Roche produces high-quality primers and probes in large quantity. State-of-the-art oligonucleotide synthesis facilities meet the high regulatory requirements for diagnostic applications, adhering to QSReg guidelines. Manufacturing is possible at the μmol to mmol synthesis scale. Oligonucleotide design and production are focused on your specifications and test synthesis is performed upon request.

The risk of cross-contamination is negligible because products are segregated in different purification suites. Rigorous, validated analytical procedures are employed to produce the final product. Roche has developed and manufactures unusual phosphoramidites and modified controlled pore glass (CPG) supports. This labeling technology makes it possible to attach multiple labels in a cost efficient manner.

Custom manufacturing of master mixes meets the requirements of your high-throughput applications. Custom Biotech’s AptaTaq DNA Master for fast PCR includes reagents for PCR optimization.

The AptaTaq DNA Master Optimization Kit allows you to adapt the master to your specific task. Once the composition of the optimal master is fixed, Roche custom manufactures according to the adjusted recipe.

Biosubstances for Regulated Applications

Tailor-made biosubstances are manufactured in large-scale quantities for food- grade applications. Production facilities meet cGMP manufacturing requirements.

Customized Development of GMP-Grade Biosubstances

Roche has vast expertise in cloning, synthesis, process development, upscaling, and production of regulated intermediates and ingredients. Finished products are delivered using supply agreements.

Proven production processes guarantee:

• Very high quality
• High lot-to-lot consistency

Large-scale production enables:

• Large lot sizes
• Short-term availability
• Customized filling, labeling, and packaging 

Roche proven recombinant and native enzymes are available in our contract manufacturing services. Applications range from enzymes as processing aids in the manufacture of pharmaceuticals (biocatalysts, downstream proteases) to molecular biology polymerases and reverse transkriptases. Manufacturing scales range from 10 liter to 50 cbm fermentation volume, or milligrams to hundreds of kilograms of protein.

Our service portfolio for raw materials includes:

• Custom filling and labeling
• Custom packaging
• Lot reservation
• Certificate of analysis with each shipment
• Change Control Notification 

Coating plates for immunological assays:
Roche pioneered immunological assays using state-of-the-art streptavidin-coated plates. Contact us for custom manufacturing of streptavidin-coated plates.

Prefilled microwell plates for PCR:
With the introduction of the Real Time Ready Panels, Roche established the capabilities to manufacture microplates prefilled with detection mixes (primers and probe). Screen the same panel of targets in high throughput using complete panels prefilled with oligos and even DNA master - just add sample and buffer. Plates with dried DNA master mix are available upon request.

Custom Biotech provides you access to one of the broadest liquid-stable clinical chemistry test and homogeneous immunoassay portfolios worldwide. Most reagents can be supplied in a package with generic and analyte-specific controls and calibrators. An enormous amount of scientific backup information, application know-how and support is available to you during your reagent feasibility study and validation.
We provide a secure and stable supply of high quality reagents since Roche manufactures most raw materials required for its own reagent production in-house.

Selecting an OEM manufacturer requires evaluating many aspects of the respective organization's capability technology. Custom Biotech has a proven track record in manufacturing both individual assay components and complete ready-to-use kits in the quantities you require. Kit formulation, packaging, and labeling are performed, according to your specifications. With us as your OEM partner, you spend more time turning ideas into reality.

Contact your regional Custom Biotech team.