Our Service Offering

Bioanalytical contract research services to support your pipeline from discovery to approved product release testing.

We specialize in the development and validation of robust bioassays to evaluate potency and bioactivity of your compound.

Our services are performed under GMP and GLP certification to meet regulatory guidance for pre-market and on-market products.

BioPharma
Potency

We develop and execute potency assays for biologics, proteins, and active pharmaceutical ingredients under established quality guidelines.

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BioPharma Efficacy & Safety

We work with you to establish efficacy models to test your biosimilar or API and offer a variety of safety assessment studies to support your product registration.

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Physico – Chemical Analysis

We use state of the art, highly sensitive HPLC equipment to conduct qualitative and quantitative analysis under both GMP and non-GMP conditions.

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GLP Offering

We support your compound selection before registration with complementary in vitro/in vivo acute toxicity and skin sensitization services.

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Expertise

Experienced team, focus on your needs, customizable assays

Bioanalytical assays are our core expertise. When you work with us you gain immediate access to our team of experts with focus and flexibility without long waiting lists.

Our Services

Discover our expertise

Assay
Development

We have developed potency assays for a variety of drug products and biologics, including proteins, monoclonal antibodies, vaccines, and gene therapies. Our team of experts will work with you to select the most appropriate assay format and design a robust and sensitive method.

Assay
Validation

We follow GMP guidelines to validate potency assays, including establishing accuracy, precision, linearity, and specificity. Our validation process is designed to ensure that the assay is reliable and reproducible, providing confidence in the potency results.

Release
Testing

We offer GMP potency testing for lot release, providing assurance that each batch of your product meets regulatory requirements for potency.

Stability
Studies

We have performed GMP potency assays on stability samples to monitor product potency over time and ensure that the product remains within specification throughout its shelf life.

Quality Assurance

Transparent and efficient quality system

Every aspect of our operations is governed by a robust quality system designed to meet regulatory requirements and maintain data integrity. We continuously improve our processes to deliver exceptional services and testing results you can rely on. Our assay qualification and validation services are performed under current Good Manufacturing Process (cGMP) to meet current standards for GMP product release. Additionally, we perform GMP batch testing to support your post-market release.

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Advanced Analytical Equipment

2000 m2 state-of-the-art facilities

Our in vitro and in vivo laboratories at Heidelberg Technology Park are equipped with state-of-the-art instruments to ensure the highest precision and efficiency in our assays and execute studies under highly controlled regimes.


Your Development Partner

Contact Us

Contact us to learn more about our assay development and testing services and how we can help you bring safe and effective drug products and biologics to market.

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NEWS RELEASE

Bioassay GmbH now part of Reaction Biology Corporation.

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