Featured Articles
BATCH RELEASE - The Business Case for Reinventing Batch Release
Aparna Seksaria reviews how for pharmaceutical companies — and pharma supply chains — to bring safe, commercial-ready products to market quickly and profitably, and for them to meet growing demand for highly personalized, batch-size-one types of products, it’s critical that they take steps to de-risk and speed up processes like batch release, and do so without compromising quality, safety or the bottom line.
EXECUTIVE INTERVIEW - inVibe: Changing the Research Game With Voice
Fabio Gratton, CEO of inVibe, discusses patient-focused drug development (PFDD), his company’s language model, and the value this technology brings to a patient’s treatment journey.
PERMEABILITY STUDIES - Onion Epithelial Membrane as a Model for Predicting Intestinal Absorption of Drugs
Antoine Al-Achi, PhD, Mounika Nangineedi, MS, Chaitali Koli, MS, et al, study 19 drugs with varying partition coefficient, water solubility, and molecular weight values to compare their diffusion through the middle epithelial membrane of onion with that of their Caco-2 cell line.
SPECIAL FEATURE - Solubility & Bioavailability: Utilizing Enabling Technologies
Contributor Cindy H. Dubin interviews several leading companies on how they are using innovative technologies, such as lipid nanoparticles to achieve a high drug loading, combining anti-solvent continuous crystallization with micro-mixing technology to control crystallization and reduce crystal size, and how a robotic capsule can improve bioavailability in the range of 47% to 78%.
DRUG DEVELOPMENT - The Promise of Cutting-Edge Microbiome-Based Therapeutics
Andrew Thomson, Brian Carpenter, and Robert Broadnax focus on how developers must strategically address and overcome specific challenges to successfully drive development and eventual adoption of microbiome-based therapies.
NASAL DELIVERY - Improving Nasal Drug Delivery With Permeation Enhancing Technology
Stuart Madden, PhD, focuses on the use of alkylsaccharides as absorption enhancers for nasal delivery of a wide range of drug types.
FORMULATION DEVELOPMENT - Impact of Excipients & Manufacturing Process on Solubility-Enhanced Ritonavir Tablet Size & Weight Reduction
Gayatri Khanvilkar, MPharm, Ajit Bhagat, and Tejas Gunjikar, PhD, investigate bulking agents and disintegrants to develop efficacious Rotonavir tablets with improved in vitro release.
DATA STRATEGIES - As We Shift Toward Biologics, We Also Need to Shift Toward Smarter Data Management
Christian Marcazzo explains how adopting a new kind of data strategy might be disruptive to the expectation of how biologics development is carried out — but it may also be transformational.
MARKET LANDSCAPE - The Future of Cancer Care Post-Pandemic: What Doctors, Patients, and the Healthcare Industry at Large Should Expect
Angelos Stergiou, PhD, explains how the COVID-19 pandemic saw failures in the healthcare delivery system not only in general medicine, but also specifically in oncology. At the same time, several opportunities came to light during such a difficult, frightening moment, bringing a number of large- and small-scale innovations forth.
EXECUTIVE INTERVIEW - Kytosan USA, Inc.: Blazing a Trail in Chitosan Manufacturing in the United States
Dr. Joseph F. Bristow, Chief Technology Officer for Kytosan USA, discusses chitosan and its impact on the pharmaceutical industry, as well as Kytosan USA’s production plans.
GENE EDITING TECHNOLOGY - Harnessing a Cell’s Natural DNA Repair Process to Develop Medicines With Higher Levels of Precision & Durability
Mariana Nacht, PhD, reviews a new gene editing approach that harnesses a cell’s natural DNA repair process, known as homologous recombination, to insert a corrective copy of the gene (or transgene) at a precise spot in a patient’s genome.
INJECTION TECHNOLOGY - Patient Centricity in Insulin Injection: Using Technology to Improve Self-Administration
David T. Novotny discusses how advances in smart technology have opened up new options for people with diabetes and explores how injection technology has made self-administration of insulin easier, and how it will continue to develop into the future.
CDMO INNOVATION - How a Global CDMO Puts Innovation at the Forefront of its Business Strategy
Kai Vogt, Senior Vice President Corporate Development/Legal/Corporate Compliance/IT, Vetter, explains how a global CDMO puts innovation at the forefront of its business strategy.
SPECIAL FEATURE - Analytical Testing Trends in 2022
Contributor Cindy H. Dubin reports on the innovative technologies and techniques that several leading outsourcing providers currently offer for both small and large molecules.
FORMULATION FORUM - Formulation & Process of Lipid Nanoparticles for Delivery of Small Molecules & Biologicals
Jim Huang, PhD, explains how recently, lipid nanoparticles have emerged as a drug delivery system for biologicals, especially for the COVID-19 mRNA vaccines in which LNPs play a vital role in transporting mRNA into the target cells.
ORGAN-ON-A-CHIP - A Novel Way to Accurately Test Delivery of Non-Standard Formulations
David Hughes, PhD, says ultimately, the goal of OOC technology is to improve the translatability of data between the lab and the clinic. Through a lung-on-a-chip approach, it is possible to recreate the histoarchitecture, phenotype, and function of bronchial and alveolar areas of the lung.
EXOSOMES - The Next Evolution in Therapy Delivery Beyond the Cell Membrane: The Promise of Exosomes
Linda Marbán, PhD, says perhaps the best way to get past the cell membrane is to deliver contents the same way that cells send information to each other. And that is by the exosome, which in the case of targeted therapy delivery, has been identified as an alternative that shows powerful promise.
COATING TECHNOLOGY- Combining a State-of-the-Art Bromobutyl Formulation With a Proven ETFE Film for Exceptional Chemical Performance
Julie Suman, PhD, Sebastien Cordier, and Estelle Verger discuss the properties of the ETFE film coating technology used for PremiumCoat(R) vial stoppers and pre-filled syringe plungers. When combined with pure Bromobutyl formulation, the film forms a barrier that can reduce the number of leachables transferred into the solution, and their quantity by up to 98%.
EXECUTIVE INTERVIEW - EyePoint Pharmaceuticals, Inc.: Disrupting Treatment Paradigms
Nancy Lurker, President and CEO of EyePoint Pharmaceuticals, discusses how she is not only working to disrupt treatment paradigms in ophthalmic drug delivery, but also disrupting leadership paradigms as a female CEO of a company with 2020 total revenues of $34.4 million.
CYBERSECURITY - Cybersecurity for Connected Medical Devices: A Holistic Approach During the Entire Product Lifecycle
Nicola Alagia explains why cybersecurity is important for connected medical devices and how to integrate ad hoc activities to tackle cybersecurity in the early phases of product development.
