Drug Development

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.

Once an afterthought, packaging has now become an essential component of biopharmaceutical product development and marketing.

With the rising threat of antibiotic resistance and a diminishing R&D pipeline for novel drugs, Europe must step up its game to address this growing problem.

Drug developers are taking a wait-and-see approach to the use of cocrystals.

Biopharma companies should not overlook India's growing market.

Laser Diffraction Software Supports Analytical QbD

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.

Experts share insights on how product appearance such as size, shape, color, and imprint can make a difference in reducing medication errors.

Lifecycle management opportunities are impacting the development of controlled-release technologies for solid-dosage drugs.

The author discusses various aspects of the hot-melt extrusion process and outlines a practical approach to scale-up.

Charlie Martin, Leistritz Extrusion, describes hot-melt extrusion manufacturing processes and advances.

The author examines the effect of compaction force, gap width, and sieve setup on granule size.

A study investigated the influence and correlation of critical process parameters for the optimization of in-process curing.

The selection of excipients is important in generic formulations due to the impact it has on the risk and performance of generic drugs.

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

The international pharmaceutical industry is changing its approach to R&D and is increasingly relying on outsourcing for drug discovery.

Kurt Lumsden, Director, eCDS Client Services at PAREXEL Informatics, discusses eClinical supply-chain management.

Mark D. Kramer talks about combination products from a regulatory perspective and explains the implications of FDA's final rule on current GMP requirements for combination products.

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

Anil Kane from Patheon spoke to Pharmaceutical Technology about the challenges in the development of FDCs and discussed how to integrate quality-by-design (QbD) in the manufacturing process of FDCs.