Manufacturing

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Successful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance.

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.

Clearly defined zones of cleanliness must be designed and maintained to prevent product contamination.

Safer reagents and reaction conditions are making many hazardous transformations possible.

PAT holds the key to real-time quality assurance and consistent product quality in pharmaceutical manufacturing.

Pharmaceutical Technology spoke to experts in the field of biopharmaceutical manufacturing to gain insights on top trends that are currently shaping the industry.

Careful choice of wash-water parameters and attention to water quality and basket loading are important for optimal cleaning.

Hosokawa Micron’s Mini Cyclomix lab mixer is designed to blend formulations for dry-powder inhalers without deteriorating the particles.

Ross’ Multi-Shaft Mixers with interchangeable mixing vessels include an optional cover featuring propeller blades.

Thermo Scientific’s Spinnaker Smart Laboratory Robot, featuring Thermo Scientific Momentum 4 software, is designed to eliminate the need for manual correction of drift by automatically compensating for positional variations.

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

ProMetic Life Sciences will use manufacturing and plasma fractionation processes at Emergent BioSolutions’ Winnipeg, Canada facility.

Grand River Aseptic Manufacturing named one of Michigan 50 Companies to watch.

Gyrolab CHO-HCP Kit 1 detects and quantifies host cell proteins from Chinese hamster ovary cells.

Despite the buzz about biologic-based drugs, small molecule-based drugs are still the mainstay treatment.

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Senior Editor Agnes Shanley reviews key points pharma companies should address to meet global requirements for pharma supply chain safety. Hear how pharma companies can address the concerns such as drug counterfeiting, adulteration, and drug shortages.

The countdown has begun for one of the biggest trade shows for the process industry.

While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

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

Appropriate feeding equipment can be selected to meet the challenges of dosing powders that are sticky or do not flow well.

Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet.