Dosage Forms

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

The authors describe how modular systems can be applied to continuous solid-dosage and nutraceutical manufacturing.

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.

FDA develops an assay that could speed the release of pandemic influenza vaccines.

Dalton Pharma completes its $2.5 million expansion in Toronto for sterile and aseptic filling capabilities.

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

Higher antibody titers and a growing demand for smaller-volume, flexible processes are creating the need for more cost-effective downstream processing.

Catalent Pharma Solutions recently launched several new softgel product developments, all of which solve a delivery problem, while offering IP advantages to drug manufacturers.

Crystal Pharmatech selects Freeslate for its CM Protege PharmD System.

Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.

Aesica has successfully completed the validation of its high capacity manufacturing facility in Queenborough, UK, for commercial production. The

HHS plan makes progress in ensuring availability of safe vaccines.

Quality-by-design principles enhance a thorough understanding of both product and process technology, which is needed for optimization of solid-dosage manufacturing, including processes for improving solubility, such as hot-melt extrusion, softgels, and liquid-filled capsules.

Capsule filler

Speedy Filler Produces 200,000 capsules/hr

Tablet Press

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.

A survey on postapproval CMC changes was conducted to better understand reporting categories, nature and risks, and review outcomes.

Tablet Press with Fastest-in-Class Changeover

Discovery of split and broken tablets led to drug recalls.

Moody's Investor Service reports AbbVie, Amgen, and Roche are the most exposed to biosimilar competition.

EMA releases an update on its flu vaccine guidance.

Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

BioOutsource will open a new Biosimilar Center of Excellence in Scotland.

PDA works with FDA to create pharmaceutical quality metrics.

CMOs may find opportunities in alternative expression services.

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