Featured Articles
CELL & GENE THERAPY - State of the Industry – Where is C> Headed?
Bill Vincent believes if the industry wants to keep moving up the steep growth curve, then capacity and raw materials must be readily available. The innovations in therapies, platforms, and processes will all come with time, money, and increasing availability of resources.
SPECIAL FEATURE - Excipients: Exciting Expansion & Innovation
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.
GLOBAL REPORT - 2021 Global Drug Delivery & Formulation Report: Part 1, A Review of 2021 Product Approvals
In part 1 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2021 product approvals.
FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
SUPPLY CHAIN MANAGEMENT- Are Supply Chains Up for the Post-Pandemic Challenge?
John Swift believes each medical device manufacturer will discover different patterns of risk as a result of COVID-19. It is therefore imperative that businesses carry out an in-depth and urgent re-appraisal of their supply chain, as failing to do so may cause commercial damage.
EXECUTIVE INTERVIEW - Syner-G BioPharma: A Track Record of CMC Excellence
Prabu Nambiar, PhD, Founder and CEO Syner-G, discusses the company’s evolution, its approach to CMC, and the future of the organization.
PLATFORM TECHNOLOGY - Predictive Medicine, Biomarkers & the Multiple Unmet Needs in Acute Respiratory Distress Syndrome
Joe G.N. Garcia, MD, and Stan Miele believe the unmet need in ARDS is to identify reliable, validated ARDS biomarkers that minimize ARDS heterogeneity and allow for stratification of subject selection for enrollment in clinical trials of tailored therapies. Combined with a more streamlined drug-approval process, biomarker- and genotype-based treatment of specific ARDS endotypes has never been as within reach as it is today.
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.
