Biologics APIs

Ultra high performance liquid chromatography is advantageous in a contract laboratory because it is faster, more sensitive, and relies on smaller volumes of organic solvents than HPLC.

Michigan State University researchers have discovered a technique for viewing whole cells to gain an understanding of protein inclusion bodies.

The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

A book about pharmaceutical analysis engages the reader with history and unexpected asides.

A well-balanced guide to industrial bioseparations provides valuable information.

Molecules called "chaperones" facilitate correct protein folding.

The authors describe the critical aspects of an ideal fermentation services provider.

Pharmaceutical companies developing new drug candidates for Hepatitis C virus infection now can test their compounds with a novel culture system that mimics the biology of HCV infection in humans.

Drugmakers seeking to block the activity of a protein may have a new strategy at their disposal.

Antibody drug conjugates offer a niche opportunity in drug development and contract manufacturing.

Creating a kinder, gentler manufacturing process that doesn't kill the product is the goal of process developers doing large-scale cell culture for cell therapy.

Nanoparticle-based systems present many advantages for the delivery of current and emerging biological drugs.

Polyplus-transfection, a company that researches, develops, and commercializes drug-delivery solutions for biomolecules, created a new technology designed to enhance in vivo delivery of small interfering RNAs (siRNAs) when they are associated with a cationic polymer.

What makes a drug ripe for respiratory delivery?

Scientists at The Wistar Institute are taking further steps into understanding a gene regulator that can lead them closer to developing new cancer therapies.

An updated book summarizes recent research for formulators and drug-delivery specialists.

A surge in capacity in contract microbial and mammalian cell-culture is underway to meet rising production needs for biopharmaceuticals.

The authors review methods for reducing analysis time and increasing throughput that are reliable and maintain data integrity.

Polysaccharide-based chiral stationary phases have been developed that comprise chiral selectors immobilized on their support rather than being physically coated. These materials are completely solvent stable, thereby increasing selectivity and and enabling the development of new chiral selectors that have been too unstable in a coated form for general use.

The combination of supercritical fluid chromatography with chiral separation media offers several analytival advantages over traditional liquid chromatography techniques.

Ultrahigh pressure liquid chromatography maximizes efficiency, but, as defined by the resolution equation, the stationary phase is still a crucial consideration when attempting to resolve mixtures of compounds.

High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.

Reflecting strong growth prospects for certain biologic-based drugs, the biotechnology and pharmaceutical majors are proceeding with a strategy of expanding their internal manufacturing networks and partnering with select contract manufacturing organizations (CMOs).

Pharmaceutical Science & Technology Innovations

One of the greatest challenges facing biopharmaceutical manufacturers has been the primary recovery of recombinant materials from transgenic sources. As an alternative to existing methods, vibrating membrane technology, which is widely used in food and beverage processing, recently has been adapted to biopharmaceutical applications involving transgenic biosolutions.

Pharmaceutical science & technology news.

USP ensures the microbiological quality of products by way of the development, proposal, and acceptance of general information chapters.