Drug Development

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.

Contract development and manufacturing organizations identify trends, challenges, and emerging technology and service needs for solid and semi-solid dosage forms.

For a bio/pharma industry in flux, contract services are playing a greater-and more diverse-role in drug development.

Study provides first substantive reference data on key quality attributes of empty capsules

Hovione will use Merrion's GIPET absorption-enhancing technology for solid-dosage drugs.

Trifarma cited for significant deviations in data collection and security, and employee training.

The pharma industry is moving toward commercial-scale continuous processes for small-molecule API manufacturing.

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.