1、Biopharma DownstreamCritical Process ParametersWhite Paper2White Paper|Biopharma Downstream Critical Process ParametersContent1.Focus:PATDownstream _ 42.PAT for Biopharma _ 63.From Critical Quality Attributes to Critical Process Parameters of DSP Process _ 104.DSP Operation Units Overview:Skid Train

2、 _ 135.Operation Units Critical Process Parameters _ 175.1 Buffer Preparation 175.2 Purification Part I:Chromatography 235.3 Purification Part II:Concentration and Filtration 275.4 Viral Inactivation 305.5 Additional Unit Operations I:Centrifugation 335.6 Additional Unit Operations II:Refolding 346.

3、Conclusions _ 357.References _ 36#1 CQA,CPP,KPI _ 5#2 PAT In-line/At-line/Off-line _ 8#3 Skid&Skid Train _ 13#4 Batch vs.Continuous/Single-Usevs.Reusable _ 16#5 On-Demand Buffer Dilution At Point of use _ 18#6 pH and Conductivity Dynamic Measurement _ 21#7 Single-Use Skid for LPLC Chromatography _ 2

4、6#8 Tangential Flow Filtration _ 28#9 Endogenous and Adventitious Viruses _ 31Info/examples boxes3White Paper|Biopharma Downstream Critical Process ParametersAbstractBiopharmaceutical downstream processing(DSP)plays a crucial role in the separation,purification,and formulation of therapeutic protein

5、s and other active pharmaceutical ingredients(API).This white paper provides an overview of the key units in DSP skid train,including chromatography,ultrafiltration/di-afiltration,viral inactivation,and optional operations like centrifugation and refolding.Critical process parameters(CPPs)associated

6、 with each operation are discussed,along with the analytical process sensors used to monitor parameters.Both reusable and Single-Use technologies are presented,high-lighting their respective advantages and applications.By understanding the relationship between CPPs and desired product quality attrib