Manufacturing

Increased pharmaceutical trade creates new challenges for regulatory oversight.

A new method of vaccine design, called the Multiple Antigen Presentation System (MAPS), may result in vaccines that bring together the benefits of whole-cell and acellular or defined subunit vaccination.

Australian team develops method for making ultrafine particles for more efficient drug delivery.

Susan Schniepp, vice-president of quality and regulatory affairs at Allergy Laboratories and co-chair of the program planning committee for the 2013 PDA/FDA Joint Regulatory Conference, discusses quality systems and related considerations in parenteral drug manufacturing.

FDA conducted a general inspection of operations and quality systems of Albany Molecular Research Inc (AMRI) in Burlington, Mass.

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.

New cartridges designed specifically for use on high-speed filling lines increase efficiency.

Presenters at a pharmaceutical extrusion seminar discussed formulating drugs produced using hot-melt extrusion.

Containers, components, and quality control equipment help safeguard product quality and patient safety.

The authors describe how a combination of imaging techniques can be used to provide topographic and chemical information to characterize a sample.

Vetter has ready-to-submit documentation for this service in Common Technical Document (CTD) formats for the US, Europe and Japan.

The new ink takes less a second to dry and is four times more fade resistant than inks that are typically used in retail packaging.

The US and EU move forward with measures to fortify the pharmaceutical supply chain.

Report outlines recommended practices for control and evaluation of operations.

Novartis and Biological E, a biopharmaceutical company based in India, have entered into an agreement that aims to deliver affordable and accessible vaccines for typhoid and paratyphoid A fevers to developing countries and thereby address the unmet medical need in endemic regions.

Compounding, tracking legislation moves forward

Risk management guides decisions in facility design and operation for highly potent drugs.

A screening method aligned with USP 1660 guidance predicts glass delamination in primary packaging for parenterals.

Contract service providers expand capabilities in API and finished product manufacturing to meet demand for high-potency drugs.

The author presents best practices for extractables and leachables.

GE Healthcare's partnerships with iBio and Brazil's Bio-Manguinhos/Fiocruz for a new plant-based multipurpose biopharmaceutical and vaccine manufacturing facility move plant-based protein production to the next level.

The US and EU move forward with measures to fortify the pharmaceutical supply chain.

Greater sophistication in 3D X-ray imaging technology raises its utility for QA/QC in manufacturing.

The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.

Combination product design takes second prize in the National Collegiate Inventors and Innovators Alliance Biomedical Engineering contest.