Automating Cell Therapy Manufacturing

Chronicle is a GMP-compliant, fit-for-purpose digital solution developed by Cytiva to optimize complex cell therapy process development and manufacturing.

It connects Cytiva and third-party cell therapy instruments through a unified platform, supporting the full journey from early process development through commercial GMP manufacturing.

The platform provides electronic batch records, instrument scheduling, deviation management, and supply chain traceability - all independently audited against GAMP5 standards and compliant with 21 CFR Part 11 (FDA) and EU Annex 11 (EMA).

My role

I contributed to the front-end development of Chronicle, building key interfaces for instrument management, facility monitoring, and electronic standard operating procedures (eSOPs).

Instruments Overview

The main dashboard displays all connected instruments across two categories:

• Cytiva Instruments: Xuri Wave, Sofia, Sepax, AKTA Avant, AKTA Pure, VIA Freeze Quad, VIA Freeze Duo, VIA Freeze, VIA Thaw CB1000, GE Shipper
• 3rd Party Instruments: Incubator, Fridge, Bio safety cabinet, Cell Counter, Monitoring device, Flow Cytometer, Storage Freezer, HPLC

Each instrument card shows its current unit count in real time. The header bar provides a summary of customer trials, pre-GMP organisations, GMP organisations, and total credits remaining - giving managers an instant overview of capacity.

Equipment List

The equipment list provides a sortable, searchable table of every registered instrument across all demo pools and organisations. Each row surfaces:

• Instrument name and nickname
• Device type
• Serial number
• Organisation and instance
• Current status (e.g. ready_to_use)

This centralised registry eliminates spreadsheet-based asset tracking and provides a single source of truth for all lab instruments.

Instrument Detail View

The equipment detail page aggregates all data related to a single instrument:

• Cumulative runtime counter
• Data points collected
• Service records with last serviced date
• Alarms with delta over the last 3 months
• Serial number, device type, organisation, software version, and creation date

Operators can trigger a ServiceMax ticket, open a Remote Login session to the instrument directly, or switch the instance to GMP mode - all from the same screen.

A Connectivity panel shows authentication tokens and the Chronicle Gateway folder path, making it easy to diagnose integration issues without leaving the UI.

Real-time Operations View

The home screen for GMP operators combines three panels:

• Map view: displays the physical location of the manufacturing facility, providing geographical context for multi-site deployments
• Work queue: lists all active and pending eSOPs with start dates, allowing operators to pick up tasks and track progress
• Activity stream: a live feed of instrument connection events and status changes across all registered devices

New shipments can be initiated directly from this screen, and eSOPs can be started with a single click - reducing the friction between planning and execution.

Floor Plan Monitoring

The facility dashboard renders a floor plan of the manufacturing space with each connected instrument pinned to its physical location. Instruments in a warning state are highlighted in orange with a warning banner at the top of the screen.

Each pin displays live sensor readings (temperature, CO₂ levels) and current status, allowing facility managers to spot environmental deviations at a glance without walking the floor.

This view integrates with the alarm and deviation management system, so clicking a warning pin opens the relevant deviation workflow directly.

Electronic Standard Operating Procedures (eSOPs)

Chronicle replaces paper SOPs with guided, digital step-by-step procedures. Each eSOPs task:

• Locks steps sequentially to enforce correct execution order
• Embeds photographic references of instrument displays to guide operators
• Records completion timestamps and operator identity for audit trail
• Supports deviation notes per task

This approach ensures every operator follows the exact same procedure every time, regardless of experience level, and produces a complete electronic record compliant with GMP requirements.

Chronicle, it is

• A GMP-compliant Manufacturing Execution System (MES) for cell therapy
• Electronic batch records audited against GAMP5
• Compliance with 21 CFR Part 11 and EU Annex 11
• Integration with Cytiva and third-party instruments
• Instrument scheduling, deviation management, and supply chain traceability
• Real-time facility monitoring via interactive floor plans
• Guided eSOPs with full audit trail

Technology: Ruby on Rails / React / PostgreSQL / Docker / REST APIs