Robert A. Preti, PhD, discusses his company’s critical distinction from most other manufacturing partners, steady growth, and the primary challenges facing the cell therapy industry.
NON-CANNABIS THERAPY – Cannabinoid Therapy Without Using Cannabis: Direct Effects™ Topical β-Caryophyllene
Ronald Aung-Din, MD, in view of many documented medical benefits of cannabinoids, but with widely persisting regulations, misinformation, and stigma associated with cannabis, searches for a non-cannabis-derived source of cannabinoid therapy, such as found in β-Caryophyllene.
John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.
Peter G. Traber, MD, believes we are only at the beginning of understanding the full potential of gal-3 targeted therapy, and the future likely holds additional high affinity, specific, galectin inhibitors that are bioavailable by routes other than the two currently in development.
SPECIAL FEATURE – Formulation Development & Manufacturing – CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.
ELECTRONIC TONGUE INSTRUMENTATION – Improving the Palatability of User-Friendly Dosage Forms Using an Electronic Tongue
Detlev Haack, PhD, and Martin Koeberle, PhD, believe one exciting alternative starting to gain traction in the industry is assessment via an electronic tongue to detect and analyze all the compounds responsible for taste within a sample.
Gerald W. Crabtree, PhD, indicates drug or treatment delivery that employs microencapsulation, one of many promising developments in the field of regenerative medicine, offers not only treatments but also potential cures for a wide variety of maladies.
Dawn A. Firmin, MSc, PhD, explains how MGB has dedicated its focus to the development of a new class of small molecules, with specific antibacterial activity against susceptible and resistant bacteria.
EXECUTIVE INTERVIEW – Vetter: Establishing a Successful Clinical Fill & Finish Manufacturing Site for Biologics
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing the services of a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
ANTIMICROBIAL LIPIDS – Attenuating the Use of Medically Important Antimicrobial Drugs in Food-Producing Animals: What Role Can cGMP Lipids Play?
Ryan Littich, PhD, highlights some of the most significant, pathogen-borne diseases relevant to food-producing animals and reviews the antimicrobial properties intrinsic to midchain triglyceride lipolysis products.
EXCLUSIVE ONLINE CONTENT
Scioto Biosciences recently announced the closing of a strategic investment of up to $26.5 million from Genome & Company and other investors to join in an upcoming tranche….
Protalix BioTherapeutics & Chiesi Global Rare Diseases Announce US FDA Acceptance of Biologics License Application
Protalix BioTherapeutics, Inc. together with its development and commercialization partner Chiesi Global Rare Diseases recently announced the US FDA has accepted the Biologics License Application (BLA) and granted….
MyoKardia, Inc. and LianBio recently announced they have entered into a strategic collaboration to develop and commercialize….
GigaGen Announces Publication of Research Describing a New Class of Drugs, Recombinant Hyperimmunes, Including its Novel COVID-19 Therapy, GIGA-2050
GigaGen presents a novel technology for producing a new class of drug, which it calls recombinant hyperimmunes…..
Biogen Inc. and Denali Therapeutics Inc. recently announced they have signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for….