Search Results for: CONTRACT MANUFACTURING Flexibility in an
Mike Schaefers, PhD, and Mike Treadaway say more than ever, contract manufacturing must deliver continuous innovation and flexibility to accommodate the delivery of a wide range of drugs throughout each therapy’s lifecycle.
John W. Burke, MS, says that success in lyophilization transfer and scale-up projects depends on a structured approach to information sharing between a pharma company and its CDMO partner, and should include extensive details about the APIs or bulk drug substance characteristics and planned development and clinical programs.
- Evonik Completes Multi-Million Dollar Expansion of its CMO Capabilities for API & Advanced Intermediates
Evonik, a global CMO leader for API and advanced intermediates, recently announced the completion of a €36-million expansion of its contract manufacturing capabilities in the US and Europe.
- 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.
- 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.
- 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?
- 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.
Matthew Moorcroft, PhD, warns that in the fast-moving pharmaceutical industry, change is the only constant. And to keep up with market developments, small molecule manufacturers must first understand the trends.
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.
- 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.
Thomas Otto believes a specialized CDMO can provide efficient solutions to the many challenges surrounding lyophilized substances. But it should be ascertained they have packaging, manufacturing, and lyophilization expertise.
Robert C. Getts, PhD, and Jessica Bowers review how the 3DNA platform is composed entirely of noncoding DNA assembled through the sequential hybridization of single strands of DNA into a network of double-stranded nucleic acid having a controlled architecture, and multiple attachment sites for drug and targeting molecules.
Medhat Gorgy, President and CEO of PYRAMID Laboratories, Inc., discusses his success in building futures with his clients and more importantly, the lessons he’s learned along the way.
Steven Kaufman believes that with autoinjectors in high demand by the biopharma industry, gas-powered delivery systems may have the solution to many of the difficulties the industry is facing.
- 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.
Frost & Sullivan Analyst Ruplekha Choudhurie reviews some BA approaches that are being developed by a number of companies that can mitigate the biological, physical, and chemical barriers for effective delivery of poorly soluble and permeable drugs.