Drug Development

Paul Kippax is product manager at Malvern Instruments.

Jennifer Burt is applications specialist at Malvern Panalytical.

Carolyn O'Grady is UK applications manager at Malvern Panalytical.

Articles

This article examines IVBE testing requirements for topical creams and explores some of the analytical techniques necessary. 

Testing Topicals: Analytical Strategies for the In-Vitro Demonstration of Bioequivalence

Jon Lenn, PhD, is senior vice-president for MedPharm’s US operations. 

Marc Brown, PhD, is chief scientific officer and co-founder of MedPharm.

The human skin protects the body from physical, mechanical, and chemical insults while preventing endogenous water loss. This function is predominantly achieved by a thin (10–30 µm) cornified outermost layer-the stratum corneum (SC)-generated through terminal differentiation of the basal epidermal keratinocytes. The stratum corneum protects the human body, but also severely limits drug delivery into and across the skin.

A Perspective on the Topical Delivery of Macromolecules

Milind K. Biyani, PhD, is R&D consultant at Aspire Advisors Pvt. Ltd.

Thixotropic gels, thermosoftened systems, and self-emulsifying systems have expanded the range of potential excipients for liquid-filled hard capsules (LFHC).

Selecting Excipients for Liquid-Filled Hard Capsules

Jeff Williamson is director of Product Development at Lonza.

API-in-capsule approaches enable pharmaceutical companies to quickly assess new drug candidates with reduced API consumption and to increase speed to clinic.

Application of API-in-Capsule Best Practices to Accelerate Drug Product Development

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

Immobilizing the antibodies on a solid-phase support, such as a resin, and carrying out the conjugation of the payload-linker while the antibodies are bound to that support will prevent aggregation at its source.

Tackling Aggregation Challenges in ADC Production

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

Protagen Protein Services Expands Analytical Services for Biosimilar Development

The European Commission (EC) has approved Novartis’ chimeric antigen receptor T cell (CAR-T) cell therapy Kymriah for the treatment of B-cell acute lymphoblastic leukemia and relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

EC Approves Novartis’ Kymriah CAR-T Cell Therapy

Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.

bioLIVE Survey Ranks Top Bioprocessing Nations

The Coalition for Epidemic Preparedness Innovations (CEPI) and vaccine manufacturer IDT Biologika will collaborate to develop and manufacture a vaccine against Middle East Respiratory Syndrome Coronavirus (MERS-CoV).

CEPI, IDT Partner to Develop MERS Vaccine

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

Formulation and Drug Delivery