Search Results for: FORMULATION DEVELOPMENT A QbD Approach
Articles
SPECIAL FEATURE - Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results January 14, 2020
Contributor Cindy H. Dubin, in her latest report, describes some novel analytical testing services aimed at ensuring quality and safety, and in some cases, speeding the process and saving money.
White Paper: Control of Beta-Glucans & Endotoxin in High Purity Sucrose for Biopharmaceutical Applications October 16, 2019
This white paper discusses a Quality by Design (QbD) scenario that allows end users to rationally select the well characterized excipients during biopharmaceutical development and develop a control strategy for biologic drug products.
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.
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.
ORALLY INHALED PRODUCTS - Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products April 3, 2018
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
SPECIAL FEATURE - Analytical Testing - Contractors Take on the Challenge of Complex Molecules January 9, 2018
Contributor Cindy H. Dubin highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.
West Highlights Rigid Needle Shields for Prefilled Syringes June 20, 2017
West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, provided more information on...SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: A Rise in Biologics & Improved Technology Give Pharma Reasons to Consider Parenteral Delivery May 2, 2017
Contributor Cindy H. Dubin speaks with some of the leading companies in this market to find out about key trends, packaging advancements, safety improvements, and technology developments.
SPECIAL FEATURE - Analytical Testing: Market Drivers, Growing Demand & Client Needs January 17, 2017
Contributor Cindy H. Dubin spoke with several testing providers to find out what services they offer, trends they identify, and how they have specifically addressed clients’ needs throughout the past year.
SPECIAL FEATURE - Injectable Drug Delivery: Key Trends Define Device Design Now & in the Future August 31, 2016
Contributor Cindy H. Dubin spoke with some of the world’s leading device developers about their current injection technologies and how their devices are addressing the current trends and opportunities in the industry.
SPECIAL FEATURE - Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality June 2, 2016
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges May 2, 2016
Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.
DPT & Confab Complete $10-Million Capital Investment March 15, 2016
DPT Laboratories, a contract development and manufacturing organization (CDMO) specializing in semi-solid and liquid dosage forms, and Confab, a DPT...SPECIAL FEATURE - Analytical Testing: Using More Sophisticated Tools to Support Small & Large Molecule Projects January 8, 2016
Contributor Cindy H. Dubin recently spoke with leading analytical testing providers to find out what services they offer and what equipment they use to handle both small and large molecules for their pharma clients.
SPRAY-DRIED DISPERSIONS - Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions September 1, 2015
Devon DuBose, Dana Settell, Nathan Bennette, and Amber Broadbent, PhD, say drug pipelines increasingly feature new drug candidates that exhibit poor solubility and require well-established enabling technologies to address this critical issue.
HOT MELT EXTRUSION - OptiMelt™ Hot Melt Extrusion Technology to Improve Bioavailability of Poorly Soluble Drugs August 31, 2015
Sampada Upadhye, PhD, indicates bioavailability enhancement with formulation and dose form flexibility can be achieved through the application of HME technology to produce stable drug formulations and increased development success rates.
Patheon Adds Complex Solubility Expertise With Acquisition of Agere March 9, 2015
Patheon, a leading global provider of high-quality drug development and delivery solutions to the pharmaceutical and biopharma sectors, has reached...GLOBAL DELIVERY MARKET - Advanced Drug Delivery Systems: mAb, RNAi, & Breaking the Blood-Brain Barrier November 19, 2014
Kevin James, Shalini Dewan, MS, Kim Lawson, and Usha Nagavarapu believe advances in understanding human biology and diseases are opening new and exciting possibilities in the biotechnology industry. R&D spending, along with increasing competition, patent expiries, and new and emerging technologies will continue to shape growth in this market for the foreseeable future.
Changes & Trends in Solubilization Outsourcing October 9, 2014
By: Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc. Approved drugs over the last thirty-five years are...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.
Lyophilization Development: Quality by Design Approach
Lyophilization, or freeze-drying, addresses stability challenges associated with complex APIs, biologics, microbiomes, gene therapies, viral vectors, liposomes, and nanoparticles……
