Partnering with Customers to Accelerate the Process Implementation — Case Sharing of BioLink Suzhou Application Center

Introduction: Taking Application as the Core, Empowering Process Innovation

In the process of biopharmaceutical R&D and manufacturing, how to balance the R&D cycle, process stability and scale-up is the key to the smooth implementation of customer projects. The BioLink Suzhou Application Center is based on these demands of the industry. Relying on complete upstream and downstream application platforms and expert resources, the center can not only provide customers with full-process support from lab scale, pilot scale to production scale, but also play an irreplaceable and important value in process optimization and project acceleration.

Platform Capabilities: Integrated Support, Covering Upstream and Downstream

BioLink Application Center covers an area of about 3,000 square meters, with R&D, application, cell culture and purification laboratories, equipped with advanced instrument, equipment and diversified reactor systems.

Figure 1: Laboratory area of Suzhou Application Center

The team has end-to-end process development and training capabilities from antigen design, cell culture, protein expression to chromatography purification, and has served various projects such as antibodies, vaccines, blood products, recombinant proteins and natural extracts. Whether it is process development, process transfer, or validation and optimization, the center can provide integrated solutions that take into account the depth of R&D and industrialization needs.

Figure 2: Services available from Suzhou Application Center

Introduction to Main Platforms

1. Upstream Fermentation

• Lab-scale Fermentation Process Platform (3 L/7 L glass vessel): 1-5L lab-scale process development and sample preparation.

• Rocking Culture Process Platform: 5-25 L scale sample preparation, seed preparation (200L).

• Transient Platform (CHO, HEK293): Rapid preparation of mg-grade samples.

• 50 L/200 L Fermentation.

2. Downstream Purification

• Purification Process Development: antibodies (monoclonal antibody/bispecific antibody/trispecific antibody), vaccines (VLP vaccines, subunits, etc.), blood products, recombinant proteins (collagen/others), etc.

• Match 50L/200L Sample Preparations.

• Resin Life Validation:

        1. Program formulation, implementation and results delivery process

        2. Equipment and documentation comply with PC requirements

        3. Experience with endotoxin control

Case Display: Value Realization from Demand to Results

In past project practice, Suzhou Application Center has helped customers continuously break through R&D bottlenecks and accelerate project advancement through solid technical capabilities and flexible solutions.

Case 1: Herpes Zoster Vaccine Process Scale-up

• Customer Requirements: Transfer the stainless steel bioreactor culture process to a 200L single-use bioreactor and optimize the purification process (purity > 99%, recovery rate> 25%).

• Suzhou Application Center Results: successfully reproduced and optimized the culture process in a 7L tank, with a cell density of 11 × 10⁶/mL and a protein expression of about 1.5 g/L; The optimized purity of the three-step chromatography process is > 99%, which meets customer needs and achieves scalable validation to 200L scale.

Key data during development are as follows:

Optimized Process Flow:

Cell Culture Process Flow

Purification Process Flow

Cell Culture Process:

Growth Metabolism Curve

Three-step Purification Chromatogram

Figure 3: MaXtar® Q anion exchange chromatogram

Figure 4: Phenyl Chromstar® HP hydrophobic chromatography

Figure 5: SP Chromstar® FF cation layer

Case 2:Purification Process Development of Human Recombinant Albumin

• Customer Requirements: Develop and validate pilot-scale process, requiring purity ≥ 98% and recovery rate of 45%-50%.

• Suzhou Application Center Results: completed process development and three process reproductions, the yield of the three batches is ≥ 45%, and the purity is ≥ 98%; And on-site guide customers to complete process reproduction. While helping customers improve process stability and repeatability, a more stable process system for customers has been established.

Key data during development are as follows:

Process Validation, Batch 1 as an example:

Three-step chromatography process

Figure 7: MaXtar® Q chromatogram

Figure 8: Chromatogram of Multimode Chromatography 1

Figure 9: MaXtar® MMC chromatogram

SDS-PAGE Detection

Case 3: Protein A Resin Life Validation

• Customer Requirements: Complete the life validation of the 200-cycle scaled-down model and comprehensively evaluate key process performance indicators such as binding capacity, purity, impurity control and yield during testing.

• Suzhou Application Center Results: After 200 cycles, DBC 10% remains above 80%, the recovery rate remains above 85%, and the product purity and HCP removal rate are stable. Help customers reduce long-term production costs and verify process economics.

Trend Analysis of Key Indicators

Case 4: Multimodel Protein Preparation

• Customer Requirements: Prepare collagen for resin testing, purity > 95%.

• Suzhou Application Center Results: 7 L of E. coli fermentation, collagen with purity > 95% was obtained through two-step chromatography, and the yield was about 8g. Quickly deliver high-quality test materials and shorten customer R&D cycles.

Key data during development are as follows:

E. coli Fermentation:

Growth Curve:

Purification Process

Cation Exchange Chromatogram

SDS-PAGE Detection:

Case 5: Transient Protein Expression

• Customer Requirements: Increase the expression level of Fc fusion protein and prepare 5-10mg samples with purity ≥ 95%.

• Suzhou Application Center Results: Using HEK293F transient expression system, combined with BioLink Protein A chromatography resin, the purity of the final product is ≥ 95% and the concentration reaches 1 mg/mL. Help customers quickly obtain high-quality samples in the early R&D stage.

Key data during development are as follows:

Plasmid Preparation

Advantages: A large number of plasmids can be prepared by chromatography, and the purity is higher.

Transient Expression and Purification

Continuous Innovation and Win-win Cooperation

Through a series of successful process development and optimization cases, BioLink Suzhou Application Center not only demonstrated its strong technical capabilities, but also reflected its value as a customer R&D accelerator and process innovation partner. In the future, the center will continue to rely on complete upstream and downstream application platforms to promote process innovation and help more customers achieve efficient transformation and industrialization of projects.