Formulation Development
MDI CHARACTERIZATION - Closing the Gap Between In Vitro Test Data & the In-Use Performance for Metered Dose Inhalers
David A. Lewis, PhD, presents experimental data that shows how certain modifications to the Pharmacopoeial test methods used for MDIs may result in data that is more indicative of real-life performance, providing insight that can be used to enhance drug delivery characteristics.
EXECUTIVE INTERVIEW - Pfizer CentreOne: The Value of the Embedded-CMO Model
Peter Stevenson, Vice President and General Manager of Pfizer CentreOne, discusses the value and significance of the embedded-CMO model in the biopharmaceutical industry.
EXCIPIENT UPDATE - Solvent-Less Film Coatings: New Ethylcellulose Grade Enables Rapid Dry Powder Coating
Nick Grasman and Paula Garcia Todd, MS, present ETHOCEL HP as an innovative new product that helps customers increase productivity while still maintaining the advantages of Dow manufactured ETHOCEL, such as tight viscosity, narrow ethoxyl distribution, and reduced fiber content.
CONTROLLED RELEASE - Leveraging Precision Particle Fabrication® Technology to Create Patient-Friendly Dosage Forms
Cory Berkland, PhD, and Nathan Dormer, PhD, review how controlled-release powders offer a flexible and efficient approach to addressing a multitude of patient populations, while also improving compliance.
GALECTIN-DIRECTED THERAPIES - Targeting Galectin-3 Protein in Drug Development
Peter G. Traber, MD, believes we are only at the beginning of understanding the full potential of gal-3 targeted therapy, and the future likely holds additional high affinity, specific, galectin inhibitors that are bioavailable by routes other than the two currently in development.
MARKET BRIEF - Preferences for Targeted Therapies & Patient-Centric Approaches Drive Transformations in Oncology Drug Delivery Market
Frost & Sullivan Analyst Piyush Bansal says although chemotherapy has been successfully used for inhibiting cell growth throughout the past few decades, the side effects of chemotherapy have forced researchers to look for some alternative drugs (and how to effectively deliver them) for all types of cancer.
EXECUTIVE INTERVIEW - PCT: Manufacturing the Future of Cell Therapies
Robert A. Preti, PhD, discusses his company’s critical distinction from most other manufacturing partners, steady growth, and the primary challenges facing the cell therapy industry.
NON-CANNABIS THERAPY - Cannabinoid Therapy Without Using Cannabis: Direct Effects™ Topical β-Caryophyllene
Ronald Aung-Din, MD, in view of many documented medical benefits of cannabinoids, but with widely persisting regulations, misinformation, and stigma associated with cannabis, searches for a non-cannabis-derived source of cannabinoid therapy, such as found in β-Caryophyllene.
ASSAY VALIDATION - Biomarker Assay Validations – A Time for Change?
John L. Allinson, FIBMS, believes despite the increased use of biomarkers, it appears that many researchers are still continuing to use the FDA guidance document for validation even though it only critically addresses the validation of assays to support PK evaluation, and also has a limited scope described within the document in terms of studies where it should be used.
EXECUTIVE INTERVIEW - Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
SPECIAL FEATURE - Formulation Development & Manufacturing - CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs to highlight their capabilities in the areas of speed, quality, technology, and handling of complex APIs.
ELECTRONIC TONGUE INSTRUMENTATION - Improving the Palatability of User-Friendly Dosage Forms Using an Electronic Tongue
Detlev Haack, PhD, and Martin Koeberle, PhD, believe one exciting alternative starting to gain traction in the industry is assessment via an electronic tongue to detect and analyze all the compounds responsible for taste within a sample.
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.
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.
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.
