Featured Articles
FREEZE-DRYING MICROSCOPY - Unravelling the Complexities of Freeze-Drying Pharmaceuticals With Advanced Microscopy Techniques
Paul Matejtschuk, PhD, Prof Yvonne Perrie, and Robert Gurney, PhD, say FDM is being used to analyze the most challenging formulations that require sophisticated stabilization methods. By altering and adapting the three main freeze-drying stages to specific formulations, researchers are providing the tools needed for the pharma industry to improve its drug development processes and maintain drug stability when scaling up to production.
REGENERATIVE MEDICINE - Delivering on the Promise of Regenerative Medicine in Type 1 Diabetes
Thomas Donner, MD, explains how advances in stem-cell engineering, immune-evasion technologies, and vascularization of implanted cells have the potential to generate novel therapeutics that could lead to reduced treatment burden for patients with T1D and infuse new energy into efforts at finding a cure.
EXECUTIVE INTERVIEW - PCI Pharma Services: Broadening Our Biologics Footprint, Together
Shawn Cain, SVP Development & Manufacturing at PCI Pharma Services, discusses the recent acquisition, the opportunities this presents to Biopharma companies, and the current trends in the sterile fill-finish industry.
MEDICAL DEVICE UX DESIGN - Bridging the Divide Between People & Products: How UX Design Can Improve Medical Device Product Development
Aditya Jagannathan explains how human factors and industrial design can bridge the divide between people and products to maximize the likelihood that new medical devices will be safe and effective for the intended uses, users, and use environments.
AUTOMATION SOLUTIONS - The Future of Lab Tech Will Combine Automation, Accuracy & Agility
Rich Ellson and John Fuller, PhD, say accelerating development comes down to designing and using flexible automation solutions along with smarter instruments and new consumable paradigms to help meet researchers’ needs.
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.
