Drug Development

CPhI-InformEx Report will to describe American pharma economy from European and domestic perspectives.

NMR analysis provides crucial structural information of synthesized glycans while LC-MS/MS is ideal for quantitation of free sugars in biological matrices.

Antibody fragments pose unique challenges in terms of recovery, purification, and formulation.

Emerging markets are an engine for growth in the custom-manufacturing and pharma markets.

A collaborative pharmaceutical project to develop paediatric formulations using smart design and predictive science has received the go ahead after securing a ?660,000 grant from UK-based Technology Strategy Board.

CMC Biologics and OnoSynergy form an agreement from cell-line development.

BioWa and Lonza have entered into a licensing agreement with MedImmune for cell line technology.

FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.

Researchers at Massachusetts recently reported on the development of a drug-eluting contact lens designed to provide prolonged delivery of the glaucoma medication, latanoprost.

EMA revises its polices on fee reductions for orphan drugs for 2014.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

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.