Drug Development

Safer fluorinating reagents and access to GMP fluorination capabilities remain challenges in API synthesis.

With a quality-by-design approach, robust processes can help deliver quality product consistently.

Formulation will utilize Catalent?s OSDrC OptiDose multicore drug-delivery platform.

DuPont Nutrition & Health has added a new pharmaceutical excipient to the portfolio of ingredients for CPhI Worldwide 2014, in Paris this October.

Understanding how to identify, remediate, and prevent facility infection is crucial for product quality.

Molecular Profiles has expanded its capsule filling capability following significant investment into new equipment at its clinical manufacturing site in the United Kingdom.

Conventional tablets may no longer be the go-to solution.

A survey of the recent literature reveals numerous advances in asymmetric chemocatalysis.

The quality-by-design principles used to control process variability are equally important to measurement systems because process variability includes contributions from measurement system variability. The authors use real-life examples from drug development projects to outline how an understanding of chromatographic measurement system variability might be achieved.

With a quality-by-design approach, robust processes consistently can help deliver quality product.

Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.

The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.

Changing regulations are impacting the identification and monitoring of variable materials in excipients.

New excipients and improvements to existing excipients are needed to facilitate access to new drugs for patients.

The quality and composition of excipients can vary due to environmental factors, processing methods, raw material quality, manufacturing location changes, and even operator actions.

Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.

API development and manufacturing companies expanded their capabilities, built partnerships, and achieved milestones in regulatory inspections.

Customers are looking to reduce risk, increase performance, and optimize productivity.

Annual study shows CMO technical expertise is not enough.

Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.

Hovione announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by FDA.

Quality by design, process analytical technology, and high throughput screening have helped drive progress in pharmaceutical development.

Quality by Design has initiated a paradigm shift in solid dose pharmaceutical manufacturing.

The EXCiPACT Certification Scheme ensures patient safety through supplier quality while minimising the audit burden and overall costs for assessing the excipient supply chain.

Contract research, development, and manufacturing organizations invested in new facilities and technologies in 2014 for analytical testing, as well as small- and large-molecule drug development.

Contract service providers describe how quality by design has influenced a drug sponsor's expectations of suppliers.

Representatives of contract service organizations that develop biologic-based drugs discussed technology trends such as high-throughput screening and single-use systems.

Experts from contract testing laboratories and service organizations shared their perceptions of analytical testing advances, and challenges still ahead.

Representatives of contract service organizations that specialize in parenteral drug development and manufacturing describe the evolving trends.

Despite the growth of specialist companies with capabilities across various therapeutic areas in Europe, there is still a need for early development expertise with end-to-end pharmaceutical manufacturing capabilities.