Formulation Development
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.
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.
NASAL DELIVERY - A Promising Route of Drug Delivery to the Brain: Scientific Considerations
Vinayak Pathak, MPharm, MBA, indicates after reviewing clinical experiments published in this area, it is evident that formulation design, altering the physico-chemical properties of the drug, addition of absorption enhancers, and mucoadhesive polymers did result in higher bioavailability of drugs in animal models via the nasal route when compared to parenteral administration of the same drug.
SPECIAL FEATURE - Analytical Testing - Contractors Take on the Challenge of Complex Molecules
Contributor Cindy H. Dubin highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.
PARTICLE DESIGN TECHNOLOGY - Technical Guide for Solid Dispersion Development
Nathan Barksdale and Elizabeth Hickman, MBA, say there are many articles on the theory and scientific principles underpinning the benefits of ASD, and introduce the reader to the steps involved in the development and manufacturing of an ASD via the spray drying process.
FOAMED SILICONE - Molded Porous Silicone for Delivery of Macromolecules & Low-Solubility APIs
James Arps, PhD, and Matt Petersen, PhD, investigate how foamed silicone is capable of sustained, controlled elution of hydrophobic small molecule and large macromolecular payloads.
INTRABODY DELIVERY - The Feldan Shuttle Technology: A Peptide-Based Method to Deliver Antibodies
Thomas Del’Guidice, PhD, Nancy Messier, PhD, and David Guay, PhD, present the Feldan Shuttle technology, a peptide-based delivery method that could provide efficient and safe intrabody delivery in mammalian cells.
GENE-EDITING TECHNOLOGY - How CRISPR-Cas9 Technology Will Play a Vital Role in the Future of Human Therapeutics & Drug Discovery
Kevin Holden, PhD, explores how this technology can be utilized in research efforts toward the development of new therapies and how it will play a vital role in the future of biopharma and drug discovery.
ANTIBODY THERAPEUTICS - Teneobio’s Next Generation of Multispecific Antibody Therapeutics
Omid Vafa, PhD, MBA, reviews unique technologies, including a transgenic rat platform expressing human heavy chain antibodies, and a state-of-the-art sequence-based discovery engine, to create novel multispecific antibodies for various therapeutic indications.
PACKAGING - Child-Resistant Features for Container Closure Systems
Stefan Hellbardt, PhD, Guenter Nadler, and Degenhard Marx, PhD, highlight the successful introduction of Aptar’s first CR/SF nasal spray pump and the first dermal dispenser on the US market.
NEXT-GENERATION SEQUENCING - Emerging Clinical Applications & Projections to 2022
Laurie L. Sullivan and John Bergin, MS, MBA, say the growth curve for clinical applications of NGS is approaching an upward trajectory as existing applications gain traction and new ones begin to establish a foothold.
CANCER IMMUNOTHERAPY - Building on Initial Successes to Improve Clinical Outcomes
Allan B. Haberman, PhD, provides an updated discussion of approved and clinical-stage agents in immuno-oncology, including recently approved agents. He also addresses how researchers and companies are attempting to build on prior achievements in immuno-oncology to improve outcomes for more patients.
EXECUTIVE INTERVIEW - Lonza Pharma & Biotech: Taking on the Next Challenges in Small Molecules
Gordon Bates, Head of Chemical Division at Lonza Pharma & Biotech, shares his perspective about industry needs and how strategic acquisitions are enhancing Lonza’s position as a development and manufacturing partner of choice.
TABLET FORMULATION - Reformulation of Tablets to Resolve Sticking & Picking Issues Faced on Compression: A Case Study
Smruti P. Chaudhari, PhD, and Anshul Gupte, PhD, successfully reformulated tablets using the potassium-salt form of Compound XY without adding any new excipient. Through the reformulation, they also resolved earlier issues faced during tablet compression.
GENE & CELL THERAPY - Its Growing Potential to Disrupt Drug Research & Healthcare Delivery
Jeff Galvin believes as the pace of gene and cell therapies accelerates over this next decade, potential cures for chronic diseases, cancer cures, and autosomal defect cures will result, and the efficacy of new therapeutics may move as much as $500 billion from traditional pharmaceuticals to gene technologies.
SPECIAL FEATURE - Platform Technologies - Derisking & Transforming Drug Development
Contributor Cindy H. Dubin, in this second annual report, speaks with several exciting and innovative companies whose platform technologies are transforming drug development.
LIPID-BASED DELIVERY - Are Lipid-Based Drug Delivery Systems in Your Formulation Toolbox?
Jason M. LePree, RPh, PhD, reviews the causes of poor bioavailability for drugs and provides an introduction to lipid-based drug delivery systems, and how the formulation approach can be used to overcome impediments to good bioavailability of therapeutic actives.
EXECUTIVE INTERVIEW - Particle Sciences: Experts in Development & Manufacturing of Complex Dosage Forms
Dr. Mark Mitchnick, CEO of Particle Sciences and CMO of Lubrizol, discusses the rise of complex drug products, the capabilities needed to develop and manufacture these products, and the company’s expansion in this area.
SPECIAL FEATURE - Injectable Drug Delivery: New Technologies Deliver Biologics & Differentiate Brands
Contributor Cindy H. Dubin reports on a segment of the drug delivery industry that will see its market revenue double in just 5 years in response to a growing need to deliver highly viscous, high-volume drugs.
