BIOne—The Simplest Single-Use Bioreactor System on the Market Today!
You don't need to make a large capital investment to convert your existing benchtop glass bioreactor to a single-use bioreactor. Simply remove your existing headplate and place the preassembled and sterile Distek BIOne System into the glass vessel. The "patent pending" bioreactor liner will mold to and mimic your existing glass system allowing you to continue using your existing cabinet, probes, motor, heating blanket, water jacket and recipes. Since the liner is identical to the dimensions and aspect ratio of your existing vessel, there is no need to change your process. All materials are USP Class VI, animal derivative free and utilized in existing single-use products. Distek, Inc.
www.distekinc.com
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Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
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.
