Analytical Services

Analytical testing is a vital part of ensuring ATMP safety, identity, purity, and consistency. We support early-stage developers with fee-for-service testing today, and will expand to full QC capabilities from H2 2027.

Compendial safety testing
Cell line authentication
Advanced molecular analytics

Let's discuss how we can support you with analytical services!

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Analytical Services That Grow With Your Needs

In addition to analytical development, we perform fee-for-service safety testing and cell line authentication in our development lab. We will offer the same services for release in our GMP QC Lab starting in 2027.

In addition, through our collaboration with Precision BioAnalytics, we offer access to highly advanced expertise in molecular assay development and workflow optimization leveraging proprietary methods for unparalleled precision and sensitivity.

Tailored to Address Key ATMP Needs

Our analytical services address key needs in ATMP development. They help you manage risks and build confidence as your therapy progresses.

Safety Testing

Compendial tests for sterility, mycoplasma, and endotoxin confirm compliance with essential safety requirements.

STR Analysis

STR profiling secures the identity and purity of your cell lines, reducing risks of cross-contamination.

Advanced Molecular Testing

PCR- and sequencing-based methods give sensitive insights into product consistency and regulatory readiness.

The Role of Analytical Services in ATMP Development

Analytical testing plays a crucial role in the development of Advanced Therapy Medicinal Products (ATMPs), where the complexity and variability of the products demand high precision and reliability in testing.

Compendial safety testing, such as sterility, endotoxin, and mycoplasma testing, ensures that products are safe for use, while cell line authentication provides confidence in the identity and purity of the cell lines used in manufacturing.

There is a need for alternative rapid safety testing methods to complement traditional methods. We have established PCR-based methods that deliver rapid results, without sensitivity loss.

Advanced molecular analytics, including ddPCR, offer critical insights into the molecular characteristics of ATMPs, supporting consistency and quality control throughout the development process.

Analytical Services help ensure the reliability, safety, and efficacy of ATMPs as they progress through development stages, from pre-clinical research to GMP manufacturing.

Our Tests & Methods

Our analytical services use state-of-the-art pharmacopeial methods to meet regulatory standards for safety, purity, and identity. We provide robust data packages suitable for submissions and will expand to a full QC suite with our new GMP facility in Q2 2027. Until then, we deliver selected non-GMP services and additional services through our partnership with Precision BioAnalytics, offering expertise in molecular assay development and workflow optimization

Rapid Sterility Testing

We offer multiple methods for sterility testing. This includes culture-based assays for aerobic and anaerobic bacteria (BACT/ALERT®) compliant with EP 2.6.1, and rapid qPCR-based testing for bacteria and fungi (Microsart® ATMP) compliant with EP 2.6.26 and EP 5.1.6.
Mycoplasma Detection

To ensure your product is free from mycoplasma contamination, we use a highly sensitive dPCR-based method (QIAcuity Mycoplasma Quant Kit). This test adheres to EP 2.6.7, USP <63>, and JP <G3-14-170>.
Endotoxin Testing

We perform endotoxin detection using a modern Recombinant Horseshoe Crab Factor C (rFC) Assay. This method avoids the use of animal products and is fully compliant with EP 2.6.32, USP <86>, and JP <G4-4-180>.
Cell Line Authentication

We confirm the identity of your cell lines using STR profiling. This service uses direct-PCR amplification and Sanger sequencing across 16 markers, adhering to the ANSI/ATCC ASN-0002-2022 standard.

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