Drug Development

With nanomedicines on the rise, a new class of non-biological complex drugs (NBCDs), which include nanosimilars, has emerged. As drug regulators are faced with the challenge of defining a framework to ensure the safe introduction of the follow-on nano-therapeutics, Stefan Muhlebach explains why NBCDs cannot be assessed using the standard generic or biosimilar approaches.

The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.

Drug formulators are looking for new excipients to address solubility and bioavailability issues and extend patent protection, but there are hurdles to using novel, specialized ingredients.

CMOs may find opportunities in alternative expression services.

Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.

Automated sample handling, advanced glycan analysis, and specially designed columns are help speed up confirmation of the biosimilarity.

Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.

Traditional project decision-making is compared with a QbD approach.

The relatively low success rates for bio/pharmaceutical compounds in clinical development have prompted many organizations to explore ways of reducing risk in clinical development.

BASF receives EXCiPACT Certification for the group of polyvinylpyrrolidone polymers, produced in Germany.

Avantor Performance Materials adds VWR International locations to its certified excipient distributor program.

Products enable testing in accordance with methods described in new USP monograph.

FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location

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.