CLINICAL DEVELOPMENT STRATEGIES – Optimizing a Full-Package Strategic Alliance for Clinical Development Services
INTRODUCTION Pharmaceutical and biopharmaceutical companies are confronting a fundamental productivity challenge. In the past two decades, R&D cost has increased significantly, yet the rate of…
Peter Shaw and Yury Rozenman believe the pharmaceutical industry has reached a crucial inflection point, requiring access to new working methods and tools. But where should the pharmaceutical industry look for answers to these real-world challenges?
CONTAINER CLOSURE SYSTEMS – Application & Effectiveness of Daikyo Crystal Zenith® Container Closure Systems for Radiopharmaceuticals
Lloyd Waxman, PhD, and Vinod Vilivalam, PhD, believe a more promising application has been to label mAbs with a positron emitter for use in understanding the in vivo behavior and efficacy of targeted drugs in individual patients and for more effective drug development.
Physicists know it. Coffee drinkers live it. Roller coasters capitalize on it. Yet stock market investors - even coffee-drinking physicist-investors strapped into roller coasters -…
EXECUTIVE INTERVIEW – Norwich Pharma Services: Synchronized Outsourced Solutions for Contract Development & Manufacturing
Drug Development Executive: Kristin Arnold, PhD, Norwich’s VP of Product Development and Technical Services, talks about the company’s long history in pharmaceutical manufacturing, its evolution as a CDMO, the “perfect” client, and its role as a service provider from start to finish.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise
Contributor Cindy H. Dubin asked leading CMOs and CDMOs to describe the value-added services they offer with respect to formulation and manufacturing. Solving challenges of insufficient solubility, poor stability, identifying excipient candidates, and particle design topped their list of offerings.
DISPOSABLE TECHNOLOGY – Use of Disposable Technology in Clinical Fill & Finish Manufacturing: Benefits & Considerations
Claudia Roth, PhD, reviews not only the benefits of using disposables, but the real-world variables to consider when converting to single-use technology. The pathway begins with the question, why use disposables?
Sam de Costa, PhD, believes the launch of two stabilization and drug delivery platforms that have the potential to revolutionize the delivery of vaccines, therapeutics, and diagnostics, while significantly cutting costs, has attracted sharp interest from pharmaceutical and biotech companies around the world.
EXECUTIVE INTERVIEW – Hermes Pharma: User-Friendly Dosage Forms, a Win-Win Situation for Patients & Pharma
Drug Development Executive: Dr. Thomas Hein, Director, Sales & Business Development at Hermes Pharma, discusses how user-friendly dosage forms help put patients first, their advantages for patients and pharmaceutical companies, as well as the challenges associated with their development and production.
Contributor Cindy H. Dubin talks with some of the leading experts in the industry about the importance of outsourcing analytical testing in the biologic/biosimilar space, the associated challenges, and how to ensure products get to market safely and quickly.
EXCLUSIVE ONLINE CONTENT
SGS Joins Biophytis to Launch International Clinical Trial of COVID-19-Related Respiratory Failure Treatment
SGS has recently received approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) and has initiated the first site to begin a new clinical trial of….
Rentschler Biopharma & Vetter Team Up With Joint Goal to Simplify Processes & Optimize Time-To-Market
Rentschler Biopharma and Vetter recently announced their strategic collaboration to enhance their services and offer complementary….
Ajinomoto Bio-Pharma Services recently announce the launch of AJILITY, a flexible and agile drug product manufacturing platform, designed to advance….
Moderna & Catalent Announce Collaboration for Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
Moderna, Inc. and Catalent, Inc. recently announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate…..
AGTC Announces Significant Productivity & Quality Enhancement to Its Proprietary Manufacturing Process
Applied Genetic Technologies Corporation recently provided an update on the continued productivity and quality improvements made in its proprietary manufacturing platform that is….