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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.
COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products January 13, 2017
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, 2016
NDA 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.
goBalto Announces Latest Release of goBalto Activate January 13, 2015
goBalto, Inc., the leading provider of cloud-based clinical study startup solutions, recently announced the release of its latest version of goBalto...ADVANCED DELIVERY DEVICES - Innovation Without Change: What is it & What Can it Mean for Pharmaceutical Manufacturers? January 7, 2015
John A. Merhige, MEM, and Dan Thayer believe a rigorous, risky development and regulatory process forces pharmaceutical manufacturers into a bad compromise between advances in delivery systems and the time, cost, and risk associated with those advances.
EXECUTIVE INTERVIEW - 4P Therapeutics: Developing New & Innovative Transdermal Products June 3, 2014
Drug Development Executive: Steven Damon, Founder of 4P Therapeutics, discusses his vision for the company and how 4P intends to create new and innovative transdermal products that meet the needs of patients, physicians, and payers.
CLOUD COMPUTING - Enabling Better Collaboration in the Cloud May 7, 2014
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?
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Early-Stage Partnerships Are On The Rise April 2, 2014
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.
EXECUTIVE INTERVIEW - Hermes Pharma: User-Friendly Dosage Forms, a Win-Win Situation for Patients & Pharma March 5, 2014
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.
LYOPHILIZATION PACKAGING - Packaging Freeze-Dried Substances - There Are Options January 8, 2014
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.
EXECUTIVE INTERVIEW - EMD Millipore: Enhancing the Bioavailability of Active Pharmaceutical Ingredients January 8, 2014
Drug Development Executive: Steffen Denzinger, Head of Portfolio Development at EMD Millipore, talks about bioavailability challenges and how EMD Millipore’s formulation portfolio and expertise are helping the pharmaceutical industry achieve maximum efficacy with APIs.
ADVANCED DELIVERY DEVICES - The Reconstitution Revolution October 15, 2013
Alan Shortall believes with dual-chamber syringes and other emerging device technologies now addressing key market requirements for intuitive reconstitution and injection, the pharmaceutical market for therapies suitable for reconstitution and mixing at the point of delivery is poised for significant rates of growth.
Foamix Unveils Cutting-Edge Technology Platform for Enhanced Delivery August 6, 2013
Foamix Ltd. recently announced the development of a new breakthrough platform technology for targeted drug delivery that can enhance the...DELIVERY DEVICES - The New Industry Paradigm for Prefilled Success March 12, 2013
Alan Shortall indicates that following a period of relative industry stability defined by peripheral innovation, a converging series of external and internal forces are set to reshape the prefilled syringe industry so that it will better serve the emerging needs of pharmaceutical companies, patients, and other stakeholders across the continuum of care.
DRUG DELIVERY - Oral Delivery of Peptides by Peptelligence Technology March 12, 2013
William Stern, PhD; Nozer Mehta, PhD; and Stephen Carl, PhD; review a highly developed, clinically proven platform technology that enables the oral delivery of peptides, overcoming the hurdles inherent to oral peptide delivery.