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In the downstream purification process of antibody products, the clarification following Low pH virus inactivation is a highly challenging critical step. The feed liquid at this stage typically exhibits characteristics such as high turbidity, high viscosity, and complex impurity composition. In particular, the issue of host cell protein (HCP) residues not only affect the service time of subsequent chromatography resins but also directly affect the purity, safety, and efficacy of the final products.
Why is HCP Difficult to Remove and How to Achieve Efficient Clarification while Simultaneously Enabling Removal of HCP?
Host Cell Protein (HCP) refers to impurity protein produced by host cells during antibody expression. These proteins exhibit extensive diversity and significant variations in physicochemical properties (such as molecular weight, isoelectric point, and hydrophobicity). Some HCPs share highly similar physicochemical properties with the target antibody, making specific separation particularly challenging.
With the popularity of high-density cell culture technology, the initial concentration of HCPs in cell culture fluid has increased substantially. Even after efficient clearance steps, the absolute residual quantity may still impact downstream processes and product quality. Particularly after Low pH virus inactivation, the dramatic changes in solution environment can easily induce HCP aggregation or denaturation, forming particles of varying sizes or colloidal precipitates that significantly increase the difficulty of clarification filtration.
If not thoroughly removed, residual HCPs may potentially induce immunogenic responses, compromising product safety and long-term stability.
In response to this challenge, Cobetter launches Claricap® 0102XS depth filters, providing efficient clarification solutions. Specially designed for demanding fluid environment in bioprocessing, Cobetter Claricap® 0102XS depth filter employs a unique formulation and gradient pore size structure. It demonstrate good filtration performance and excellent impurities retention capabilities during the clarification step after Low pH, anClaricap®d enabling deep removal of HCP.
Recently, we evaluate the Claricap® 0102XS in multiple process assessments for [mAb/bispecific antibody] projects. The results are as follows:
Case Study 1
Case Study 2
Case Study 3
Following the Low pH treatment, the material with a turbidity of 250-300 NTU was used to evaluate and compare three different series of depth filters from Cobetter. The data are as follows:
Key Benefits of Using Cobetter Claricap® 0102XS Depth Filters
Higher HCP Removal Rate:
After filtration by Claricap® 0102XS, the HCP content in the post-Low pH feed liquid is significantly reduced, achieving an average removal rate of over 90%. This notably alleviates the purification burden on subsequent chromatography steps.
Excellent Filtration Flux and Loading Capacity:
Under optimized process conditions, the Claricap® 0102XS demonstrates a capacity of up to 200 L/m² for materials with high solid content, ensuring cost-effectiveness for large-scale production.
Superior Filtrate Quality:
For high turbidity feed liquid (>200 NTU), the post-filtration turbidity is reduced to <10 NTU, providing high-quality input for downstream processes. Additionally, the product exhibits low binding to target antibodies, effectively ensuring high product recovery.
What is the Filtration Mechanism Behind the Efficient Capture of HCP by Depth Filters?
Cobetter Claricap® 0102XS employs a multi-level depth filtration design that efficiently captures HCP through physical adsorption and electrochemical interactions:
Physical Retention Mechanism:
A multi-layer fiber matrix forms a multidimensional mesh structure that precisely captures particles of varying sizes (including denatured HCP aggregates).
High Dirt-Holding Capacity:
The gradient density structure enables sequential retention of impurities with different particle sizes, effectively delaying membrane fouling and significantly increasing loading capacity.
Precise Impurity Adsorption:
The specially designed filter media exhibits high-selective adsorption capacity for HCP and other impurities. The medium surface is specially modified with optimized charge density, enabling adsorption of charged HCP—particularly impurities with obviously charged characteristics after Low pH treatment. Additionally, specific adsorption media with high affinity for common HCP components (such as phospholipases, histones, etc.) achieves targeted removal.
Applications of Claricap® 0102XS Depth Filters
- Clarification after Low pH virus inactivation for biopharmaceuticals such as mAb and bispecific antibodies
- Remedial filtration for processes with high risk of HCP residue
- Downstream process upgrades for pursuing higher purity
Conclusion
Cobetter Claricap® 0102XS is not merely a high-efficiency depth filter, but a strategic partner in optimizing downstream processes and enhancing product quality. Its unique architectures enables efficient solid-liquid separation and deep removal of impurity. This significantly improves the purity and safety of antibody products, making it an ideal solution for complex processes.
By implementing Claricap® 0102XS in your post-Low pH clarification step, you will achieve:
- Enhanced Purification Efficiency: Reduced burden on downstream chromatography columns, extended resin lifespan, and lower production costs.
- Guaranteed Product Quality: Effective control of critical impurities like HCP, mitigating immunogenicity risks in the final product.
- Optimized Process Flow: Simultaneous clarification and primary purification through single-step filtration, simplifying operations and improving production efficiency.
