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SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product June 1, 2022
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
UK Government to Support Expansion of Croda’s Lipid Systems Manufacturing Facility April 4, 2022
Croda International Plc that uses smart science to create high performance ingredients and solutions that improve lives, recently announced that it has been awarded a £15.9 million grant by the UK Government to expand….
Hovione & Zerion Pharma Announce Strategic Partnership February 22, 2022
Hovione recently announced a strategic partnership with Zerion Pharma to market and commercialize Dispersome, Zerion´s proprietary solubility enhancement….
Novavax & Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia November 1, 2021
Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) recently announced that the National Agency of Drug and Food...DRUG DELIVERY - CAPRO(TM): A New Advance in Polymeric Drug Delivery October 4, 2021
Bob Wieden and Chun Wang, PhD, discuss how significant challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel polymeric drug delivery platform that overcomes a great many bioavailability and delivery obstacles.
FORMULATION FORUM - Age-Appropriate Pediatric Formulation Development November 23, 2020
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development August 24, 2020
This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules June 4, 2020
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
PFS MANUFACTURING - Prefilled Syringes & Biologics: The Perfect Partnership of Medicine & Delivery June 4, 2020
Anish Parikh charts the twin rise of biologics and PFS, outlines some of the common challenges associated with filling and dispensing, and discusses how a patient-centric partnership approach can help biopharmaceutical companies shorten the development pathway and ensure a reliable supply of safe, effective medicines for the people who need them.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services June 5, 2019
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
Industry Trends: Vigilance is Critical for Future Success April 8, 2019
Peter Soelkner says there will always be a wide variety of trends influencing our industry and we see no reason why this will not continue well into the future.
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.
Croda Acquires Biosector; Strengthens Pharmaceutical Offering December 17, 2018
Croda International Plc, the speciality chemical company that creates high performance ingredients and technologies relied upon by industry and consumers globally, recently announced that it has strengthened its pharmaceutical offering by signing a definitive agreement with Brenntag Nordic A/S to acquire Brenntag Biosector (Biosector).
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Are Innovating for 21st-Century Medicine June 6, 2018
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs about the innovations they are developing for next-generation patient care, and how many are making investments that are enabling them to offer more services under one roof.
Lubrizol Invests $60 Million to Expand Particle Sciences, Vesta & Other Facilities June 6, 2017
The Lubrizol Corporation recently announced its LifeSciences business continues to invest in its key capabilities through a variety of planned...Lonza to Acquire Capsugel to Create Leading Integrated Solutions Provider to the Global Pharma & Consumer Healthcare Industries December 14, 2016
Lonza Group AG, KKR, and Capsugel S.A. recently announced they have entered into a definitive agreement under which Lonza will...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.
FORMULATION DEVELOPMENT - Interactive Web Tool Helps Innovators Match Formulations to Drug Delivery Technologies January 7, 2015
Kurt Nielsen, PhD, explains how an interactive web tool designed to help innovators match formulations to drug delivery challenges allows users to assess multiple oral drug delivery technologies in order to establish which may be the most appropriate for their molecule.
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 - Prefilled Syringes & Parenteral Contract Manufacturing - Product Differentiation Is Critical May 8, 2014
Contributor Cindy H. Dubin speaks with several of these suppliers and manufacturers about the importance of customization and differentiation as the key to pharma companies staying competitive in the prefilled syringe space.