Formulation Development
CELLULAR MICROENCAPSULATION - Cell Encapsulation for Drug Delivery & Disease Treatment
Gerald W. Crabtree, PhD, indicates drug or treatment delivery that employs microencapsulation, one of many promising developments in the field of regenerative medicine, offers not only treatments but also potential cures for a wide variety of maladies.
ANTIMICROBIAL RESISTANCE - MGB: The Minor Groove Binder
Dawn A. Firmin, MSc, PhD, explains how MGB has dedicated its focus to the development of a new class of small molecules, with specific antibacterial activity against susceptible and resistant bacteria.
EXECUTIVE INTERVIEW - Vetter: Establishing a Successful Clinical Fill & Finish Manufacturing Site for Biologics
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing the services of a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
ANTIMICROBIAL LIPIDS - Attenuating the Use of Medically Important Antimicrobial Drugs in Food-Producing Animals: What Role Can cGMP Lipids Play?
Ryan Littich, PhD, highlights some of the most significant, pathogen-borne diseases relevant to food-producing animals and reviews the antimicrobial properties intrinsic to midchain triglyceride lipolysis products.
SAMPLE PREPARATION MARKETS - Automation & Application Trends Drive Growth in Sample Preparation Markets
Christi Bird indicates sample preparation remains a critical task in many research and testing workflows across biopharmaceutical, basic research, clinical, and industrial applications. While the market lacks the hype and excitement of NGS, CRISPR/Cas9, or the microRNA and epigenetics boom several years ago, the sample preparation market will always be a slow and steady gainer on an already large market size.
COMBINATION CORNER - Keys to Avoiding Common Pitfalls in the Development of Product Requirements for Drug Combination Products
Jerzy Wojcik says it is more important than ever to bring the right team together early in a project to capture product requirements correctly. The cost of missing needs or requirements goes up exponentially as development proceeds, and many of these requirements can be identified early in the project if the right individuals are at the table.
AAV VECTOR MANUFACTURING - Challenges & Opportunities in the Manufacturing of AAV Vectors Used in the Delivery of Gene Therapy Treatments
Daniel C. Smith, PhD, indicates there remains a clear need for improved process productivities, and the need to develop manufacturing processes that can be applied to a wide number of AAV-based viral vector therapeutic candidates.
BIOMARKERS - FDA’s Design Control Requirements for Biomarkers in Drug Development
Kaiser J. Aziz, PhD, says the availability of validated biomarker-drug companion products will enable the molecular diagnostics and pharmaceutical industries to develop and rely on new genomic biomarkers in order to elucidate disease pathways, stratify patient populations, and monitor safe and effective use of these products.
CELL THERAPY - PLX-R18: Cell Therapy for Treatment of Acute Radiation Syndrome & Bone Marrow Failure Diseases
Racheli Ofir, PhD, and Noa Sher, PhD, report on studies showing that PLX-R18 is a strong candidate for the treatment of H-ARS as well as a plethora of bone marrow failures with similar symptomatology.
THERAPEUTIC FOCUS - GSNOR Inhibition to Stabilize & Improve Mutant CFTR Processing
Steven Shoemaker, MD, reviews how cavosonstat represents a safe and effective option for patients with CF with at least one copy of the F508del-CFTR mutation; and that when used with correctors and potentiators, improves patient outcomes including lung function.
SPECIAL FEATURE - Bioavailability & Solubility: New Approaches to Enhance Drug Performance
Contributor Cindy H. Dubin highlights many of the latest techniques to enhance bioavailability and solubility, how to determine the right technique for your compound, and how some companies are realizing faster time to market as a result.
SPECIAL FEATURE - Analytical Testing: Market Drivers, Growing Demand & Client Needs
Contributor Cindy H. Dubin spoke with several testing providers to find out what services they offer, trends they identify, and how they have specifically addressed clients’ needs throughout the past year.
ORALLY DISINTEGRATING TABLETS - Patient-Centric Dose Design, Developments in Orally Disintegrating Tablets
Leon Grother, MS, and Mathias Bayru, MS, MBA, indicate recent developments in ODT technology have widened the range of actives that can be formulated and product types that are possible. In particular, the promise of formulating biologics and ODT vaccines is hugely exciting.
FORMULATION DEVELOPMENT - Optimizing the Spray-Drying Parameters for a Formulation of Nanoparticles-In-Microparticles System of Acetazolamide
Parijat Pandey, MPharm, and Harish Dureja, PhD, examine the consequence of spray-drying parameters that are inlet temperature and feed rpm on entrapment efficiency, loading capacity, percentage yield, and particle size.
BIODEGRADABLE FIBERS - Enabling Controlled Pharmaceutical & Biologic Delivery for Next-Generation Medical Applications
Kevin Nelson, PhD, discusses how wet-extruded fiber eliminates the traditional limitations of pharmaceuticals and biologics that may be incorporated into implantable medical devices with melt extrusion or electrospun fibers, microspheres, or nanoparticles.
CNS DELIVERY - Bypassing the BBB: Drug Delivery From the Olfactory Mucosa to the CNS
T.R. Shantha, MD, PhD, FACA, explores and explains how therapeutic and non- therapeutic agents can reach the brain, bypassing through the formidable BBB based on the unique microanatomic and physiologic characteristics of the nasal olfactory mucosal route and its CNS connections that allow transportation directly into the CNS.
EXECUTIVE INTERVIEW - Viral Gene: Protein-Targeting Cancer Vaccine Could Boost Survival Rates
Harry A. Arena, MBA, President & CEO of TDT, Chris Kim, President & General Counsel, Viral Gene, Inc., and Dr. Scott Waldman, Professor & Chair of Sidney Kimmel Medical College’s Department of Pharmacology & Experimental Therapeutics at Thomas Jefferson University, discuss the unique characteristics of the vaccine, the patients who will benefit the most, and how a research team captured the attention of investors.
COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
EXECUTIVE INTERVIEW - Avista Pharma Solutions: Experience, Responsiveness & Expanded Capacity Driving Growth
Patrick Walsh, CEO of Avista Pharma Solutions, talks about his company’s range of capabilities and what is driving growth in this dynamic industry.
PROTEIN THERAPEUTICS MARKET - Technology Advances Spur Market Growth of Protein Therapies
Laurie L. Sullivan and Shalini S. Dewan, BCC Research Analysts, believe with the advent of genetic engineering and recombinant DNA technology, it is now possible to produce a wide variety of human proteins, and that these novel technologies have lifted the market for therapeutic proteins to new heights.
