AESKU.DIAGNOSTICS is a leading manufacturer of in-vitro diagnostic tests for diagnosis and screening of autoimmune diseases. We stand out due to having the internal capabilities to manage all steps in assay development. Our expertise ranges from identifying new markers and performing feasibility studies over assay development and clinical validation to manufacturing and sales.
Therefore, we bear full responsibility for our products to be of high quality, reliable, stable, excellent in performance, available in time, and traceable.
Research and Development
AESKU.DIAGNOSTICS R&D inhouse departments main focus is to develop new, innovative products based on our customers needs and market requirements. Since its foundation, AESKU.DIAGNOSTICS specifically invests in research and development projects. Highly qualified scientists cooperate with application specialists to develop autoimmune diagnostics for:
- Identification of diseases and disease potential
- Differential diagnosis
- Therapeutic drug monitoring
Research cooperations with renowned research institutions, e.g. the Universities of Hannover, Munich and Tel Aviv or the Johns Hopkins University in Baltimore, USA, and with renowned companies strongly support the company’s competence in in-house product development.
TEAM
Our young R&D team is build by professionals from molecular biology, protein chemistry, and cellculture, with extensive experience in scientific questions and project management.
Besides our key challenge to develop innovative products, many other activities are part of the R&D work:
- Improvement and extension of our product portfolio
- Supporting quality assurance via documentation
- Processing customer wishes
- Supporting clinical studies
- Scientific support of marketing and sales
- Providing trainings, workshops and conferences
- Coauthors of AESKU.Science
- Supervision of diploma thesis
ANTIGEN PRODUCTION
AESKU ELISA tests are coated with antigens that bind disease-specific autoantibodies. Depending on the antigenic epitopes, recombinant or native antigens are used in the tests to achieve a high clinical specificity and sensitivity.
AESKU.DIAGNOSTICS has the skill, experience and capabilities to produce and select the most suitable antigens for the specific assay among recombinant or native sources.
Most of our antigens are recombinant which has the following advantages:
- No variability in antigen quality
- Availability in high quantity
- Selection of the appropriate host for highest specific and sensitive antigen
The three divisions molecular biology, cell culture and protein chemistry work hand in hand in our state-of-the-art laboratories to in-house produce our recombinant antigens.
In a first step, the mRNA of the antigen will be isolated from natural tissue and reverse transcribed into cDNA. After amplification by PCR the cDNA will be cloned into a vector and transformed into different hosts.
A variety of cloning systems have been established (Mammalian, Baculovirus, E.coli, and yeast) with the objective of getting the optimal combination of cloning and expression system for each antigen. If the most suitable expression system is found, the next steps will be to up scale the antigen production and to purify it by column chromatography. To find the best purification strategy a variety of matrices will be tested and the results will be analyzed by gel electrophoresis and blotting techniques. In addition, the sensitivity and specificity of the antigen will be confirmed by ELISA to guarantee reliable and reproducible antigen quality. Prior to its use the antigen will be stored by cryoconservation.
The overall development is recorded by documentation in alignment with regulatory requirements.
Reagent Production
AESKU.DIAGNOSTICS' manufacturing facilities and equipment are state-of-the-art and meet international GMP requirements. Highly skilled production personal ensure the reliable production of our comprehensive product portfolio and the traceability of every single kit.
We have a production capacity of up to 500 plates per hour and the plates are coated with a special procedure under a controlled environment.
All work is performed with qualified instruments with an automatic filling system for accurate volumes and an automatic labelling system. Our four cold rooms provide a big storage capacity of 250 square meters.
AESKU.DIAGNOSTICS can guarantee a high reagent and plate stability with up to 24 months expiry date.
Regulatory
Highly qualified lab technicians assure the good performance of our tests. Two quality controls are performed during the production process of the kit: these are the in process QC after the coating of the micro titer plate and the final QC with clinical studied samples. Kits are always calibrated against international standards or, if not available, against clinical well defined samples.
QC includes both manual and automatic methods using the most popular automated systems. Kit troubleshooting is performed with the aid of several different methods (ELISA, IFA, RIA, ect). Additionally, AESKU.DIAGNOSTICS offers its customers a second opinion lab service to support the end-users with problematic samples.
For an independent control of our tests AESKU.QC department participates in several external QC programs (UKNEQAS, RCPA, CAP, INSTAND).
QUALITY MANAGEMENT
AESKU.DIAGNOSTICS already established a QM system many years ago to meet strictest quality criteria to our work. All work is performed in accordance with GMP and GLP.
Our QA system is determined in more than 90 standard operating procedures (SOPs) and its compliance is regularly controlled by internal inspections from our QA department.
Yearly certification audits enable us to proof and continuously enhance our QM system according to the current requirements of the FDA, Canadian Medical Device Regulations and the European IVD regulation.
The high quality standards are maintained using a controlled documentation to ensure the traceability of our products and regular training of our employees.
Milestones of our QM system:
- Complete range of our products is CE marked
- 510K clearance for 33 products
- Certification EN ISO 13485:2016
Sales and Marketing
AESKU.DIAGNOSTICS offers its customers efficient order processing, on-time delivery and impeccable customer service to meet their expectations.
Our product managers support our customers in all product and scientific queries and refer customer wishes to the related departments. Moreover, AESKU.DIAGNOSTICS offers its customers frequent workshops to gain insight into our company and its products.
Our technical service handles customer questions by phone or via e-mail and assists them onsite to get accurate and reproducible results with our kits and the instrumentation (Triturus, AESKU.SEVEN-UP and HELMED®).
AESKU.DIAGNOSTICS sales force is a team of highly-skilled employees with a scientific background that are spread all over Germany to provide our customers a contact person on site. Our sales force is trained regularly by our marketing and R&D department in order to give our customers the best possible support.
AESKU´s innovative ELISA and IFA tests for the diagnosis of autoimmune diseases are now available worldwide in more than 80 countries through competent partners.
Twice a year our distributors are invited to participate on our product trainings to keep them informed with our products and marketing concepts.
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