Get answers to
frequent questions

What analytical services can VelaLabs provide in-house?

(1) Bioassays (cell based and reporter gene assays) and FACS in the Cell-Based Assay group
(2) SPR, ELISA, MSD in the Ligand-Binding Assay group
(3) HPLC, classical gel electrophoresis, compendial methods according to EP and USP in the Physico-Chemical Methods group
(4) (q)PCR, sterility, bacterial endotoxins in the Microbiology group

Check out the pages of our lab groups to find out more information.

What analytical services can VelaLabs provide with its partner network?

(1) In cooperation, we can provide services such as Mass spectrometry, circular dichroism, dynamic light scattering, elemental analysis, capillary gel electrophoresis, capillary isoelectric focusing, atomic absorption spectroscopy, and more of these can be done within the Tentamus Group.
(2) We are further offering Mössbauer spectroscopy, electron paramagnetic resonance, vibrating-sample magnetometry, CHN combustion, (cryo)-TEM, and atomic force microscopy can be done with our trusted partner lab.
(3) We are currently investigating the potential of rapid methods for microbiological testing.
(4) Olink targeted protein biomarker analysis can be done with a trusted partner lab.

Do you offer long-term material storage?

Yes. We can store your samples in the gaseous phase of a liquid nitrogen tank, in deep (-20 °C) or ultra-deep (-80 °C) freezers, cooled (+5 °C), at controlled room temperature, or at a custom temperature and humidity in a climate chamber (up to +50 °C).
Can you transfer methods?
Certainly. We can develop a method and transfer it to a lab of your choice, or we can install a method which has been previously established and/or validated elsewhere. We can evaluate your protocols or reports on a risk-based approach and adapt the method to our equipment and procedures, if necessary. Please contact the Business Development team for details.

Which phases of drug development can be supported?

We can support each and every phase of the drug development process, except for the R&D drug screening /discovery, which would require high throughput screening methods.

 

How does a typical project unfold?

After we receive your analytical request via the homepage form, a phone call, an e-mail, or a meeting at a conference, our business development team gets in touch with you to answer relevant questions such as:
What is the purpose of the request? E.g.: clinical sample testing, scientifically sound testing of product development samples, release testing of a finished product with a validated method, etc.

 

Which analytical methods are required?
Are there any critical deadlines?

A CDA/NDA can be signed at this stage if your process requires it. Once the scope of the project is roughly defined, you receive a non-binding cost estimate to discuss it with your team. You will receive an itemised quotation together with our terms of service after all details have been cleared. Depending on your purchasing process, you can accept the quotation by signing it, either manually or electronically, or by issuing a purchase order referring to the quotation number.

The accepted quote is transferred to a designated project manager who takes care of all the relevant communication. The business development officer completes your client profile together with you by entering relevant information such as VAT number, invoice recipient, etc. The project progress is communicated in a mutually agreed manner, e.g., with scheduled meetings or ad hoc updates based on your current needs. Our work is invoiced based on the milestones defined in the quotation, and the project is considered completed once the last agreed-upon document has been delivered. The project scope can always be adapted during the duration of the project. Additional fees may apply.

What is a method qualification?

Analytical method qualification determines the method’s analytical capabilities after the method setup. The Qualification is sufficient in the early development process of a product (up to clinical Phase II) for which full validation is not required. The method qualification is done on a risk-based approach and includes subsets of validation parameters based on ICH Q2 R1 and other corresponding guidelines, such as accuracy, linearity, specificity, precision, and range. The acceptance criteria of a method are usually set after the method qualification, and therefore, the qualification cannot fail. A change in the method can easily be entered into the Standard operational procedure (SOP) without requiring a re-qualification.

 

What is a method validation?

Validation of the analytical procedure is the documented evidence that the method is suitable for the intended use under normal operating conditions. The Validation is required from clinical Phase III onwards. Analytical method validation is done on a risk-based approach and takes into consideration the life cycle of facilities, equipment, utilities, process, and the product itself. The validation parameters are based on ICH Q2 R1 and other corresponding guidelines, such as: accuracy, linearity, specificity, precision, and range. The acceptance criteria of a method must be set before the validation starts. As such, a validation can fail, and in that case, it would need to be redone. Any change in the method SOP requires a re-validation.

