Formulation Development
EXTRACELLULAR VESICLES – Engineering Extracellular Vesicles to Create Next-Generation Therapeutics
David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.
MEDICAL DEVICE TESTING – Chemical Characterization & the Non-Targeted Analysis of Medical Devices
Luminita Moraru, MSC, MRSC, says the medical devices industry is in continuous growth, and the development of new reliable and accurate approaches in order to assess the safety of the products should constantly be reviewed.
EXCIPIENT COMPACTION STUDY – Developing a Reliable Controlled-Release Polymer Using a Compaction Simulator
Gopeshkumar Singh, MS, and Ajit Bhagat provide study results showing that through polymer chemistry, it is viable to effectively manufacture matrix tablets via a simple direct compression method; and Hypromellose has impressive compatibility at various compression forces.
DRUG DISCOVERY – Getting the Most From a DNA-Encoded Library Screen
Matthew A. Clark, PhD, says despite this high level of interest, there remains variable understanding of how to maximize the potential of a DEL screen, and shares his company’s approach to DEL screening and how its partners get the most from this powerful technology.
PLATFORM TECHNOLOGY – The Evolution of Cancer Vaccines: Moving Beyond Failure & a New Era for Cancer Treatment
Jeremy R. Graff, PhD, says new studies show promising data with the use of mRNA-based vaccines and the injection of nanoparticles into regional lymph nodes to achieve disease stabilization. This has led to a potentially groundbreaking era of therapeutic cancer vaccines thanks to discoveries in identifying truncal targets, targeting tumor neoantigens and, notably, developing improved delivery technologies that stimulate a robust, targeted, and persistent immune response.
NANOPARTICLE ENGINEERING – Lighting the Way to a Patient-Centric Future
Christopher Worrall, PhD, discusses how nanoparticle engineering technologies could help improve compliance and patient outcomes, for both small-molecule and biological drugs, and how nanotechnology can help facilitate a shift toward more patient-centric medicine.
TOP SPRAY GRANULATION – POLYOX™: Producing Lightweight Metformin Hydrochloride Extended-Release Tablets for Patient Adherence & Cost-Effective Manufacturing
Atul Lohade, PhD, Vinay Muley, and Tejas Gunjikar, PhD, explain how understanding the challenges associated with developing smaller extended-release tablets, and the excipient-based solutions to these challenges, will empower formulators to develop robust, stable drug formulations with high patient adherence while cutting manufacturing costs.
ON-DEMAND WEBINAR – CMC Strategy to Take Bispecifics From DNA to IND in 13 Months* by Lonza
Lonza has applied it’s 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This presentation….
WHITEPAPER – Extrusion-Spheronization, Engineered for Today’s Controlled Release Forms
Synchronizing and controlling API delivery, extrusion-spheronization (E-S) offers pharmaceutical companies a robust technique to manufacture today’s most complex therapeutics.
WHITEPAPER – Launching a Drug-Device Combination: 5 Key Factors to Focus On
Going to market in a delivery device is one of the most complex steps in the life cycle of an injectable medication. A CDMO expert explains where to start and what to prepare for.
EXCLUSIVE ONLINE CONTENT
BC Platforms & NTT Group Announce Official Opening Ceremony for Exclusive Collaboration & Launch of Japanese Precision Medicine Platform
BC Platforms (BCP) recently announces an exclusive collaboration with NTT Life Science Corporation, a company in the medical field of the NTT Group, to accelerate data-driven….
Naobios & Sumagen Sign Exclusive Partnership to Develop HIV Vaccine
Naobios will manage process development and initiate launch of cGMP manufacturing for Phase 2 clinical trials….
NovelMed Receives FDA Orphan Drug Designation for Treating Paroxysmal Nocturnal Hemoglobinuria; Seeks Partnership
NovelMed recently announced the US FDA has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment….
Asahi Kasei Bioprocess & Axolabs Announce Strategic Partnership to Accelerate Oligonucleotide Therapeutics Development
Asahi Kasei Bioprocess (AKB), part of the Asahi Kasei Group, and Axolabs have recently announced a strategic partnership in the burgeoning field of oligonucleotide….
Arvinas Enters Transaction With Novartis, Including Global License Agreement for the Development & Commercialization of Androgen Receptor Protein Degrader
Partnership expected to accelerate and broaden the development of ARV-766 as a potential first-in-class treatment option for patients with prostate cancer….
MARKET NEWS & TRENDS
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…..