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.

Solution

Digital CDMO

Industry

Pharma / Biotech

Scope

Process Orchestration / PAT Modeling / Automation / Data Science

Timeframe

4 months

60%

experiment reduction time

80%

manual process steps removed

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

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.

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 — 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.

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.