Assay Services

What We Do

 Anti-Drug Antibody (Immunogenicity) Assays

 Haemtech provides development and validation of assays to detect anti-drug (ADA) antibodies and to evaluate the immunogenicity of your therapeutic protein.   Additionally, you can rely on our experience to help you find or develop and manufacture the appropriate control or reference material for your assay(s).  In the end we will deliver a final product or process that meets all of your quality and regulatory requirements.

 Immunoassay Development

 If you require assays to detect or measure a specific target molecule in plasma, serum or alternate matrix Haemtech can develop an immunoassay for that purpose.  We can also assist in the development of specific monoclonal antibodies, and in the purification and characterization of the target antigen.  

Sample Testing

 We can take your investigation one step further by evaluating your samples using the newly developed assays.  Our staff of experienced technicians and Ph.D. biochemists will handle your research or clinical study proficiently from the beginning to the end, and all resulting data will be rigorously reviewed by the highly qualified and experienced members of our quality department.  You can rely on us to handle your samples and maintain your data in a manner that will ensure you receive results that are accurate, valid and secure.

 How We Do It

 Feasibility and Proposal

 Our staff will consult with you to identify the scope and needs of your project.  We will work through scenarios with you that achieve your goals based on your deadline.  Finally, you will be presented with a clear, easy to understand proposal complete with costs and timeline.

 Development, Optimization and Validation

 During development we evaluate candidate antibodies to select those that are the most efficacious, and also identify and/or create the appropriate standards and controls.  The impact of matrix effects are also studied to ensure effectiveness of the antibodies and proper identification of the analyte in its medium.  Finally, minimum dilution and assay cut point (if applicable) are determined.  Validation consists of stringent testing to make certain that your assay performs consistently and provides you with reliable results.  During this phase we will evaluate various parameters which may include assessments of accuracy, precision, selectivity, limits of detection, robustness and more depending on the specific needs.  When complete you can choose to transfer the technology to your facility or contract us to test samples for you.

 Sample Management

 Samples are stringently reconciled against documentation provided by the customer.  Any deviation between the samples and the documentation results in immediate sample quarantine until clarification is obtained from the customer.  All customer property is then maintained to protect against damage and contamination and to allow for appropriate tracking and usage.

 Safe and Secure

 You can rest assured that your samples and data are in good hands for the duration of your study.  Our safety program begins with our environmental monitoring system, which monitors all storage chambers and freezers where your samples are stored.  Temperature data is sent to a central server where it can be used to generate temperature charts.  In the rare chance that a storage device does go out of specification audible alarms alert on-site staff, and a call out system telephones a chain of individuals trained in making sure your samples stay in specification.  Back up storage devices are also in place in the event of a failure.  Should the power go out a back-up generator is activated creating virtually seamless interruption in storage device function.  Your data is similarly secured on multiple on-site servers that are maintained in a controlled environment, and with weekly off-site, secure storage of tape back-ups.

 Compliance

We are an ISO 9001:2000 registered facility, and follow FDA and EMEA guidelines for assay development and validation.  We can qualify and validate your assay to meet stringent cGMP, cGLP or cGCP requirements.