 

What is a method verification?

Methods which are described in a pharmacopeial monograph do not need a full validation and can be verified according to the already established acceptance criteria. VelaLabs routinely handles method verifications according to the EP and USP monographs.

 

VelaLabs has previously validated the method, so why do I need a new validation for my biosimilar?

As our client, you own the methods we have qualified or validated for you. While it is possible to measure your samples with the method we have validated for another client, any change in that method will influence the way we handle your samples as well, potentially rendering them invalid. Therefore, we always recommend customizing the method for your product of interest so that you get the most accurate relevant data.
We do not use data from other clients to set up the validation package for you. We are also not going to use your data to set up validation packages for someone else.
The regulatory agencies almost always require specific method validation for your product.

 

How do material pass-through costs work?

Our business development team provides a material cost package in the quotation. This is an estimation based on the information you have shared, our experience with the methods, and the current market prices. We pass through to you the costs of the material we have ordered for you, along with a 10% surcharge which covers delivery fees, material inspection, GxP logbook maintenance, and proper storage at VelaLabs. In case the material budget is not exhausted, the difference is written off, and you do not pay anything extra. In case we need to order more material than anticipated or the material prices have risen so that we are about to exceed the budget, the project manager gets in touch with you to extend the material package based on the current project requirements.

 

How many projects does VelaLabs handle per month?

We typically handle work packages of about 75 parallel projects for 30 different clients per month.

 

Why do I need to announce samples?

We strive to utilise our resources for maximum productivity for you, according to the plan. If your samples arrive unannounced, we can only measure them whenever there is a gap in the already planned analysis slots. By announcing your samples well in advance, you can ensure that a dedicated laboratory time slot, equipment, material, and an operator are made available for you. Proper prior planning prevents poor performance, and the same applies to both parties - you and us.

We are obliged not to accept samples that are not covered by a valid contract (signed quote or purchase order). If you are not sure whether you have a valid contract, please contact our team before sending the samples.

How do you store samples?

Our clients specify the storage conditions in a sample submission questionnaire before each sample is delivered. All our storage equipment is qualified and monitored 24/7, with a fast-response team standing by in case of malfunction.

Why do you choose the 4PL and not the linear approach for potency evaluation?

The 4PL approach provides more information about how the samples behave in the assay. The top, bottom and IC50 parameters are more accurate and allow a more precise estimation of the sample validity, even if their curves are not completely parallel.

What is the difference in your processes regarding non-GMP and GMP measurements?

All our equipment is GMP-qualified, and we handle all samples according to our GxP guidelines. However, non-GMP sample measurements are described in an analysis report which is released by our QC department. In contrast, GxP samples have a larger quality-related footprint, require additional checks, and the CoA, which summarises the results, is released by our Quality assurance (QA) department.

Since you are offering PK analysis, are you offering PK modelling and PK/TK calculations?

No. Our business authorisation does not include evaluation of clinical trials.

Why should I not use a product release method for clinical analytics and vice versa?

We do not recommend it because of the matrix effects. While the product release methods analyse the sample in the (final) formulation for market release, the clinical analytics typically measure the sample in the context of biological matrices such as plasma, serum, and sometimes even in organ tissues. These can have profound effects on the acceptance criteria and will likely cause a sample to fail if measured with the wrong method. Furthermore, controls and calibrators need to be produced in the same matrix as the samples, so a dedicated validation is required anyway.

Which certificates does VelaLabs have?

GMP and GLP certificates, issued by AGES (the Austrian division of EMA). They are renewed every two years.

 

Is VelaLabs ISO accredited?

Not anymore. In 2020, VelaLabs obtained an ISO/IEC 17025 and 17020 accreditation with the acquisition of LABH (Laboratorium für Betriebshygiene). We decided not to renew the accreditation in 2021.

 

How many audits does VelaLabs have per year?

The VelaLabs QA (quality assurance) team hosts 10-20 audits per year between regulatory agency and customer audits.