Drug Development

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

The success of a pharmaceutical manufacturing transfer from one facility to another requires detailed operational plans, attention to detail, and coordination between all parties. \

Bio/pharmaceutical contract service provides continue to invest in development, facility upgrades, technological advancement, and mergers and acquisitions.

Multiple methods are required for detecting and removing protein impurities.

A new era has begun to address the deadly innovation gap in tackling the antimicrobial resistance crisis.

The therapeutic candidate AZD8601is an investigational mRNA-based therapy that will be tested for its ability to regulate the protein that influences vascular tissue growth.

A new website collects and rates information about life-science supplies from academic journals to simplify researcher purchasing decisions.

The antisense drug will be the first in the companies’ joint development deal for medications to treat autoimmune disorders of the gastrointestinal tract.

FDA issued a warning letter to the Worthing, UK facility for cross contamination and microbial contamination cGMP violations.

The agency says the increasing requests for orphan drug designation has resulted in a change in FDA’s review goals.

A new study examines the oral delivery of protein drugs in plant cells and hypothesizes that the cold storage and transportation of biologics could someday be eliminated.

This new method uses inter-alpha inhibitors to promote attachment and long-term growth in stem cells.

Integrating quality and compliance with technology transfer and careful project management are key in starting up a facility and launching a biologic drug.

CPhI Pharma Awards seek nominations for excellence in development and manufacturing.

Recent chiral advances demonstrate promise for API synthesis.

Polymers have played a key role as solubilizing excipients. Industry experts explain why polymer structures and functionalities are important considerations in formulation development.

Lipid-based drug delivery is increasingly being used to tackle oral bioavailability challenges resulting from poor solubility.

Aseptic spray drying provides an alternative to lyophilization as an enabling stabilization technology for parenteral biologic formulations.

The Titan syringe pump from Syrris is a continuous-flow chemical processing module designed for lab, pilot, and production-scale applications.

Hovione expands drug substance and HPAPI capacity in East Windsor, New Jersey.

Pharmaceutical Technology sat down with Charles N. Kettler, PhD, director of Natoli Scientific, to discuss the Natoli Institute for Industrial Pharmacy at Long Island University.

Effective harvesting and purification processes play an essential role in ensuring that biopharmaceutical manufacturing processes provide biologic drug substances with uniform and consistent properties.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

The collaboration will provide GMP manufacturing ahead of future clinical studies.

A new 20,000-L microbial biologics facility in Ireland will be operational by 2018 for Fujifilm Diosynth's contract development and manufacturing customers.