Drug 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.

PolySciTech's new launch, SpinSwiper, has the potential to speed up microparticle production.

PharmSource special report shows demand for cytotoxic injectable drugs could tap existing CMO capacity.

Industry experts share their perspectives on key advances in controlled-release drug delivery and future innovations in this arena.

Transition metal-containing catalysts are widely used in organic synthesis, but many are based on expensive, rare metals. Researchers are seeking more sustainable alternatives.

DCAT's Sharp Sourcing 2014 educational program offers pharmaceutical and biopharmaceutical companies a forum to gain best practice insights in sourcing and procurement.

Appropriate process design and engineering are critical for the production of small-molecule and biologic HPAPIs.

The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.

Hospira has recalled one lot of labetalol hydrochloride injection, USP, due to visible particulates.

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

Industry experts discuss how extractables and leachables studies are designed using a risk-based approach.