Vcaps® Enteric is a fully compliant capsule technology that simplifies drug enteric delivery implementation from early stage development to commercial manufacturing. Vcaps Enteric capsules have been evaluated in-vitro and in-vivo across a number of compounds, and have proven full compliance with relevant EP, JP and US Pharmacopeia monographs. By removing the need for enteric coating, Vcaps® Enteric capsules offer tremendous potential in early stage product development, greatly simplifying formulation and process development as well as scale-up and validation. Intrinsically enteric capsule technologies also provide product differentiation and life cycle management opportunities.
Company name: Capsugel
Website: www.capsugel.com/biopharmaceutical-products/vcaps-enteric-capsules
E-mail: solutions.emea@capsugel.com
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Transformations in Drug Development for Cell and Gene Therapies
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.
Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang
March 28th 2025As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.