Custom Products & Services FAQs

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GENERAL QUESTIONS

General Services webpage

How can Bio-Techne help with my research pain points?

Bio-Techne is not a typical Contract Research Organization (CRO). Through its individual brands, Bio-Techne is a biological reagent development and manufacturing company, that also offers services. In this way we avail all our experience and domain knowledge to our service customers. Our custom-generated reagents are delivered by the same expert scientists who create our catalog products, and are governed by the same stringent quality systems that support all our businesses. We utilized all knowledge and resources to support your project.


Why should I trust Bio-Techne with my service project?

We believe our industrial approach to custom product development significantly increases the probability of success, versus attempting development in-house or chancing a less qualified provider. Success rates on our service projects are >95%. Ultimately, this saves you precious time, and funding.


What should I expect if I start a service project with Bio-Techne?

Each service study is assigned a dedicated project manager whose role is to advocate for the customer and ensure clear and frequent communication between all parties. Projects start with a technical review where our key scientists listen to your specific goal/problem and apply all our understanding of the target, product type, and intended use to create a tailored solution. Typically, we will design a multipronged approach to maximize the probability of success. All elements of the study will be captured in a Statement of Work for the customer to review and approve. This document clearly records the work to be conducted, the specified deliverables, and the agreed timeline and price. To mitigate risk for both parties, most projects are divided into stage-gated phases, with payment on phase completion.

RD Frequently asked questions client processes


What happens if my project is successful? Can you support long-term supply?

Long-term supply of biological reagents (recombinant proteins, antibodies, immunoassays, etc.) is Bio-Techne’s core competence. We maintain hundreds of thousands of products in our catalog. The same processes and expertise will be applied to the maintenance and supply of your custom product. We can scale-up manufacture with consistence performance at an industrial level, because this is our business. This facilitates seamless progress to the next phase of your work without the need for Material Transfer Agreements or the development of new third-party relationships. Bio-Techne can also convert RUO products to GMP and provide GMP products for ex vivo human application.


What quality systems are in place at Bio-Techne?

For any custom product that is designed to support a diagnostic or therapeutic intended use, Quality Assurance and Quality Control are key. All of our custom products and contract services are governed by rigorous quality assurance measures, to ensure our customers can be confident in the accuracy of the data and the performance of our reagents. Most service work is conducted at our Minneapolis headquarters site, a 500,000 square foot, FDA-regulated facility.

Our policies conform with the requirements of:

  • The Code of Federal Regulations (21 CFR 820)
  • Quality System Regulations for Medical Devices ISO-13485 and ISO-9001
  • The In Vitro Diagnostic Directive 98/79/EC
  • Canadian Device Regulations
  • View our Quality Manual and Certifications

    • Do I need a Master Service Agreement (MSA) to work with Bio-Techne?

      It is not a requirement. To facilitate timely progress, we normally support preliminary studies with only a Statement of Work. However, if your organization requires a MSA prior to commencing a service project, we have a dedicated Legal team to execute agreements in an efficient manner. We are open to sharing our MSA template or reviewing your document. Successful service projects geared to long-term supply most often require the subsequent implementation of a Supply Agreement to formalize the commitments of both parties.


      How does Bio-Techne set service project timelines?

      We are generally conservative and realistic in the timelines we share. We have been generating proteins/antibodies/immunoassays for decades. Although there is a high chance everything will go smoothly, there is always the probability of an unforeseen scientific challenge. To mitigate this risk, most service projects are divided into multiple stage-gated phases with regular communication and project updates.


      What is the success rate for Bio-Techne service projects?

      Our success rate for service projects is over 95%. Because of the way potential projects are transparently discussed with the customer and a project plan clearly outlined, it is extremely rare that the agreed deliverable is not provided.


      How long has Bio-Techne offered services?

      Through the R&D Systems brand, Bio-Techne has commercially offered custom product development since 2013, and in situ hybridization assay services have been offered through the Advanced Cell Diagnostics brand since 2011. However, the experience and expertise supporting the development of recombinant proteins, antibodies, in situ and immunoassays goes back decades. Today, custom services through Bio-Techne are offered globally and supported by a highly skilled team of project managers.


      I’ve been purchasing R&D Systems reagents for many years, however now I see it being referred to as Bio-Techne. I’m confused, what is ‘Bio-Techne’ and how is it affiliated to R&D Systems or other individual brands?

