Featured Articles
FORMULATION FORUM – Nanosuspensions - An Enabling Formulation for Improving Solubility & Bioavailability of Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, focus on the role of excipients and methods for preparation and application of nanosuspensions in injectable, ocular, topical, and oral drug delivery.
EXECUTIVE INTERVIEW - Lonza Small Molecules: Facing Up to the Challenges of Drug Development
Jan Vertommen, Lonza’s Head of Commercial Development (Small Molecules) discusses some of the challenges facing the sector and how his company is looking to address them.
PHARMACEUTICAL GLOBALIZATION - Navigating Opportunities & Obstacles
Jürgen Hönig says rapid globalization of the pharmaceutical industry has created new complexities as companies navigate different regulations and government policies, but there are many reasons for optimism, including harmonization, collaboration, and convergence.
CLOUD COMPUTING - Revolutionizing Antibody Discovery: The Role of Cloud Computing
Suhani Nagpal, PhD, Laura Spector, PhD, and Frank Erasmus, PhD, discuss the role of cloud computing in antibody discovery, its benefits, and its potential applications in the field of biotechnology.
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.
FUNCTIONAL EXCIPIENTS - Much More Than Filler: Solving the Challenge of Patient Non-Compliance
Carin Siow, PhD, explains how the progress to tackle the root causes of medication mis-use has been frustratingly slow and believes the pharma industry’s secret weapon in the fight against non-compliance are functional excipients.
EXECUTIVE INTERVIEW - HERMES PHARMA: Reducing Risk, Speeding Development - A CDMO Model Including GCP-Sponsorship to Better Meet the Needs of Pharma Companies
Dr. Martin Koeberle, Head of Analytical Development & Stability Testing, and Dr. Bernice Wild, Head of Stability Testing and Senior QA Manager GCP, at HERMES PHARMA, discuss the challenges of developing innovative oral medicines, as well as how these new service offerings are helping meet a critical need among companies looking to bring portfolio-enhancing formulations to market.
PRIMARY CONTAINER CLOSURE SYSTEMS - In From the Cold: Realizing the Benefits of Primary Packaging Innovation for Lyophilized Drug Products
Neal Higgins discusses the benefits and challenges associated with lyophilization before reviewing some of the current macro influences, West’s design philosophy and QBD blueprint, and data to demonstrate the efficacy of the 4040 elastomer platform.
PLACENTA-ON-A-CHIP - The Future of Drug Discovery In Women’s Health
Hagar Labouta, PhD, presents how researchers continue to increase the complexity of their placenta-on-a-chip models and, as their research progresses, they are confident this technology will aid the development of novel therapies to treat a wide range of maternal and fetal conditions.
CLINICAL TRIALS - 2023 & Beyond: How Technology is Changing the Face of Clinical Trials
Betsy Wagner and Marie E. Lamont explain how before anyone can take full advantage of this opportunity, education about the technology and the practical benefits, viewed through the lens of understanding historical lessons learned, will be the critical next step.
NATURAL LANGUAGE PROCESSING - Mandatory IDMP Compliance is Almost Here - How NLP Can Help
Simon Johns says with the US scheduled to implement IDMP this year and the EU in the process of implementation, IDMP is no longer just a distant requirement. It is happening now, and all organizations should be prepared for mandatory use this year.
