Specifications
| Parameter | Specifications |
| Appearance | Clear, colorless solution |
| Identity (SDS-PAGE) | MW approx. 95 kDa |
| Volume activity | ≥ 5 U/µl |
| Purity (SDS-PAGE) | > 98 % |
| Performance test: PCR on DNA | 0.5 kb fragment positive down to 5 pg |
| Performance test: PCR on genomic DNA | 0.1 kb fragment positive down to 5 pg |
| Ribonucleases (up to 10 U, 1 h, 37 °C) | Not detectable |
| Endoonucleases (up to 10 U, 16 h, 65 °C) | Not detectable |
| Exonucleases (up to 10 U, 16 h, 65 °C) | Not detectable |
| Nicking activity (up to 10 U, 16 h, 65 °C) | Not detectable |
| E. coli residual DNA | < 1 fg / Taq Unit |
| Bioburden | ≤10 CFU/ml |
| Stability | 24 months (at -20 °C) from date of manufacture |
| Animal-derived additives | None |
Additional info
Package content  | Diamond Taq™ (5 U/μl)
From 1,000 units to customized volumes |
| IVD-GMP reaction buffer (10x)
750 mM Tris-HCl pH 8.8 (at 25 °C), 200 mM (NH4)2SO4, 0.1 % (v/v) Tween 20, stabilizer |
| IVD-GMP MgCl2 solution
25 mM MgCl2 |
Shipping & storage conditions
| Shipping on dry ice |
| Storage at -20 °C is recommended |
Storage & dilution buffer
20 mM Tris-HCl, 1 mM DTT, 0.1 mM EDTA, 0.1 M KCl, 0.5 % Nonidet P40 (v/v), 0.5 % Tween 20 (v/v), 50 % glycerol (v/v), pH 8.0 (4 °C), stabilizer
QC Results
Performance test Diamond Taq™ is a highly sensitive polymerase that efficiently amplifies DNA even at very low concentration. The higher yield of amplification products allows increasing the performance of the assays.
Residual Escherichia coli DNA Content The entire process (production, purification and fill & finish) is performed under controlled conditions in GMP-Pharma facility leading to the release of a product with a low bioburden.
Moreover, the highly optimized purification processes used permit to obtain an extremely low level of residual content (including host) that allows amplification of wider range of target, including Escherichia coli.
Reproducibility batch-to-batch
| Diamond Taq™ | fg of DNA / Taq Unit |
| Batch A | 0.94 |
| Batch B | 0.20 |
| Batch C | 0.46 |
| Batch D | 0.09 |
| Batch E | 0.01 |
Residual E.coli DNA content: DNA from E. coli was quantified in several batches of GMP Taq DNA Polymerases (at 5 U/µl).
Comparison with competitor
| | fg of DNA / Taq Unit | E.coli Genome copies / Taq Unit |
| Diamond Taq™ (Batch E)* | 0.01 | 0.002 |
| Competitor GMP Taq | 5800 | 1160 |
*Batch currently sold
Not detectable Escherichia coli DNA was observed after Polymerase Chain Reaction on bacterial 16S RNA and genomic DNA.
Features & Benefits
| Utilizing numerous redundant process control checklists to eliminate possible errors at all stages of manufacture |
| Incorporating stringent SOPs and change control procedures to ensure rigorous lot-to-lot consistency |
| Providing comprehensive and detailed batch record documentation substantiating strict adherence to our partners’ required quality specifications |
Every aspect of the manufacturing process is monitored and documented providing our partners a level of confidence in quality and regulatory compliance virtually unparalleled in the industry.
Eurogentec has a customer-proven track record of success in delivering our partner’s mission critical, GMP-assay components on time, every time-guaranteed!
