THROAT SPRAY SYSTEMS - Key Considerations When Developing a Throat Spray Solution
Degenhard Marx, PhD, and Günter Nadler discuss the treatment of sore throats via a pump spray and explore the considerations to be made when developing a reliable spray product.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 2, Notable Product Approvals of 2017
In part 2 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews the more interesting individual products approved throughout the past year.
ORALLY INHALED PRODUCTS - Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
PREFILLED SYRINGES - Prefilled Syringe Automated Inspection & End-Product Testing
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
MONOCLONAL ANTIBODIES - The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities From Clone to Clinic
Howard L. Levine, PhD, and Brendan R. Cooney, provide a guide to product development companies, service providers, investors, and analyst as they work their way through the complex and rapidly evolving world of therapeutic monoclonal antibodies.
SPECIAL FEATURE - Challenging Molecules Drive Developers to Get More Creative With Excipients
Contributor Cindy H. Dubin highlights the techniques various excipient manufacturers are using to develop more innovative and effective ingredients to improve the performance of drug molecules.
EPR SPECTROSCOPY - Bringing EPR to a Wider World: Biological ROS & RNS Detection
Kalina Ranguelova, PhD, demonstrates how the latest digital and microwave technologies in benchtop EPR instrumentation is giving researchers new insight into ROS and free radicals that may shape the future development of more effective treatments of disease.
EXECUTIVE INTERVIEW - MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
FDA UPDATE - The FDA's New Drug Approval Process: Development & Premarket Applications
Kaiser J. Aziz, PhD, in this latest FDA update, emphasizes quality system approaches to the development and availability of new drug information presented in the proposed labeling of the product.
CLINICAL TRIALS - Inconsistencies Prevalent in Study Start-Up
Craig Morgan believes as stakeholders are increasingly aware that better study start-up (encompassing the activities associated with site identification, feasibility assessment, selection, and activation) processes are linked to shorter clinical timelines, the emphasis has been shifting in that direction.
3D PRINTING - 3D Printed Drugs Hold Great Potential for Personalized Medicine
Contributor Cindy H. Dubin explores 3D printed drugs in the wake of a milestone in the pharma industry when Aprecia Pharmaceuticals’ Spritam (levetiracetam) tablets became the first FDA-approved prescription drug product manufactured using 3D printing technology.
DNA THERAPEUTICS - DNAbilize-ING Antisense
Peter Nielsen, MBA, explains how his company’s candidates are differentiated from those in development at other companies by the type of modification to the antisense molecule and the method by which it is conveyed to its target cell.
EXECUTIVE INTERVIEW - NanOlogy: Submicron Particle Platform Transforms Systemic Chemotherapy Into Local Delivery
Marc Iacobucci, Managing Director of NanOlogy, discusses his company’s technology, clinical program, and efforts to transform cancer therapy.
GAS-POWERED DELIVERY - Innovating Injectable Devices to Deliver Today’s Pharmaceuticals
Steven Kaufman believes that with autoinjectors in high demand by the biopharma industry, gas-powered delivery systems may have the solution to many of the difficulties the industry is facing.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, focuses on the macro aspects of the 2017 product approvals.
INTRADERMAL DELIVERY - New Technology Brings Simplicity & Scalability to Intradermal Drug Delivery
Boris Stoeber, PhD, Sahan Ranamukha, PhD, and Rory St. Clair describe the Microdermics technology and its improvements over the conventional subcutaneous route of administration.
SCALE-UP & MANUFACTURING - Smart Formulation, Processing & Engineering Solutions to Solve Drug Product Scale-Up & Manufacturing Challenges With Minimum to No Regulatory Impact
Anil Kane, PhD, MBA, explains how many smart formulation process or engineering solutions can be applied to overcome challenges of the material properties to successfully manufacture quality products at the development and commercial scale with minimum to no clinical or regulatory impact.
SPECIAL FEATURE - Improving Bioavailability & Solubility: A Top-Down Versus Bottom-Up Approach
Contributor Cindy H. Dubin speaks with several innovative companies on their science, techniques, and technologies aimed at improving bioavailability and solubility.
SPECIAL FEATURE - Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
NANOMEDICINES - V-Smart® Nanomedicines: Non-Invasive Targeted Brain Therapeutics for CNS Diseases
Susan Rosenbaum, JD, and Irwin Hollander, PhD, present a unique and novel solution to this greatest challenge in medicine for brain disease treatment, considered the “Holy Grail of Neuroscience,” with their breakthrough innovation.
