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Automated Cell Line Control with Advanced PAT

Discover how we implemented automated cell line control with advanced PAT and Process Orchestration for a leading biopharma innovator, ensuring high-quality MAb production.

Industry

Pharma / Biotech

Scope

Process Orchestration / PAT Modeling / Automation / Data Science

Timeframe

4 months

Technology

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

60%

experiment reduction time

80%

manual process steps removed

6

standalone equipments integrated

The client

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

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.

The challenge

  • 01

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

  • 02

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

  • 03

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

  • 04

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

Our 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:

  1. Advanced Data Platform

    Creation of a centralized data platform with advanced visualization capabilities to monitor process parameters.

  2. Central Process Orchestration

    Implementation of a Process Orchestration Layer (POL) to manage the entire lab cell line.

  3. Closed-Loop Control

    Development of an automation framework based on integrated PAT models to enable real-time process adjustments.

  4. Team Integration

    Deployment of a specialized team of scientists, engineers, and technicians to handle complex technical requirements.

Technology used

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

The 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
  • Operational Autonomy
  • Accelerated Research
  • Commercial Readiness

What we implemented

  • Automated Perfusion Control Real-time management of bioreactor parameters based on sampling data.
  • Aseptic Sampling Integration Seamless connection between the auto-sampler and analytical instruments.
  • PAT-Based Model Integration Using advanced data models to drive the Process Orchestration Layer.
  • Global Project Management Execution through a distributed EU/USA team across multiple work streams.
Łukasz Paciorkowski
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

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