Search Results for: COMBINATION PRODUCTS 6 Guidelines to
Articles
SPECIAL FEATURE - Excipients: Enhancing the New, Poorly Soluble APIs June 1, 2015
Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.
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.
STANDARDIZATION TECHNOLOGY - Innovative Temperature Standardization Technology Supports Cell Therapy Clinical Trials March 2, 2015
Rolf O. Ehrhardt, MD, PhD, and Maria Thompson, PhD, discuss a unique proprietary temperature standardization technology that is practical for all stages of cell processing and handling. It is currently supporting a Phase IIb clinical trial investigating the efficacy of an immunotherapy treatment for patients with moderate-to-severe refractory Crohn’s disease.
SPECIAL FEATURE - Analytical Testing: A Critical Element in Drug Development January 8, 2015
Contributor Cindy H. Dubin interviews several industry experts who believe there is intense competition to develop cutting-edge therapies and get them through development quickly to take advantage of patent exclusivity. And one of the critical elements in the drug development process is analytical testing.
QUALITY-BY-DESIGN - Quality-by-Design: The Good, The Bad, The Inevitable October 2, 2014
Michael Lowenborg believes in essence, QbD can be interpreted as a way to maximize time and cost savings by better understanding the components and processes necessary to optimize a drug product’s safety, efficacy, and quality at every stage in development.
SPECIAL FEATURE - Injectable Drug Delivery: Safer, Simpler, Smarter Devices September 4, 2014
Contributor Cindy H. Dubin speaks with some of the leading companies operating in the injectables arena, and discovers this ever-evolving sector is witnessing some very specific and eye-opening trends that are affecting the market’s growth.
BioSpectra Offers Industry-Leading Custom Manufacturing Capabilities July 28, 2014
BioSpectra, Inc. recently announced its ability to offer contract manufactured products for pharmaceutical, biopharmaceutical, and drug manufacturing markets direct from...MARKET BRIEF - Sequestration Haunts Life Science Research Tool Market Into 2014 July 8, 2014
Christi Bird, Senior Industry Analyst, Frost & Sullivan, believes the bleakest outlook provided for the life sciences industry is one without a clear light at the end of the tunnel, and successful companies will buckle down to determine long-term strategies for beating the lackluster numbers expected from a sustained austerity policy.
FORMULATION DESIGN - Formulation of Poorly Soluble Drugs: A Modern Simulation-Based Approach May 7, 2014
Sanjay Konagurthu, PhD, and Alexander McVey, MS, present a case study in which a model BCS Class II compound, dipyridamole, was evaluated as an amorphous dispersion using molecular modeling combined with experimental data.
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.
PREFILLABLE SYRINGE TECHNOLOGY - BD Neopak - Delivering the Next Generation in Glass Prefillable Syringes January 8, 2014
Justin M. Wright, PhD, and Herve Soukiassian highlight significant development and commercial manufacturing investments in glass PFS container technology for the biotech industry with three key areas of focus: reducing overall variability, reducing SbVPs, and increasing glass strength and durability performance.
EXECUTIVE INTERVIEW - Aptar Pharma: From Self-Injection to Auto-Injection November 20, 2013
Pierre Carlotti, Vice-President of Marketing and Communication for Aptar Pharma Prescription Division, talks about the market for auto-injectors and some relevant market trends, and explains how his company went about designing and developing a novel auto-injector.
MARKET BRIEF - Financial Performance Benchmarking & Competitive Landscape Assessment of Leading CROs November 18, 2013
Adam M. Dion, MS, summarizes GlobalData’s recent CRO Benchmark Report and believes the dynamics of pharmaceutical outsourcing and location decisions in emerging markets are changing. Cost reduction is being augmented and will gradually be eclipsed by footprint growth as a major factor shaping decisions, and CROs are realizing that the ability to be on the ground closer to their customers is a key building block to establishing sustainable, long-term relationships with clients.
EXECUTIVE INTERVIEW - Vetter: Successfully Bridging the Innovation Gap in Drug Development & Manufacturing September 5, 2013
BIOGRAPHY Claudia Roth, PhD President, Vetter Development Service Chicago “We are noticing that CDMOs are acting more and more as...EXECUTIVE SUMMARY - Asmacure, Ltée: A New Mechanism for the Treatment for Asthma March 31, 2013
Executive Summary: Martin Driscoll, CEO of Asmacure, talks about his company’s unique, yet practical approach to treating asthma and its core symptoms.
2/20/2013 February 17, 2013
Argos Therapeutics Announces Updated Phase II Data Argos Therapeutics Inc. recently announced updated results from its Phase II study of...11/14/2012 November 8, 2012
A Note to The Pharmaceutical Industry Upon The Re-Election of Barack Obama By: Matthew Herper, Forbes Staff, mherper@forbes.com I've covered...Novartis Expects 14 New Blockbusters November 8, 2012
Novartis recently provided an update on its leading Research and Development (R&D) pipeline and plans for turning these assets into...8/15/2012 August 12, 2012
Quintiles Acquires Company to Advance Personalized Medicine Quintiles recently announced the acquisition of Expression Analysis, Inc. (EA), a premier provider...7/12/2011 July 6, 2011
Evotec & Roche to Jointly Develop Biomarkers in Oncology Evotec AG and Roche recently announced a collaboration in novel...
