Featured Articles
DIGITALIZATION STRATEGIES - The Era of Technological Transformation in Pharma: Digitalization’s Role in Future-Proofing the Pharma & Biotech Industries
Kai Vogt says organizations that keep up with the technological transformation and incorporate employees in new digitalization strategies can likely achieve the greatest-possible success, which can be driven by the ability to produce high-quality drug products, and the commitment to reskilling employees, bringing human-centric value to an increasingly tech-driven industry.
REGULATORY AFFAIRS - Rethink the Regulatory Dynamic: A Better Approach for Being Your Product’s Best Advocate
Nick Smalley says as drug device combination products grow more complex, regulations increase commensurately. However, to implement and enforce appropriate regulatory standards and truly ensure product safety, regulators must understand what it is they are regulating.
EXECUTIVE INTERVIEW - Precision NanoSystems Inc. (part of Cytiva) & SCIEX: Lipid Impurities Within mRNA-LNPs
Kerstin Pohl, Senior Manager of Cell & Gene Therapy & Nucleic Acids at SCIEX, and Scott Ripley, General Manager of Nucleic Acid Therapeutics at Cytiva, dive into the detection of a new class of impurities within mRNA drugs and the impact it has on manufacturing.
LIPOSOMAL PEPTIDE THERAPEUTICS - Revolutionizing Oncology: Unleashing Innovative Strategies to Tackle Challenging, High-Value Drug Targets
Natalia Zisman, Krishna Allamneni, PhD, and Stacy W. Blain, PhD, explain how targeting downstream signaling proteins offers a promising approach to effectively mitigate the emergence of drug resistance that precision oncology therapies leave behind.
CARBOMER CHEMISTRY - Breaking Ground in Controlled Release
Nicholas DiFranco, MEM, believes by working alone or alongside other well-established excipients for controlled release such as HPMC, the power of carbomer chemistry can help drug developers to overcome common challenges associated with controlled-release formulations without resorting to more complex techniques.
DELIVERY TECHNOLOGY - Topical NeuroDirect™ Ketamine in the Treatment of Neuropathic Pain Syndromes: Fibromyalgia, Neuropathy, Radiculopathy & Causalgia/Complex Regional Pain Syndrome
Ronald Aung-Din, MD, and Chantelle Martin, MBChB, explain how targeting such chronic pain with a fast-acting, non-systemic, convenient, and easy-to-use at-home NeuroDirect ketamine cream could be of significant benefit in patients with CRPS as well as other neuropathic pain states, including chronic neck and back pain.
FORMULATION FORUM - CUBOSOMES – The Next Generation of Lipid Nanoparticles for Drug Delivery
Jim Huang, PhD, and Shaukat Ali, PhD, shed light on the design and formation of cubosomes with special focus on their applications for delivery of hydrophobic and hydrophilic small and large molecules, including oncology drugs and polynucleotides (DNA, mRNA, and siRNA).
PLATFORM TECHNOLOGY - The PTXΔLNP® Platform: On the Promise of Developing New LNPs for Tomorrow’s mRNA Therapies
Charlotte Dunne, PhD, Katrin Radloff, PhD, and Leonidas Gkionis, PhD, review the PTXΔLNP platform and how it offers a synergistic sister technology to the mRNA platform to obtain potent mRNA-LNPs for therapeutic applications.
SOLUBILIZING & STABILIZING TECHNOLOGY - CAPTISOL® - Part Perseverance & Part Serendipity
Vince Antle, PhD, James Pipkin, PhD, and Lian Rajewski, PhD, say with decades of experience, proven safety, and recent and forthcoming authorizations in several new routes of delivery, the Captisol Team is looking forward to the next 2 decades and more of new drug products, new applications, and continued improvement in the technology.
BIOLOGICS DEVELOPMENT - Five Steps to a Robust Cell Line Development Process
Robert Gustines reviews the critical steps for designing and implementing a robust cell line development process to help overcome the obstacles that often hinder biologic production.
EXCLUSIVE ONLINE CONTENT
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
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.
LIPOPHILIC SALTS - Opportunities & Applications in Oral Drug Delivery
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.