| Features | Benefits |
| Fully GMP compliant process | Exceptional quality, consistent lot-to-lot reproducibility, full traceability. |
| ISO 13485:2003 standard & FDA 21 CFR part 820 QSR compliance | Approved for use of in in vitro Diagnostic assays, Lab Developed Tests and with ASRs |
| Extremely low bioburden through production in GMP-Pharma facility and highly optimized purification process | Very low levels of fungal and bacterial DNA (including residual E. coli DNA) allow amplification of wider range of targets |
| Guaranteed single production batch for a minimum of 1 year | Reproducible performance is assured |
| Flexible solution for fill & finish | Cost-effective tailored solutions |
| GMP reaction buffer & MgCl2 provided | Complete package |
| Highly sensitive DNA Polymerase | Higher yield of amplification products gives increased performance of your diagnostic assay |
| Similar enzyme as extensively validated EGT GoldStar® | Proven performance in many application |
Quality System
Our Quality Management System is fully compliant with the ISO13485:2003 quality standard and FDA’s QSR (21 CFR 820). Our GMP facilities incorporate a secure card-key system for access and permit full segregation of production, purification and fill & finish processes.
The entire process is performed under controlled conditions; in class 10,000 clean room for purification (ISO 7 with < 100 cfu/m³) and in class 100 laminar flow hoods for fill & finish (5 in with < 1 cfu/m³). Final product is released by our Quality Assurance Department with a formal Certificate of Analysis. Full batch records are maintained and can be reviewed during customer or regulatory audits.
Highly Controlled Upstream Process Control
Each supplier is carefully screened and approved.
All reagents undergo rigorous Quality testing to guarantee exceptional quality and reproducibility of the finished product.
Quality Systems
We have built a strong and comprehensive cGMP Quality System over the past 15+ years:
| cGMP manufacturing authorization since 1993 for our recombinant protein and vaccine production. Over 70 products prepared for phase I and phase II clinical trials |
| Current 9001:2000 certification |
| Quality Management System compliant with 13485:2003 and 21CFR Part 820 standards |
| Rapidly growing portfolio of diagnostic and service laboratory partners in Europe and North America |
Quality System Management
| High level of education and training |
| Strict process segregation and employee gowning policy |
| Supplier qualification and evaluation |
| Comprehensive batch records with full traceability |
| IQ/OQ/PQ maintenance and calibration standards |
| Dedicated equipment |
| Stringent document change control procedures |
| Deviation management |
| Process control |
| Exhaustive analytical method validation |
| Critical analysis & documentation rationale |
| Independent |
| QC department for assuring exact specifications prior to release |
| Routine internal audits |
| Customer quality audits |
| Sample retention to facilitate troubleshooting |
| Quality Agreements and/or Supply as extension of the manufacturing contracts to clearly define our responsibilities to our partners |
Quality Control Release Methods
| Identity |
| Physical inspection of product |
| Volume activity |
| Specific activity |
| Purity |
| Performance tests (on λ and genomic DNA) |
| Absence of Ribonuclease, Exonuclease and Endonuclease |
| Absence of Nicking activity |
| Residual content |
| Bioburden |
Certificate of Analysis
Our products are provided with a certificate of analysis, a document detailing the release based on the batch record and signed by the QC authorized person.
Customer Care
 | First and foremost, the Eurogentec diagnostic team believes that knowing its customer needs and expectations is essential to the success of any collaboration. Long-term relationships with our customers are built on trust and mutual respect. In dealing with you as customer we operate from following values: |
Quality
We provide the highest quality services and continuously work on maintaining and further improving our quality level.
Respect
We respect you as a customer and operate from the principle that we are partners. We are honest, open and flexible.
Innovation
We expand our services continuously with advanced and innovative technologies.
Service
We are in service to your business and provide timely and adequate answers to all of your questions. We are proactive and responsible in our approach.
A dedicated Key Account Follower acts as your “eyes and ears” in the production plant. Your assigned “EUROGENTEC in-house advocate” monitors the complete production process and is able to provide you with frequent real-time updates during each production run.
Professional support for manufacturers of diagnostic assays
| All projects are handled with complete confidentiality. A confidential disclosure agreement (CDA) is standard and is executed during the initial stages of communication. |
| Project-specific details (synthesis scales, chemistry, QC specifications, sequences, regulatory requirements, time frame, patent situation, etc.) are discussed and documented. |
| Quality Agreements and/or Supply Agreements are extensions of the manufacturing contract clearly defining EUROGENTEC’s and or partner’s respective obligations. |
| Upon request, a pilot run program may be initiated prior to making a final offer. |
| EUROGENTEC is registered in the USA as an ASR manufacturer with the FDA under Medical Device Manufacturer registration number 3003830126. |