Our quality system
Quality, confidentiality, and compliance are at the heart of what we do. We maintain the highest standards to ensure both the precision and accuracy of sample results and allow you to retain ownership of these results.
We know that our clients expect the highest standards. To deliver this we have implemented and keep a quality system up to date using relevant ICH Q6B guidelines, standards, and pharmacopeial chapters, where compliant with GMP. We have standard operating procedures (SOPs) in place for all GMP processes and run regular audits to ensure the highest levels of compliance. Data are stored securely for a minimum of 5 years.
Certification - GMP
Alphalyse received a GMP certificate from the Danish Health Authorities to perform quality control of active pharmaceutical ingredients.
This means we can set up validated mass spectrometry assays for analyzing process-related impurities e.g., Host Cell Proteins (HCPs) under GMP conditions according to EMA regulations.
Our team worked for more than eight years to develop a robust assay and solve the complex challenges related to MS analysis of host cell proteins.
The GMP certification (147346 and 147347) concludes a three-year investigation of our mass spectrometry-based Host Cell Protein analysis (HCP-MS) method’s robustness and reproducibility across more than 400 projects.
We use the same set of 7 standard proteins as internal standards for all residual protein projects, both for normalization and for quality control. This allows us to evaluate different parameters of importance for method validation and for transferring the method to a GMP environment.
We have successfully worked with clients to provide results under GMP conditions. Here are a few examples:
Bavarian Nordic A/S significantly shorten the time necessary to document HCP impurities in COVID-19 vaccine candidate for Phase 3 clinical trial using MS-based HCP analysis under GMP conditions.
Actinobac Biomed Inc received FDA approval for an Investigational New Drug Application (IND) using only mass spectrometry data to monitor host cell proteins in an unusual cell line.
Any questions? Fill out the contact form to learn more about our quality system and standards.
Certification - GMP
Alphalyse received a GMP certificate from the Danish Health Authorities to perform quality control of active pharmaceutical ingredients.
This means we can set up validated mass spectrometry assays for analyzing process-related impurities e.g., Host Cell Proteins (HCPs) under GMP conditions according to EMA regulations.
Our team worked for more than eight years to develop a robust assay and solve the complex challenges related to MS analysis of host cell proteins.
The GMP certification (147346 and 147347) concludes a three-year investigation of our mass spectrometry-based Host Cell Protein analysis (HCP-MS) method’s robustness and reproducibility across more than 300 projects.
We use the same set of 7 standard proteins as internal standards for all residual protein projects, both for normalization and for quality control. This allows us to evaluate different parameters of importance for method validation and for transferring the method to a GMP environment.
We have successfully worked with clients to provide results under GMP conditions. Here are a few examples:
Bavarian Nordic A/S significantly shorten the time necessary to document HCP impurities in COVID-19 vaccine candidate for Phase 3 clinical trial using MS-based HCP analysis under GMP conditions.
Any questions? Fill out the contact form to learn more about our quality system and standards.
Confidentiality agreements
You have three options concerning confidentiality agreements (CDAs):
- Service without any confidentiality agreement
- Signing or modifying our standard CDA
- Your own CDA, Non-disclosure agreement (NDA) and/or Master Service Agreement (MSA)
You do not need to sign a confidentiality agreement or master service agreement to use our service. But we know that many organizations need to set it up before starting to collaborate. To make the process swift and easy, we have prepared a standard CDA.
Our standard CDA considers the interests of both you as a client and us as the supplier. Our only interest is to provide you with a service to help you move forward with your project. The way we perform the service is based on our core knowledge, and the samples and the data generated from them are your property.
Please get in touch with us if you would like more information about CDAs or MSAs.
Are you using Scientist.com?
If your organization utilizes the Scientist.com procurement platform, you can use this solution to contact us. Then we will automatically use the CDA that is in place on this platform and agreed with your legal department.
Talk to us
Whatever protein-related challenge or question you may have, we would love to help. Our experts can help you decide on the best analytical approach for your project by email or online meeting - providing advice without obligation.