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.