Search Results for: Life Cycle Management Strategies More
SPECIAL FEATURE – Formulation Development & Manufacturing – CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs April 4, 2017
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.
Joel Finkle emphasizes that as companies start to shift their thinking toward their commercial needs, they’re coming to realize that the regulatory function plays a crucial role in securing and maintaining market access and that Reg IM is more than simply a useful submission tool – that it is essential to managing the big picture.
SPECIAL FEATURE – Outsourcing Analytical Testing: The Gateway to Drug Manufacturing January 10, 2019
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
TRANSLATIONAL PHARMACEUTICS – Accelerating Early-Stage Drug Development With Integrated CDMO & CRO Services January 9, 2019
Peter Scholes, PhD, describes the current challenges and questions faced by drug developers in accelerating molecules to POC and developing optimized and scalable drug products for patient trials.
CONTROLLED RELEASE – Informed Selection of Modified-Release Technologies Provides Simpler Oral Dose Regimens August 27, 2018
Ronak Savla, PhD, reviews some of the physicochemical and biopharmaceutical characteristics of drugs and how they influence creation of a controlled drug delivery formulation.
MULTIPARTICULATE SYSTEM – Advances in Lipid Multiparticulate Technologies for Controlled Release June 4, 2018
Jaspreet Arora, PhD, Samantha Saville, and Brett Waybrant, PhD, focus on a controlled-release LMP formulation to identify optimum annealing conditions and to better understand the annealing mechanism.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Drug & Packaging Ensure Safety, Compatibility & Stability May 31, 2018
Contributor Cindy H. Dubin highlights some of the key players in the market and where they are focusing their efforts to ensure products are of the highest quality, safe, and easy to use.
DRUG DEVELOPMENT – To De-Risk Patient Acceptance of Biologic Drugs, Focus Early on Delivery September 11, 2017
Jeannie Joughin, PhD, asks what does a pharmaceutical company do when everyone wants more effective new therapies but no one – including third-party payers – wants to pay the price for their development? De-risk the drug development process, in every possible way.
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.
EXECUTIVE INTERVIEW – Vetter: Establishing a Successful Clinical Fill & Finish Manufacturing Site for Biologics April 3, 2017
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.
SPECIAL FEATURE – Bioavailability & Solubility: New Approaches to Enhance Drug Performance February 27, 2017
Contributor Cindy H. Dubin highlights many of the latest techniques to enhance bioavailability and solubility, how to determine the right technique for your compound, and how some companies are realizing faster time to market as a result.
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
NDA Group & PharmApprove Announce Merger March 28, 2016NDA Group and PharmApprove recently announced their merger. The newly combined company will allow clients to streamline the global development...
SPECIAL FEATURE – Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future May 5, 2015
Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.
SPECIAL FEATURE – Outsourcing Formulation & Manufacturing Development: Using Data & Unique Approaches to Solve Solubility Issues, Target Profiles & Customize Products March 31, 2015
Contributor Cindy H. Dubin finds that CMOs are embracing development projects in an effort to establish longer-lasting partnerships with their pharma and biotech clients. These contract developers are deploying innovative techniques aimed at improving solubility and fast-tracking products to market.