- Custom assay development
- Bulk supply of catalogue and custom reagents
- Custom packaging
- Private label OEM manufacture
- Validation support
- Scheduled deliveries
- Fast track technical support
Custom Assay Development Capabilities
The Custom Solutions division of Bioline offers custom assay development services, conducted by our highly-experienced, London-based R&D team. This team has been developing custom assays for over 10 years and has established a reputation for formulating assays that perform reliably in even the most challenging conditions. Collectively our R&D team have over 50 man-years of custom assay development expertise and have an unparalleled understanding of enzymology and buffer chemistry and how they influence assay performance.
Our development experts are adept at making adjustments to reagent formulations to achieve the highest performance levels in terms of assay sensitivity, reproducibility, accuracy, inhibitor tolerance and specificity. We understand that achieving target performance levels can be about optimizing magnesium concentration, reaction volume, dNTP concentration, pH, dUTP concentration and/or thermal cycling parameters. In the pursuit of reliable assays we routinely verify thermal stability, assay repeatability and freeze-thaw stability.
Our industrial partners belong to many sectors, including agricultural biotechnology, pharmaceuticals, in vitro diagnostics, contract research, veterinary diagnostics, and the assays we’ve developed for them span many applications. The tests we’ve developed are being routinely applied to crop research, food testing, animal health, biomarker discovery, pathogen detection and drug discovery.
Our complete portfolio of reagents, which can be customized to meet your individual assay performance specifications, encompasses qPCR, reverse transcription, RT-qPCR and end-point PCR. These include;
- SensiFAST qPCR Mix
- SensiFAST One-Step RT-qPCR Mix
- MyTaq PCR Mix
- MyTaq One-Step RT-PCR Mix
- Glycerol-free, lyo-ready SensiFAST qPCR Mix
- Glycerol-free Taq DNA polymerase
- High-concentration Taq DNA polymerase
- Reverse transcriptase
- JetSeq NGS library preparation
If you have alternative requirements, our assay development capabilities mean we are in a strong position to assist. We maintain a full development pipeline of new products, meaning our portfolio of custom reagents is rapidly evolving. The next additions to our custom portfolio will include our lyo-ready one-step RT-qPCR Mix, glycerol-free reverse transcriptase and high-concentration hot-start Taq DNA polymerase. However, we are willing to consider undertaking any development project. Click here if you would like to discuss your individual requirements with our custom assay development experts.
Custom Assay Development Process
Our R&D team follows a stage-gate process when developing custom assays for our industrial partners. This is to drive process efficiency and to maintain our quality standards, but more importantly to ensure we achieve target performance specifications within the desired timeframe. Furthermore, the process prompts communication between Bioline and its partners at each key stage of the project to ensure perfect alignment and understanding with respect to project progress. From early stage development through manufacturing and delivery, our process is tightly controlled to ensure consistency. We offer consultation and technical support to help make design decisions, scientific expertise that matches your requirements and customized confidentiality agreements.
Modifying assay format can bring advantages in terms of delivery, storage, cost and even performance. Bioline has considerable experience of lyophilizing reagents to convert aqueous phase assays in to lyophilized, or lyo-ready analogues, that both meet the highest standards of performance and improve accessibility to end-users. The advantages of lyophilisation include;
- Maximization of reagent quality and performance
- Simplification of workflow
- Provision of room temperature stability
- Enabling incompatible reagents to co-exist
- Reducing manufacturing and delivery costs
- Streamlining product time to market
- Increasing storage capacity without increasing overheads
Bioline, together with our collaborators, including BIOLYPH, are able to lyophilize almost any reagents whilst achieving target assay reproducibility, sensitivity and specificity. Click here to learn more about our assay format options.
Design of Experiments Methodology
In the pursuit of optimal assay performance, our Bioline Custom Solutions division follows two alternative, but often complementary development paths, namely our fast and standard development tracks. Typically, if a development project is considered multi-variant (e.g. one-step RT-qPCR), our R&D team follows our fast-development track, which applies leading-edge Design of Experiments (DoE) methodology. DoE is defined as systematic method to determine the relationship between factors affecting a process and the output of that process. Our fast track process applies DoE methodology to predict the best combination of multiple assay variables. Our standard track process is applied either when a development project is considered single variant (e.g. normalization of gene expression analysis), or when verifying the performance of an assay formulation predicted by our fast track process.
Bulk Reagent Supply
Bioline can supply catalogue and custom reagents in bulk quantities. Our production facility is highly flexible, meaning we are able to respond very quickly and can manufacture reagents in a very broad range of batch sizes, to meet your individual throughput requirements. Custom packaging is also available for when your individual reagent volume requirements necessitate novel product assembly. Click here to request more information regarding our bulk supply options.
We manufacture over 300 off-the-shelf and custom reagents in our German production facility, which is located near Berlin. Our Production team includes over 30 dedicated manufacturing scientists and technicians, as well as 8 dedicated QC scientists. Our German facility employs state of the art equipment and is capable of small-scale to multi-litre volumes of reagent production. The capacity and flexibility of our production facility enables us to respond quickly to any throughput requirements.
Bioline understands the importance of adhering to the ISO 13485 quality standards when developing and supplying custom reagents. Hence, all custom work is performed in accordance with ISO 13485.Our ISO certification confers the following benefits to our stakeholders:
- Complete confidence in Bioline
- Reassurance of risk definition & management
- Supply chain security
- Materials traceability
- Manufacturing consistency
- Reproducible high standard of quality
Our adherence to the ISO quality standards not only confirms our commitment to being a reliable and technically competent partner, it also means we have greater understanding of our customers’ and partners’ requirements and are committed to further developing our industrial partnerships.
Bioline guarantees absolute confidentiality. If it is your preference, we can draft a Non-Disclosure Agreement (NDA) for co-signing before discussing your technical requirements.
Click here if you would like to know more about our custom solutions.