We summarize frequently asked selection criteria and regulations in biopharmaceutical manufacturing processes, based on published regulations, standards and papers. Each article cites its sources and states the date it was reviewed.
In the TFF (tangential flow filtration) step after purification, you need to set the membrane molecular weight cut-off, operating pressure (TMP) and crossflow rate, the number of buffer exchanges (diavolumes), the concentration at which to exchange, and the final volume and recovery method. We have also summarized, from public sources, how pH and excipients can drift from target at high concentration, and how to check membrane cleaning and reuse.
Read ›A bacterial endotoxins test (BET) result can be trusted only when the choice of technique, the endotoxin limit and maximum valid dilution, the test for interfering factors and formulation-related low recovery are considered together. Recent changes, such as new chapters for recombinant reagents and the removal of the rabbit pyrogen test from the European Pharmacopoeia, are summarized from public sources.
Read ›Protein A resins cannot be compared on price per liter or catalog binding capacity figures alone. You need to look together at binding capacity measured at the same residence time and breakthrough criterion, cleaning resistance and lifetime, impurity removal, cost per g of antibody, and regulatory documentation.
Read ›This guide sets out what to check when choosing a cryopreservation solution for cell therapy manufacturing, in this order: DMSO concentration and infusion reactions; animal-derived components; classification as ancillary material or excipient and qualification; freeze and thaw evaluation; and containers, stability and supply changes. All content is limited to what we confirmed directly in regulatory documents and peer-reviewed papers.
Read ›Based on the original documents, this guide explains which documents recommend "10 ng/dose" and "approximately 200 bp" for residual host cell DNA and with what scope, and why there is no uniform numerical limit for host cell protein (HCP). It also covers what to check when choosing qPCR and ELISA test methods.
Read ›This guide covers the main documents to request from suppliers when adopting a single-use system, what each document shows, and the regulations and standards behind them. Supplier data is input for the user's risk assessment, and responsibility for the assessment lies with the drug manufacturer.
Read ›A sterilizing-grade filter is defined not by its pore size rating but by a bacterial challenge test and process-specific validation. Based on the original regulatory documents, this guide covers what to check at the selection stage: the grade definition, material compatibility, integrity testing, sizing and supplier documentation.
Read ›This article is a reference summary of published regulations, standards and papers, and does not recommend any particular product. When applying it to an individual process, follow the latest original text of the relevant regulation and the review of your quality unit. Operated by B2BIO Inc., Bioprocess Division · Report content errors to info@b2bio.co.kr
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