Comprehensive Analytical Services To Support Development Programs

Assay Development Specialization

Our Assay Development team specializes in protein assays, virus assays, residual impurity assays, DNA assays, as well as potency and product characterization and detection of endotoxins.

Our analytical services cover early process development through scale-up to commercial manufacture, ensuring end-to-end consistency and comparability of data throughout the lifecycle of a product. These include method development, method transfer, implementation and validation, raw material testing and release, in-process testing (viral, bacterial, protein and DNA), release testing, stability testing, as well as cleaning and validation analytics.

ANALYTICAL SERVICES

• Method Development
• Method Transfer
• Method Verification
• Method Qualification
• Method Implementation & Validation
• Raw Material Testing & Release
• In-Process Testing (Viral, Bacterial, Protein & DNA)
• Release Testing
• Stability Testing
• Accelerated Stability
• In-Use Testing
• Environmental Monitoring
• Utility Monitoring
• Cleaning & Validation Analytics

FAST-TRACK ANALYTICAL METHODS

Next Generation Sequencing (NGS)

NGS allows sequencing of millions of nucleotide fragments (“massively parallel sequencing”). IDT Biologika uses this technology for a broad range of different applications, such as characterization of different strains, identification, purity of populations and strain stability after virus replication. All sequencing assays are completed by our bioinformatics services.

Adventitious Agents Testing (AVT)

Based on Next Generation Sequencing (NGS) technology, IDT Biologika uses its own developed bioinformatics analysis pipeline to conduct Adventitious Agents Testing (AVT). NGS is much faster than conventional animal testing, classical qPCR-approach, and in-vitro tests.

hcDNA/Fragmentation

For the detection of DNA impurities from the species Gallus Gallus (e.g. by using DF-1 manufacturing cell lines), IDT Biologika developed the chicken residual host cell DNA (hcDNA) assay. It is a quantitative PCR (qPCR)-based assay with high sensitivity and specificity. The results are generated within a few hours by a streamlined workflow consisting of DNA extraction and subsequent qPCR analysis.

Mycoplasma Testing by qPCR

IDT Biologika developed and validated a qPCR assay for fast determination of a broad range of mycoplasma, including non-cultivable mycoplasma and those which cannot be detected with the classical indicator method. With this assay, a significant reduction in the testing timeline is achieved.

Mycobacteria qPCR

IDT Biologika offers a fast mycobacteria test using qPCR. It provides results after just three days, whereas the classical microbiological method takes about of eight weeks. With this new test method, a broad range of mycobacteria species are detectable within a sample volume of 10 ml.

Genomtiter/ddPCR

Digital droplet PCR ddPCR is a highly sensitive technology for the quantification of DNA/RNA, without the need for a DNA/RNA standard. Therefore, the development of such an assay is faster than using a classical qPCR.

At IDT, ddPCR is used for a broad range of different analytics. This includes quantification of virus material, examination and quantification of viral/bacterial contaminations, and characterisation of control material. In addition, ddPCR is used for most of the genome titer determination assays.

Fluorescence-based Flow Cytometry

For cell based potency determination and characterization of viral vaccines, IDT Biologika offers fluorescence-based flow cytometry as a more rapid and more objective analysis than conventional plaque forming cells and dilution techniques.

Protein Profiling based on Capillary Electrophoresis

For fingerprint analytics of protein profiles in viral vaccines on different process steps, IDT Biologika offers Capillary Electrophoresis analytics (SDS-PAGE mode). Here, the specific protein profile of different process steps can be visualized for characterization of the downstream process, and also specific protein identification and quantitation is possible.

Highly Specific Protein Identification and Quantitation via Mass Spectrometry

To identify and quantify proteins in a highly specific manner, for process characterization or as impurity analysis, IDT Biologika offers high-resolution mass spectrometry (Q-TOF) and Triple-Quad-LC-MS/MS. It may be utilized for viral protein expression studies on viral vaccines or as highly-sensitive impurity quantitation for known peptide or protein impurities.

Endotoxin Testing

For endotoxin testing, all classical methods are used – kinetic turbidimetric and kinetic chromogenic, as well as gel clot method. For rapid endotoxin testing of IPCs, the cartridge method using the Endosafe^® nexgen-PTS is available. Endotoxin testing is performed on IPC and EPC samples. Furthermore, incoming goods including primary packaging material (stoppers and vials) are tested for endotoxins. Low endotoxin recovery studies may be performed if required.