Manufacturing

This article reviews factors that affect protein stability at different steps of the product manufacturing process and strategies to minimize their impact on product quality.

Removal of microorganisms is crucial when working with biologics. Sterile filtration offers a reliable, safe, and effective way to ensure product integrity.

Meritech’s CleanTech 2000SCA Automated Handwashing System delivers a 12-second wash and rinse cycle that removes 99.98% of dangerous pathogens from bare skin and gloves.

Hamilton’s EasyFerm Bio biocompatible pH sensor is designed for CIP, sterilization up to 140 °C, autoclavable temperature, and a pressure range up to 6bar.

Experts attending the European Psychiatry Association Congress in Vienna say that Adasuve has made an impact in the treatment of agitation in patients suffering from schizophrenia or bipolar I disorder.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Medicago's new production facility will make plant-based vaccines and therapeutics.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

Alexion will construct a biologics facility in Ireland that is its first outside the US.

Pall has agreed to be acquired by Danaher for $127.20 per share.

Pluristem Therapeutics announces that Japan’s Pharmaceuticals and Medical Devices Agency agreed with its methods for the manufacture of PLX-PAD cells.

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

Meissner’s single-use biocontainer, FlexGro, is designed for use with rocker-style bioreactors.

Higher cell densities, greater demand for high-performance viral clearance, and desire for large-scale single-use technologies are driving development of filtration technologies.

Choosing the optimal protein expression vector depends on strain, promoter, and a number of other factors.

Manufacturer supply chain needs are changing in response to widening product temperature ranges.

The costs and benefits of integrating modular concepts for on-demand bioprocessing are explored.

Integrating advances in facility design can meet differing and emerging bioprocessing needs.

The biopharma industry has had some successes but still needs to work on operational issues.

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

Agency teams work together to encourage manufacturers to seek approval for previously unapproved drugs.

Baxter voluntarily recalls select lots of IV solutions due to possible particulate matter.

Facilities in China, Ireland, Germany, and the United States have been recognized by ISPE in the 2015 Facility of the Year Awards program.