Dosage Forms

New manufacturing capacity at the Le Mans, France facility is being used to scale up antibody drug conjugates.

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

A global contract manufacturer of biologics discusses the increasing impact of health-based exposure limits in assessing cross-contamination risks.

What is a modular system and how are modular systems being used in the biopharmaceutical industry? Pär

Application of single-use technology in a parenteral facility for syringe filling.

An interview with Doug Hausner, C-SOPS, about continuous manufacturing

Draft guidance addresses the use of clinical pharmacology studies to determine biosimilarity of biologics.

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

The ionHP biodecontamination hydrogen peroxide-based sterilization technology is designed for use in aseptic enclosures.

The Manesty TPR 500 tablet press from Bosch Packaging Technology increases output and features a hygienic design.

New formulations and expanded vaccine production are encouraged.

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

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.

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.

Doug Hausner, Engineering Research Center for Structured Organic Particulate Systems, Rutgers University discusses continuous manufacturing for solid-dosage drug production.

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