We have expanded our service offerings to include potency testing for veterinary pharmaceuticals under veterinary Good Manufacturing Practice (GMP) license according to Art. 88 of Regulation (EU) 2019/6. Meet regulatory requirements and ensure that your veterinary products are both safe and effective for use in animals.
We offer both in vitro and in vivo assay development and validation to ensure precise and reliable results, tailored to your specific product needs.
Over the years we have developed a range of customized, product specific, potency assays in accordance with US Food & Drug Administration (FDA) and the European Medical Agency (EMA) standards, as well as guidelines issued by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
We conduct routine potency testing for hormones, vaccines, antibodies, and other veterinary products, adhering to GMP standards to guarantee quality and accuracy.
We use state of the art, highly sensitive HPLC equipment to conduct qualitative and quantitative analysis under both GMP and non-GMP conditions.
Our facility performs in vivo and in vitro Good Laboratory Practice (GLP) testing to support preclinical and clinical research, ensuring full compliance with regulatory requirements.
Our BioPharma Efficacy team specializes in the characterization of monoclonal antibodies, hormones, and cytokines. We also have extensive experience working with biosimilars or modified biologics, such as pegylated products. Our BioPharma Safety assays are designed to help you mitigate off-target interactions of your drug candidate and to achieve optimal specificity from your new drug.
Our in vitro functional bioassays provide critical insights into the biological activity of your products, ensuring they meet efficacy and safety standards.
Discover our standardized safety assay formats for chemical and cosmetic products.
We offer in vivo, in vitro, and ex vivo immunotoxicity evaluations to assess the potential immunological impact of veterinary products, helping to safeguard animal health.
Our BioPharma Efficacy team specializes in the characterization of monoclonal antibodies, hormones, and cytokines. We also have extensive experience working with biosimilars or modified biologics, such as pegylated products. Our BioPharma Safety assays are designed to help you mitigate off-target interactions of your drug candidate and to achieve optimal specificity from your new drug.
As part of our expanded GMP-certified quality control testing capabilities, we are now equipped to provide comprehensive in vivo and in vitro bioanalytical testing across a range of products, including:
A wide range of validated analytical packages, including rituximab, trastuzumab, adalimumab, infliximab, and etanercept.
Testing solutions using a variety of target cell lines, reporter-genes and primary cell-based assays.
GMP certified analytical methods to validate the biological activity of your hormones. Discover our analytical packages including, hGH as well as cGMP compliant in vivo analysis for Follicle Stimulating Hormone (FSH), Luteinising Hormone (LH) and Human Chorionic Gonadotropin (HCG).
These services are meticulously designed to assist animal health companies in meeting regulatory requirements and ensuring that their products, including hormones, vaccines, and antibodies, are both safe and effective for use in animals. Our team of experienced study directors, scientists, and technicians is deeply knowledgeable in GMP protocols and dedicated to delivering accurate, reliable results that you can trust.
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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