Automated Cell Line Control with Advanced PAT

Industry

Pharma / Biotech

Scope

Process Orchestration / PAT Modeling / Automation / Data Science

Timeframe

4 months

  • 60%

    experiment reduction time

  • 80%

    manual process steps removed

  • 6

    standalone equipments integrated

01

CLIENT

A leading biopharmaceutical innovator focused on advanced monoclonal antibody (MAb) production and the implementation of state-of-the-art perfusion bioprocessing.

02

BUSINESS NEEDS

The client aimed to build a state-of-the-art perfusion cell line for MAbs to increase overall product quality. This required deep collaboration with vendors to develop new Process Analytical Technology (PAT) methods and a thorough understanding of the commercialization potential of integrated lab setups.

03

CHALLENGE

To help our client achieve data unity, we overcame the following challenges:

  1. Source Heterogeneity

    Quality Management
    Increasing product (MAb) quality by actively managing complex protein glycosylation profiles.

  2. Regulatory Compliance

    Complex Automation
    Automating a perfusion bioprocess that leverages advanced liquid chromatography and mass spectroscopy (LS/MS) PAT models.

  3. Restrictive Environment

    Interdisciplinary Coordination
    Managing multiple streams of work across process research, data analytics, and system integration.

  4. Validation Continuity

    Distributed Collaboration
    Coordinating efforts across a distributed team located in multiple sites across the EU and USA.

Digital lab integration showing the secure connection between physical laboratory instruments and a centralized data management system.

04

SOLUTION

We delivered a fully integrated laboratory ecosystem that utilizes a central process orchestrator and closed-loop control to stabilize MAb glycosylation profiles. The solution entailed:

  • Advanced Data Platform
    • Creation of a centralized data platform with advanced visualization capabilities to monitor process parameters.
  • Central Process Orchestration
    • Implementation of a Process Orchestration Layer (POL) to manage the entire lab cell line.
  • Closed-Loop Control
    • Development of an automation framework based on integrated PAT models to enable real-time process adjustments.
  • Team Integration
    • Deployment of a specialized team of scientists, engineers, and technicians to handle complex technical requirements.

Łukasz Paciorkowski, A4BEE CEO

Achieving high-quality monoclonal antibody production at scale requires more than just advanced hardware; it demands the perfect orchestration of data, science, and automation. By integrating state-of-the-art LS/MS glycosylation profiling with a central Process Orchestration Layer, we moved from simple monitoring to true closed-loop control. This project highlights our ability to manage multiple complex workstreams, from deep process research to global system integration, ensuring that every technical hurdle is transformed into a quantifiable increase in product quality and operational efficiency.

Łukasz Paciorkowski

CEO A4BEE

Technology used

Central Process Orchestrator (POL) LS/MS Glycosylation Profiling PAT Modeling & Analytics Perfusion Bioreactor Control Aseptic Auto Sampler Closed-loop Automation

05

OUTCOME

The implementation successfully transformed a complex, manual research process into a fully integrated, high-precision bioprocessing environment. By closing the loop between analytical data and process control, we delivered a system capable of autonomous process parameters optimization.

  • Real-Time Quality Assurance
    • Active management of protein glycosylation profiles resulted in MAb consistency meeting the highest pharmaceutical standards.
  • Operational Autonomy
    • Transitioning to closed-loop automation reduced manual sampling, minimizing contamination risks and human error.
  • Accelerated Research
    • Harmonizing the lab cell line through a central orchestrator allowed for faster experiment iteration and reliable data correlation.
  • Commercial Readiness
    • Provided a scalable blueprint for perfusion bioprocessing, offering a clear path for global commercialization.

06

IMPLEMENTED SOLUTION

  1. Automated Perfusion Control

    Automated Perfusion Control Real-time management of bioreactor parameters based on sampling data.

  2. Aseptic Sampling Integration

    Aseptic Sampling Integration Seamless connection between the auto-sampler and analytical instruments.

  3. PAT-Based Model Integration

    PAT-Based Model Integration Using advanced data models to drive the Process Orchestration Layer.

  4. Global Project Management

    Global Project Management Execution through a distributed EU/USA team across multiple work streams.

  • 60%

    experiment reduction time

  • 80%

    manual process steps removed

  • 6

    standalone equipments integrated

Ready to implement closed-loop control in your bioprocess? Select your area of interest below, and let’s turn your complex PAT data into a competitive quality advantage.

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