Drug Development

Articles

The author discusses how x-ray spectrometry can be an effective way to measure these impurities and meet regulatory guidelines.

Meeting USP Guidelines for Elemental Impurity Analysis with X-ray Fluorescence Spectrometry

The author discusses key process parameters and shows how a process optimization template can be used to improve this key operation.

Optimizing Tablet Compression

Irwin Silverstein, PhD, is vice-president and chief operating officer at International Pharmaceutical Excipients Auditing, 1655 N. Fort Myer Drive, Suite 700, Arlington, VA 22209, tel. 703.351.5266.

The author discusses key areas of focus and presents best practices from the International Pharmaceutical Excipients Council (IPEC).

Excipient Quality and Selection

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

Designing a Biomanufacturing Facility Incorporating Single-Use Technologies

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

Kite Pharma Stresses Importance of Cell-Culturing Techniques

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.

Outsourcing Formulation Development for High-Potency Compounds

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

Manufacturing of antibody drug conjugates requires high-containment solutions, such as high-performance aseptic isolators.

Best Practices for Handling Antibody Drug Conjugates

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

FDA Releases Online Course on Biosimilars

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

Vaccines Prove Effective and Cost-Effective

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

Formulation and Drug Delivery