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The Octet^® R8 label-free protein analysis system provides fast, high throughput, and accurate characterization of biomolecules and is compatible with longer experimental run times and seamless integration into GxP-compliant labs during biologics development.

The 8-channel Octet^® R8 system performs quantitation and kinetic analysis of up to 96 samples in 30 minutes to 2.5 hours, depending on the specific assay. An optional microplate evaporation cover minimizes losses in sample volume, allowing post-analysis sample recovery even after an experiment.

The system can be used for a wide range of analyses including kinetic analysis, titer of IgG and other proteins, reagent qualification, immunoassay development, bioprocess development, quality analysis, crude antibody screening, epitope binning/mapping, ligand binding assays, small molecule analysis, elucidating cell signaling mechanisms, and infectious disease monitoring. Analysis can be done using a single channel or up to eight channels, enabling flexibility in sample throughput.

Rapid Quantitation of AAV Capsids for Various Serotypes for Bioprocess Development and Quality Control in Gene Therapy.

• Rapid, direct, and label-free quantitation of AAV capsids in crude and purified samples
• Specificity to various AAV serotypes, including AAV1 – AAV9 and AAVrh10
• Direct quantitation of AAV capsids in the  dynamic range of 8.5E8 – 1.0E13 vp/mL
• Efficient and cost-effective regeneration for biosensor reuse up to 10 - 20 times
• Good correlation of the results with ELISA

AAV vector development and production at industrial scale requires an efficient method for accurate quantitation of viral capsids in both upstream and downstream bioprocessing. Octet^® Bio-Layer Interferometry (BLI) systems in combination with the Octet^® AAVX Biosensors offer a rapid, label-free, and high-throughput method for quantification of AAV capsids at various stages in bioprocessing.

Octet^® AAVX Biosensors are pre-immobilize with Thermo Scientific^TM CaptureSelect^TM Biotin Anti-AAVX Conjugate, from Thermo Fisher Scientific Inc, that binds with high affinity and specificity to various native and recombinant AAV serotypes, including AAV1 to AAV9 and AAVrh10. Due to its high specificity the AAVX biosensor can be used to quantitate AAV capsids in both purified and crude cell culture samples with titer in the range of 8.5E8 – 1.0E13 vp/mL for most serotypes.

AAV titer can be measured on the Octet^® platform in as little as 15 minutes, providing an efficient alternative to time-consuming and laborious techniques such as ELISA and HPLC. Finally, the Octet^® AAVX Biosensors can be efficiently regenerated up to 20 times, which makes them an extremely useful and cost-effective solution for high-throughput AAV capsid titer measurement in process development and QC.

Growth factors and cytokines in preclinical and GMP quality grade for consistent ex vivo expansion and differentiation of various human cell types.

• Proven high activity levels ensuring cost-efficient production  
• Seamless transition from early development to clinical stage: equal product quality & performance
• Highest safety level: manufactured in dedicated animal-free GMP facility
• Consistent cell expansion and differentiation: exceptional batch-to-batch consistency

Both quality grades are produced under the same conditions, using identical production steps and expression systems. This ensures equal product quality and performance.  

The difference between both quality levels is that we offer more comprehensive quality control (QC) testing including tighter specifications and documentation for our GMP products. Our preclinical grade products, therefore, offer a cost-efficient alternative for the early development phase when regulatory support and quality of raw materials have a lower priority and access to GMP-relevant documentation is not required yet. 

Advantages of a seamless transition:

• Avoid spending time on optimizing your cell therapy manufacturing process when moving to the clinical phase
• No need to spend valuable time and money on clinical comparability studies
• Bring your cell therapy faster to the market

High Quality – High Performance, from Research to ATMP
CellGenix^® serum-free GMP media combine a maximum of quality and safety with excellent performance due to state-of-the-art production, stringent quality control and expert regulatory support. This ensures reliable and consistent results which is crucial for the standardization of your ATMP manufacturing process.

Rely on xeno- and serum-free media with stringent batch-to-batch quality control for safe use in clinical trials and commercial cell therapy manufacturing.

CellGenix^® GMP DC

• Serum- and xeno-free medium
• Optimized formulation for the generation of DCs
• FDA Drug Master File available

CellGenix^® GMP SCGM

• Serum-free and xeno-free medium
• Reliable and consistent cultivation of HSCs and NK cells
• FDA (USA) and PMDA (Japan) Drug Master File available
• Generation of retroviral and lentiviral vector-producing cells