Laurie L. Sullivan and John Bergin, MS, MBA, BCC Research Analysts, indicate that NGS has matured into an essential life science tool for genetic studies in a range of applications, and the industry is on the cusp of a second growth phase, powered by new applications in clinical diagnostics.
Robert C. Getts, PhD, and Jessica Bowers review how the 3DNA platform is composed entirely of noncoding DNA assembled through the sequential hybridization of single strands of DNA into a network of double-stranded nucleic acid having a controlled architecture, and multiple attachment sites for drug and targeting molecules.
Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.
Contributor Cindy H. Dubin recently spoke with several companies that are debunking the theory that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating innovative platforms.
Wetteny Joseph, President of Clinical Supply Services at Catalent Pharma Solutions, discusses the changing nature of clinical trials and the supply of materials for studies, and how Catalent is investing in new solutions, systems, and facilities to assist the biopharmaceutical industry.
Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc., discusses his success in building futures with his clients and more importantly, the lessons he’s learned along the way.
Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.
ORALLY DISINTEGRATING TABLETS – Designed With Patients in Mind: The Art of Patient-Centric Drug Formulation
Anthony Recupero, PhD, believes by partnering with an expert in drug delivery technology, whose portfolio features a broad range of proprietary technologies, pharmaceutical companies have the potential to add further value to their products and extend market exclusivity.
Tom Reynolds, PhD, Matt Wessel, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD, report that computational methods, such as QM and MD simulations, are playing an ever-expanding role in drug discovery and development, and transforming advances in drug development at all stages.
Kathryn A. Lee, PhD; Markus Lankers, PhD; and Oliver Valet, PhD, discuss various aspects with regard to microscopic particle counting, sizing, and identification using Raman, laser-induced breakdown, and IR spectroscopies, and how these techniques can help accurately identify particles.
EXCLUSIVE ONLINE CONTENT
Crown Bioscience recently announced the launch of a new tumor organoid drug development platform with the potential to significantly improve the……
White Paper: Control of Beta-Glucans & Endotoxin in High Purity Sucrose for Biopharmaceutical Applications
This white paper discusses a Quality by Design (QbD) scenario that allows end users to rationally select the well characterized excipients during biopharmaceutical development and develop a control strategy for biologic drug products.
White Paper: High Purity Low Endotoxin Arginine: Applications in Biopharmaceutical Processing & Biotherapeutic Stabilization
This white paper discusses arginine, also known as L-arginine (symbol Arg or R), a basic amino acid widely used in biopharmaceutical processing and stabilization of biotherapeutics.
Pfenex Inc. recently announced the US FDA has approved the new drug application (NDA) for PF708 submitted under the 505(b)(2) regulatory pathway, with…
To facilitate the demand for this new world order, we’ve unveiled the Accenture INTIENT Clinical platform. It helps companies run faster clinical trials with better transparency and….