Formulation Development
MICROFLUIDICS - Taking a Microfluidics Approach to Drug Delivery
Richard Gray, MA, and Pavel Abdulkin, PhD, look at how microfluidics is changing the drug development sector and explore an exciting new non-encapsulating microparticle-based approach that offers “tunable” release of the API.
PERSONALIZED IMMUNOTHERAPY - Off-the-Shelf Personalized Immunotherapy for Breast Cancer: The BriaCell Solution
William V. Williams, MD, Markus Lacher, PhD, and Charles L. Wiseman, MD, explain how there is a clear need for ways to stimulate effective cancer-specific immune responses while avoiding time-consuming and costly individualized manufacturing.
THERAPEUTIC FOCUS - Antisense Drug Shown to Significantly Reduce Triglyceride Levels in Patients With Severe Hypertriglyceridemia
Ioanna Gouni-Berthold, MD, provides results from a clinical study indicating antisense technology can result in significant reductions in triglyceride levels in patients with hypertriglyceridemia.
MULTIPARTICULATE SYSTEM - Advances in Lipid Multiparticulate Technologies for Controlled Release
Jaspreet Arora, PhD, Samantha Saville, and Brett Waybrant, PhD, focus on a controlled-release LMP formulation to identify optimum annealing conditions and to better understand the annealing mechanism.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Drug & Packaging Ensure Safety, Compatibility & Stability
Contributor Cindy H. Dubin highlights some of the key players in the market and where they are focusing their efforts to ensure products are of the highest quality, safe, and easy to use.
EXECUTIVE INTERVIEW - Singota Solutions: Keeping Up With Trends & Technology as a CDMO
Brent Lieffers, Senior Director of Operations, discusses the need for keeping up with trends and technology as an innovative CDMO.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 3, Notable Transactions & Technologies of 2017
In part 3 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews transactions and technologies that provide greater insight into what we can expect in terms of product development and approvals over the next decade.
SOLID FORM SCREENING - Phase Appropriate Strategies for Solid Form Discovery & Development
Pingyun Chen, PhD, describes a rational, fit-for-purpose strategy for solid form screening and selection to ensure a successful yet cost-effective progression of drug candidates from discovery, clinical trials, and commercialization.
INTEGRATED DELIVERY SYSTEMS - The Value of an Integrated System for Combination Products
Theresa Bankston, PhD, says the fact that many of these therapies are designed for home delivery by patients or caregivers via subcutaneous injection, combined with increasing complexity of longer-acting formulations, larger injection volumes, and longer injection durations, has raised the bar for seamless injection delivery technology.
CONTAINER CLOSURE SYSTEM - Recent Prefillable Syringe Developments Mirroring Increasing Biotech Drug Product Demands
Stefan Verheyden says the container closure system has become a decisive factor for sustained market success, with autoinjectors and injection pumps as growing areas of interest.
INJECTABLE NANOMEDICINES - New Developments in Long-Acting Injectable Nanoformulations
Dongwei Guo, PhD, and Jingjun Huang, PhD, focus on the overview of nanoproducts in the market and the technologies to make long-acting injectable nanoformulations.
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.
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.
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.
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.
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.
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.
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.
