ADC Therapeutics SA is a commercial-stage biotechnology company headquartered in Epalinges, Switzerland. Founded in 2011 as a spin-off, ADC Therapeutics specializes in the development of antibody-drug conjugates (ADCs) for the treatment of hematologic malignancies and solid tumours.
With a workforce of over 270 employees and a strong research focus, ADC Therapeutics continues to advance innovative oncology therapies. As operations scaled, coordinating standard management and analytical standards through manual processes became increasingly challenging, leading the company to adopt AmpleLogic’s Standards Module for digital transformation.
Summary
ADC Therapeutics implemented AmpleLogic’s Standards Module to replace paper-based standards and test documentation with a centralized, digital, and validated platform.
The system unified equipment usage logs, reagent data, and analytical test records across departments, ensuring audit readiness and compliance with global data integrity standards. Through digital automation, ADC Therapeutics streamlined its standards with analytics, eliminated redundant manual work, and established real-time visibility into equipment and test performance.
Challenges Faced
- Frequent process changes required repeated updates and circulation of templates across departments.
- Manual data entry resulted in productivity loss, errors, irrelevant entries, and mismatched timelines.
- Difficulty in tracking “Quality Prepare” data, remaining quantities post-production or testing.
- Reagents and analytical data were recorded manually, hindering quantification and traceability.
- Missing signatures, overwriting, and illegible entries caused review challenges and non-compliance.
- Delays in audit preparation due to difficulty in locating the Standard Management Record
- Repetitive data entry across multiple logbooks consumed significant technician time.
Solutions Implemented
ADC Therapeutics adopted AmpleLogic’s Standards Module, covering multiple categories of reference and analytical standards:
- Primary Reference Standards: The highest benchmark materials ensuring precise calibration; directly used for quantifying unknown substances or validating analytical methods.
- Working Reference Standards: Secondary standards calibrated against primary standards for routine laboratory use, optimizing cost and consistency.
- Impurity Standards: Defined to detect and quantify related substances and degradation products in pharmaceutical formulations.
- Toxin Testing Standards: Validated assays to identify and measure toxins in compliance with global regulatory guidelines.
- Critical Reagents: Digitally controlled inventory and traceability of essential materials used in testing and manufacturing processes.
In addition, all analytical data were centralized within a validated digital framework, ensuring complete traceability and data integrity.
Results / Benefits
- 100% digital capture of calibration, test, and equipment usage data in a centralized system.
- Instant template updates ensure consistent documentation formats across departments.
- Automated data validation minimized errors and improved data reliability.
- Time-stamped, electronically signed records aligned with ALCOA+ data integrity principles.
- Role-based access control enabled secure, authenticated, and audit-ready documentation.
- Quantifiable reagent data are digitally tracked for accurate inventory and analytical traceability.
- “Quality Prepare” values are automatically calculated to reflect remaining quantities post-testing.
- Paperless workflows reduced manual effort and improved turnaround for maintenance activities.
- Full alignment with SOP and regulatory requirements for the standard with analytical testing.
Why ADC Therapeutics chose AmpleLogic?
ADC Therapeutics selected AmpleLogic for its:
- Proven expertise in validated digital systems for regulated life-science environments.
- Configurable modules tailored to calibration, analytical standards, and equipment management.
- Compliance with 21 CFR Part 11 and global data integrity expectations.
- Ability to scale with ADC Therapeutics’ growing research and manufacturing operations.
AmpleLogic’s Standards Module provided ADC Therapeutics with a compliant, audit-ready, and scalable digital platform that strengthened data integrity, reduced manual workload, and enhanced operational efficiency across standard management functions.
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