Bioavailability & Solubility
Paulo Lino, PhD, and João Henriques discuss the main development goals and present a framework for a streamlined development of amorphous solid dispersion formulations by spray drying.
FORMULATION FORUM – Revitalization of Older Drug Products Using Innovative Formulation Technologies by 505(b)(2) Regulatory Pathway
Jim Huang, PhD, says more than 50% of approved drugs on the market contain poorly water soluble APIs, which typically are associated with poor bioavailability, suboptimal drug delivery, ineffective drug efficacy, and side effects, and this creates a huge opportunity in generating 505(b)(2) products.
Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release delivery.
SPECIAL FEATURE – Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
Jim Huang, PhD, and Edward Orton, PhD, say it is critically important CROs or CDMOs that support discovery and preclinical research have the requisite preformulation, formulation, and biopharmaceutics expertise as well as the proprietary methodologies to develop formulations from small quantities of drug candidates for different routes of administration.
Jim Huang, PhD, discusses how a sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.
DRUG DELIVERY – Targeted Delivery of Submicron Particle Cancer Chemotherapy: Helping Shift the Immunotherapy Paradigm
Marc A. Iacobucci says that with much attention and research investment into IOT, NanOlogy is shaping a new paradigm for cancer treatment by attempting to improve the safety and effectiveness of tried and true CT through local delivery.
David S. Johnson, PhD, provides a unique insight into immune dysregulation through a proprietary technology known as Surge – a platform that quickly characterizes every cell in complex immune systems so that natural immune repertoires can be translated into medical treatments.
Joel Tune, MBA, says for those peptide therapeutics that meet the necessary criteria, advances in formulation technologies coupled with favorable market dynamics will continue to drive interest across the entire prescription drug spectrum for safe and effective orally administered peptide therapeutics.
PERSONALIZED IMMUNOTHERAPY – Off-the-Shelf Personalized Immunotherapy for Breast Cancer: The BriaCell Solution
William V. Williams, MD, Markus Lacher, PhD, and Charles L. Wiseman, MD, explain how there is a clear need for ways to stimulate effective cancer-specific immune responses while avoiding time-consuming and costly individualized manufacturing.
EXCLUSIVE ONLINE CONTENT
TxCell SA and Lonza Pharma & Biotech recently announced entering into a Master Service Agreement for the manufacture of TxCell’s HLA-A2 CAR-Treg cellular product (TX200), which is in development for the prevention of chronic rejection after organ transplantation.
EXECUTIVE INTERVIEW – Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.