Formulation Development
CONTROLLED RELEASE – Leveraging Precision Particle Fabrication® Technology to Create Patient-Friendly Dosage Forms
Cory Berkland, PhD, and Nathan Dormer, PhD, review how controlled-release powders offer a flexible and efficient approach to addressing a multitude of patient populations, while also improving compliance.
GALECTIN-DIRECTED THERAPIES – Targeting Galectin-3 Protein in Drug Development
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.
MARKET BRIEF – Preferences for Targeted Therapies & Patient-Centric Approaches Drive Transformations in Oncology Drug Delivery Market
Frost & Sullivan Analyst Piyush Bansal says although chemotherapy has been successfully used for inhibiting cell growth throughout the past few decades, the side effects of chemotherapy have forced researchers to look for some alternative drugs (and how to effectively deliver them) for all types of cancer.
EXECUTIVE INTERVIEW – PCT: Manufacturing the Future of Cell Therapies
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.
ASSAY VALIDATION – Biomarker Assay Validations – A Time for Change?
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.
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.
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.
ANTIMICROBIAL RESISTANCE – MGB: The Minor Groove Binder
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.
EXCLUSIVE ONLINE CONTENT
Intravacc & Primrose Bio Announce Partnership to Enhance Conjugate Vaccine Development
The companies will leverage their combined experience in the development of conjugate vaccines for their clients….
Abzena Announces Major Investment in Bioconjugation & ADC Capabilities in Response to Increasing Industry Demand
Abzena recently announced a significant expansion of their Bristol, PA bioconjugate development and cGMP manufacturing site. The $5-million investment in expanded laboratory….
Vector Pharma & Oncopeptides FZCO Announce Collaboration to Provide Pepaxti to Patients in the Middle East & North Africa
Oncopeptides AB and Vector Pharma FZCO recently announced a collaboration to commercialize Oncopeptides’ flagship drug Pepaxti (melphalan flufenamide) in the Middle….
Vaccinex Announces $1.5-Million Registered Direct Offering & Concurrent Private Placement Priced At-the-Market Under Nasdaq Rules
Vaccinex, Inc. recently announced it has entered into definitive agreements with certain institutional investors for the purchase and sale of 193,000 shares of its common stock in a….
Teva UK & Closed Loop Medicine Announce Strategic Partnership to Advance Development of Personalized Medicines
Teva UK Limited and Closed Loop Medicine Ltd have announced a strategic partnership to advance the development of personalized medicine. Under the agreement, Closed Loop Medicine and Teva UK will investigate….
WEBINARS
WEBINAR – 2024 Trends in Topical Drug Delivery: Insights & Innovation
This webinar will discuss some of the key trends from these leaders in the topical market on both a global and regional level, including the increased importance of sensory properties and the rise in non-conventional product formats, among others…..
WEBINAR – Enabling Upstream Intensified Bioprocessing
Intensified upstream bioprocesses are being developed to increase productivity while reducing footprint, costs, and timelines for manufacturing. The higher cell densities generated by….
WEBINAR – Nanoparticle Suspensions: History, Applications & CMC Aspects
This webinar describes the history, CMC aspects, and potential applications of nanoparticle suspensions (NSs). This drug delivery technology should be considered for crystalline, sparingly water-soluble APIs. The presentation highlights….
WEBINAR – Impact of Process Re-design on Sustainability in Pharmaceutical Small Molecule Manufacturing
Join us for an upcoming webinar that delves into a crucial issue in the pharmaceutical industry. Recent research has revealed a surprising fact: the pharmaceutical sector has a larger carbon footprint than even the automotive industry, especially when we consider the entire supply chain’s impact on
WEBINAR – Beyond the Lab: Unleashing the Potential of In Silico Modeling in Drug Product Formulation
In this webinar you will learn how digital chemistry tools facilitate rapid screening of formulation parameters, aiding in the identification of optimal drug delivery systems, excipient selection, and dosage forms….
WHITE PAPERS
WHITEPAPER – Manufacturing of 10-mg Loratadine Self-Emulsifying Drug Delivery System (SEDDS) Tablets by Direct Compression With ABISORB-DC & ABISOL Emulsion Preconcentrate Kit
10-mg loratadine SEDDS were successfully manufactured with ABISORB-DC(TM) and ABISOL(TM) 2 by direct compression on a rotary tablet press, employing standard pharmaceutical manufacturing equipment…..
WHITEPAPER – Revolutionizing Small Molecule API Production: Unveiling the Impact of Fermentation as a Sustainable Solution
While large molecules continue to advance in drug development pipelines, small molecule Active Pharmaceutical Ingredients (APIs) still retain their historical dominance among new drug applications…
WHITEPAPER – Copolymer Microstructures: Connecting Monomer Sequence Distribution With Biomedical End-Application Performance
To gain insights into advanced copolymer characterization techniques and their impact on drug release in biomedical products, we invite you to explore the latest Corbion white paper…..
WHITEPAPER – Monitoring Low Dose API Blend Uniformity With Parteck® M Mannitol Using Near-Infrared (NIR) Spectroscopy
Direct compression is often used for tablet manufacturing because it is the shortest, most effective, and least complex method. The physical properties of active pharmaceutical…
WHITEPAPER – The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein Formulation
This white paper evaluates the viscosity-reducing capacities of excipients and excipient combinations…..