Stephen Ball explores the importance of particle size in biomedical nanotechnology. Experimental data are presented to illustrate how advanced DLS techniques deliver these measurements for colloidal gold in the nanosized and sub-nanosized ranges.
Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.
Jingjun (Jim) Huang, PhD, CEO, and Founder of Ascendia, discusses his company’s unique vision and strategy to provide pharmaceutical companies with a contract research partner that can provide technologies in order to efficiently determine which approach is most suitable for a given molecule.
STANDARDIZATION TECHNOLOGY – Innovative Temperature Standardization Technology Supports Cell Therapy Clinical Trials
Rolf O. Ehrhardt, MD, PhD, and Maria Thompson, PhD, discuss a unique proprietary temperature standardization technology that is practical for all stages of cell processing and handling. It is currently supporting a Phase IIb clinical trial investigating the efficacy of an immunotherapy treatment for patients with moderate-to-severe refractory Crohn’s disease.
DISSOLUTION ENHANCEMENT – Dissolution Enhancement Through Factorally Designed Porous Solid Dispersions
Balwan Singh and Harish Dureja, PhD, use mathematical models developed in their present study to predict cumulative percentage of glimepiride from PSDs. These models can then be utilized to formulate PSDs with desired glimepiride release.
Kaushik J. Dave, PhD, MBA, and Dragan Cicic, MD, MBA, indicate that alpha-particle emitters, such as bismuth-213 or actinium-225, may be more effective and efficient at killing cancerous cells not currently treated with radiation while simultaneously decreasing nonspecific cytotoxic effects.
Vijendra Nalamothu, PhD, reports that the importance of the right formulation and delivery method in topical pharmaceuticals is critical. It can mean the success or failure of drug substance, and getting the preparation right from the outset saves money and time.
Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.
FORMULATION DEVELOPMENT – Interactive Web Tool Helps Innovators Match Formulations to Drug Delivery Technologies
Kurt Nielsen, PhD, explains how an interactive web tool designed to help innovators match formulations to drug delivery challenges allows users to assess multiple oral drug delivery technologies in order to establish which may be the most appropriate for their molecule.
Marshall Crew, PhD, explores how the contract services and manufacturing market has responded to the opportunity presented by the rising numbers of BCS Type II/IV clinical compounds and solubilized commercial products.
EXCLUSIVE ONLINE CONTENT
Brickell Biotech Announces Final Patient Completed in First US Phase 3 Pivotal Clinical Study & Patient Enrollment Completed in Second US Phase 3 Pivotal Clinical Study
Brickell Biotech, Inc. recently announced the final patient has completed the Phase 3 pivotal Cardigan I study, and that all planned patients have been enrolled in the Phase 3 pivotal Cardigan II study…..
BioAegis Awarded BARDA Contract to Advance Development of a Novel Host-Directed Human Protein for Patients With Sepsis & Severe Infection
BioAegis Therapeutics Inc. recently announced it was awarded a contract from Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, to further….
Apellis Pharmaceuticals, Inc. and Beam Therapeutics Inc. recently announced an exclusive 5-year research collaboration focused on the use of Beam’s proprietary base editing technology to discover new….
Genedata recently announced that Encoded Therapeutics has chosen Genedata Bioprocess to digitalize their proprietary gene therapy R&D technology…..
Evonik offers an innovative green technology that enables the large-scale synthesis of active pharmaceutical ingredients in water. The “Chemistry in Water” technology has the potential….