Chinese chromatography resins can replace imported products in many development and manufacturing settings, but substitution is not a property printed on a datasheet. It is a conclusion earned at thr…
Artificial intelligence can accelerate chromatography resin selection, but it cannot infer a universally “best resin” from catalog specifications. The practical route is a closed evidence loop: gener…
AAV, plasmid DNA and mRNA cannot be purified by simply shrinking or enlarging a monoclonal-antibody platform. Their size, surface charge, topology, shear sensitivity and product-related impurities ch…
The least expensive chromatography resin is not the resin with the lowest price per liter. It is the resin–process combination that delivers the lowest cost per accepted batch or per gram of released…
Moving from batch chromatography to periodic counter-current chromatography (PCC) changes the resin-selection question. The best batch resin is not automatically the best continuous resin: the rankin…
A conventional IgG platform is a useful starting hypothesis—not a transferable process. Bispecific antibodies, antibody–drug conjugates (ADCs), Fab/scFv fragments and Fc-fusion proteins can differ in…
Mixed-mode chromatography can sometimes collapse two purification operations into one—but only when its additional selectivity survives the real feed, recovery target, hydraulic limits and lifecycle…
Ion exchange chromatography (IEX) is often described as a choice between CEX and AEX. In practice, the useful question is more specific: which charge interaction, operating mode and buffer window wil…
This article proposes a practical benchmark for modern antibody manufacturing. It distinguishes peer-reviewed studies, a biopharma-authored industry case study, regulatory guidance and supplier speci…
Selecting a chromatography resin is not a catalog-matching exercise. It is a separation-design problem: the target molecule, the impurities that must be removed, the operating window and the bioproce…
Cytiva part number AB1USV47PH4 is a 10-inch Pall™ Pegasus™ SV4 virus-removal cartridge: a direct-flow, nominal 20 nm, hydrophilic modified-PVDF filter with a Pall Code 7 bayonet/fin connection, two s…
Choosing between in-house and outsourced IVD reagent manufacturing is not a one-time make-or-buy calculation. You are choosing where process knowledge lives, who absorbs demand volatility, how quickl…