PROTEIN CRYSTALS - Reshaping Traditional Biotherapeutic Formulations
Don Paul Kovarcik, MBA, and William Wittbold, MS, indicate that while protein therapeutics have enjoyed considerable commercial success throughout the past 3 decades, there still remain formulation and delivery challenges.
CARBON NANOTUBES - MGMR™ - A Medical-Grade Carbon Nanotube Designed for Medical Applications
Joseph S. Dillon, PhD, MBA, and Lainie Mulvanny discuss the transformation of CNTs into a unique composition of matter, marking a complete departure from the dirty, tangled micron bundles of CNTs that frustrated medical researchers for years.
DRUG DEVELOPMENT EXECUTIVE - Crown Bioscience: Enhancing the Drug Development Process
Jean Pierre Wery, President of Crown Bioscience, discusses the requirement for more accurate research models in oncology research, focusing on PDX models that have the ability to more adequately represent the conditions and mechanisms of immunotherapy in human patients.
EXTERNAL DELIVERY – The Big Hack Attack
John A. Bermingham says it is not a matter of IF your business is going to be hacked but WHEN your business is going to be hacked, but the vast majority of businesses in the US do not have any plans in place for such an event.
ANTIGEN-SCREENING SYSTEM - Perfecting the Promise of T Cell Therapies for Infectious Disease & Cancer
THE EVOLUTION OF IMMUNOTHERAPIES The human body is armed with an efficient and elegant immune system that fights pathogens and tumor cells using T cells…
PROTEIN PHOSPHORYLATION - New Pathways, New Tools: Phosphohistidine Signaling in Mammalian Cells
Xiaoyi Xu, MS, Chandreyee Das, PhD, and Michael Sturges, PhD, indicate that the phosphorylation of histidine has not been widely studied in mammalian cells, despite its discovery in bovine liver mitochondria, and ask the question, could the phosphorylation of histidine emerge as a therapeutically important pathway in mammals?
MANAGEMENT INSIGHT - The Wisdom of Bees: What the Honeybee Can Teach You & Your Company About Making Better Decisions
Derek Hennecke says once we understand what happens in our brains as we weigh our options, we can extrapolate this knowledge and look with fresh eyes at how CDMOs, large pharma, and the industry make decisions.
COMBINATION CORNER - How to Approach OTS Devices for Your Combination Product
Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges
Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.
EXTERNAL DELIVERY - Lead Your Company, Don’t Over Manage It
For many years, I have witnessed a continuing discussion on the question of, “what’s the difference between leadership and management?” Or is there one? I…
LYOPHILIZATION - A Lyophilization Scale-Up Model: Lessons Learned & Best Practices
Enrico Corona, indicates full scalability between laboratory and production lyophilization units allows for the development or optimization of freeze-drying cycle parameters that yield significant cost savings.
EXECUTIVE INTERVIEW - Transdermal Specialties: A New Dimension in Transdermal Drug Delivery
Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
PULMONARY DELIVERY - Pulmonary Delivery of Insulin to Treat Diabetes - A Debacle
T.R. Shantha, MD, PhD, FACA, says the market for new anti-diabetic therapeutic agents and their painless delivery is enormous and is sure drug companies and research scientists are in a race to develop a safer method other than the pulmonary and oral routes to deliver insulin.
Comparative Human In Vivo Study of an Immediate-Release Tablet Over-Encapsulated by Gelatin & Hydroxypropyl Methyl Cellulose Capsules – Impact of Dissolution Rate on Bioequivalence
Introduction Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties…
NANOPARTICLE CHARACTERIZATION - One Size Does Not Fit All: Nanoparticle Size Analysis for Nanomedicine Applications
Andrew N. Cleland, PhD, Jean-Luc Fraikin, PhD, Peter Meinhold, PhD, and Franklin Monzon, PhD, describe a new diagnostic instrument able to rapidly and accurately report detailed nanoparticle size distributions for a wide variety of nanoparticle types and concentrations in a range of different solutions.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Using a Single Provider Reduces Costs & Risk
Contributor Cindy H. Dubin highlights several CDMOs that are evolving their models to become their clients’ single provider and to accommodate their more potent, challenging products.
IMMUNOTHERAPY RESEARCH - The Shift Toward Combination Therapies
Jean Pierre Wery, PhD, indicates immunotherapy in combination with traditional treatments has the potential for becoming a more effective alternative to the current standard of care. These types of combination therapies are currently under investigation and appear to have synergistic effects compared to the use of one therapy alone.
LIPID NANOPARTICLES - EnCore(TM): Facilitating Delivery of RNAi Therapeutics to Treat Cancer
Marc T. Abrams, PhD, and Bob D. Brown, PhD, explain how nanoparticle technology has the potential to enable tumor bioavailability even in the absence of a targeting ligand.
EXTERNAL DELIVERY – It’s Never Too Late
“You’re going to do what?” was my wife’s reaction to my announcement. “Come on, you know it is something I’ve always wanted to do,” was…
DRUG DEVELOPMENT - Don't Overlook Key Preclinical Research
Robert Wenslow, PhD, and Ann Newman, PhD, believe too often, drug discovery scientists, material scientists, and formulation specialists work in silos throughout the drug discovery process. Better integration of their efforts can reduce drug development schedules, risk, and overall costs that provide direct competitive business advantages.
