercialization process.

Researchers from the University of Bradford, UK, have developed a solvent-free, continuous method to manufacture the more soluble and bioavailable form of artemisinin. The metastable form produced using high-temperature extrusion has been shown to have greater stability and longer shelf-life.

Cedarburg Hauser Pharmaceuticals has upgraded its API plant in Wisconsin.

J&J's Janssen and PATH partner to improve drug formulation that could help prevent HIV infection.

Molecular Profiles has secured a major pan-European formulation project, in which the company will be responsible for developing a topical and an oral formulation for Telormedix's psoriasis products, TMX-302.

Pfizer advances its pipeline of antibody-based therapies using a host cell line that combines engineered glycosylation technology and enhanced gene-expression.

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

Unilife grants Sanofi long-term exclusivity for the use of Unilife?s prefilled syringe with Sanofi?s Lovenox.

FDA updates guidance to reflect advances in technology.

New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.