Lyophilization service

 

LYOPHILIZATION SERVICE
A customized service with a great economical value.

Sentinel Diagnostics provides full lyo custom services, from the lyophilization of liquid reagents provided by the customer,
up to a broad portfolio of solutions to help our customers accelerate the launch of their products.

 

 

 

INTERESTED?
We want to give you all the information you need. Do you have some questions? Maybe the answer is already below.

Does Sentinel have experience in lyophilization of PCR master mixes?

<strong>Does Sentinel have experience in lyophilization of PCR master mixes?</strong><br>

Yes, we have internally developed a patented technology (STAT-NAT®) for ready-to-use PCR master mixes and we have generated long-term stability data on lyophilized formulations up to 55°C. Our expertise is not limited to the lyophilization of liquid reagents provided by the customer, but includes: reagent optimization, V&V, manufacturing, manufacturing of final kits, quality control and regulatory registrations.

Do you provide lyophilization service under a certified quality system?

<strong>Do you provide lyophilization  service under a certified quality system?</strong><br>

Sure! Sentinel operates under a state of the art Quality System, since we have been certified ISO 9001 and ISO 13485 standards. Our objective is to meet customer needs, thus we can perform any testing of the lyophilized product. We also include a Certificate of Analysis or some other product quality documentations with the shipment and we provide a cGMP manufactured lyo mix.

What are the formats in which Sentinel can lyophilize a PCR master mix in?

<strong>What are the formats in which  Sentinel can lyophilize a PCR  master mix in?</strong><br>

We have vast experience in manufacturing reagents in standard and proprietary plastics used by both our partners and clients. The most common are 8-well strip PCR tubes and 96-well PCR plates (no limitation on type or brand).

Is it possible to perform pilot-lots?

<strong>Is it possible to perform pilot-lots?</strong><br>

Of course. We can perform pilot-lot lyophilization from 5 up to 72 x 96-wells plates. If you are interested in 8-wells strip vials, pilot-lot lyo vary from 5 up to 72 frames of 12 x 8-wells strips.

Can I give you my PCR master mix in liquid formulation, as it is?

<strong>Can I give you my PCR master  mix in liquid formulation,  as it is?</strong><br>

Yes, but only if it is lyo-ready, that means without lyo interferences, e.g. glycerol. If not, the master mix has to be optimized and enters in a R&D process where information of the formulation needs to be shared.

What is the price of the lyophilization service?

<strong>What is the price of the  lyophilization service?</strong><br>

Our service has a great economical value and can be customized based on customers’ needs (lyo only, QC, kitting, consultancy support).

REQUEST A QUOTE

 

MORE QUESTIONS?
Don’t hesitate to contact us
and request further information.