Chain of production

Raw materials

To be able to obtain supreme quality we use only the finest raw materials.

Synthesis

We have developed proprietary synthesis methods, where the chemical exposure of the growing oligonucleotide is perfectly balanced. Our synthesis approach gives a high yield and purity after the first production step and also enables us to synthesize long and complex molecules.

Purification

We have also developed proprietary methods for purification. These methods enable us to refine the crude products from synthesis, to extremely pure products. We can purify long oligonucleotides (up to 150 nucleotides) which makes it possible for our customers to use oligonucleotides as template instead of plasmid DNA.

Quality Control

Our competent QC laboratory and their state-of-the-art-equipment, analyses each and every product that is to be used for diagnostic purposes, using methods developed and validated at SGS DNA. This analysis is performed on several separate occasions during the manufacture procedure. Each analysis is then evaluated, and has to be approved in order for the product to proceed to the next production step. Worth mentioning is that we perform extensive fraction analyses for each purification and only proceed with the fractions that meet the specification for purity with regards to the final product. We use HPLC, UPLC, Maldi-TOF and ESI-TOF for our analyses. For more information see under Quality Control.

Contamination Control

We have an extremely careful approach when it comes to prevent cross-contamination. By handling each IVD/ASR product separately under laminair-flow in every step and never expose these products to an uncontrolled environment, we can guarantee non-contaminated products. This approach is obviously time consuming but is of utmost importance in order to secure the correct performance of our products in diagnostic assays. Consequently, line-clearance is needed for each production step and therefore involves extensive cleaning.

Cleaning

In order to be able to guarantee the quality of every single product we do as much in-house as possible, even details normally outsourced, cleaning for example. We have our own dedicated cleaning personnel that follow extensive cleaning procedures. We use cleaning procedures specially designed for contamination control of the production facility and each clean room is cleaned in a separate process.

Traceability

We guarantee full traceability of each product. For each product we document each manufacturing step including information about current specifications, materials and methods used, and results obtained. This type of documentation is filed at SGS DNA and saved for ten (10) years.

Release

Each product manufactured are reviewed and released by the Quality Assurance department prior to shipment to customer.