      Bio-Techne is our parent company, a holding company for biotechnology and clinical diagnostic brands. R&D Systems is one of the companies and brands (among others) that are a part of Bio-Techne. Other brands within the Bio-Techne familiy include nine companies divided into two Segments:

      REMCOMBINANT PROTEINS

      General Services webpage

      What Protein Services does Bio-Techne Offer?

      Bio-Techne’s protein services are an extension of its catalog products from novel protein development to modification of existing catalog products. Novel protein development is performed as a one stop shop including cloning, transfection, expression screening, cell culture optimization, purification development, and characterization. Typical protein modifications include low endotoxin production, biotinylation, fluorophore conjugation, and Fc tag removal.


      What Expression Hosts does Bio-Techne use?

      Bio-Techne utilizes a variety of expression hosts including E.Coli, Insect, Mouse myeloma (NSO), Chinese Hamster Ovarian (CHO), and Human embryonic kidney (HEK293).


      How Does Bio-Techne Choose an Expression Host?

      Choosing an expression host can be a daunting task. Factors such as secretion efficiency, bioactivity, and post-translational modifications are among many factors that should be considered. Bio-Techne will choose a lead expression host based on published literature and draw upon internal production knowledge from having developed over 10,000 proteins. Many times, similar proteins have already been developed by Bio-Techne and similar strategies can be utilized. When suitable, Bio-Techne prefers to utilize a multi-host approach to further increase likelihood of success.


      Does Bio-Techne Guarantee Success?

      Success rates on Bio-Techne service projects are >95%. While we take a careful considerate approach to all of our projects, we do recognize that working with biological systems is never a guarantee. Bio-Techne cannot guarantee that all projects will be successful. However, all projects are stage-gated appropriately with go/no-go decisions to ensure financial and time commitments are protected.


      Does Bio-Techne offer Pharmaceutical Grade Proteins?

      Bio-Techne does not produce Active Pharmaceutical Ingredients (API). However, Bio-Techne does offer GMP production for ex vivo cell therapy. In the event that customers need true API grade material, Bio-Techne offers development services that can be transitioned to a 3rd party for API production.


      What if Bio-Techne Already Offers the Protein I’m Looking for but it Doesn’t Work in my Application?

      Bio-Techne aims to produce proteins that are properly folded and biologically relevant. Sometimes proteins of interest may have been developed many years ago before additional protein functions were known. We rely on customer feedback to ensure our proteins are working in all biologically relevant assays. If a protein is not working in your assay, please contact our technical services and we may be able to help.


      Does Bio-Techne offer Endotoxin Removal Services?

      Yes! Bio-Techne aims to be the leading developer of low endotoxin proteins. We recognize that endotoxin can be a major issue in certain applications. Bio-Techne offers low endotoxin production for customers that require stringent endotoxin specifications. We can commonly achieve endotoxin specifications of < 1 EU/mg and have achieved levels of < 0.05 EU/mg!

       

      PROTEIN MODIFICATIONS

      Protein Conjugation webpage

      My study is 2 years long. Can you support extended expiry for their protein on a custom basis?

      Normally, our recombinant proteins (and antibodies) have a guaranteed shelf-life of 12 months. We do have 2 options we can offer to extend the shelf-life of our proteins. The first is performing a bioassay test as the 1 year draws to a close to re-certify the expiry for another 12 months. There is the option of either sending back a vial or having a vial retained at our Minneapolis location for this purpose. Alternatively, we can perform and extended stability study for the protein. This is on a per protein basis and we can target an expiry of 24 months. This testing is performed in terms of timepoints, with the total number being determined by the passing or failing of each subsequent temperature/time point.


      What are the advantages of you performing my conjugation as opposed to doing it myself?

      There are multiple reasons why a custom conjugation project is a superior choice. First, you are leveraging our development scientists’ years of protein expertise. We also provide extensive QC validation, not just on the bulk product, but also on the final conjugated material. Lastly, you are going to save yourself time and internal resources by allowing our expert team to handle the conjugation. We ensure the final product is free of unbound conjugate and we have the capacity to scale up to meet ongoing needs.


      I cannot find a version of your protein in the catalog that matches my needs. Does this mean the only options is a development project from scratch?

      No! Oftentimes we may have produced alternative versions of a protein (e.g. with a different tag or expression system) but have never launched it as a retail product. Or we may be in the process of developing exactly what you need and could potentially sell you a sample on a pre-release basis. Many of these off-catalog products are readily available, with full QC testing already performed. If you reach out to the custom team, we can check on potential options and provide a prompt confirmation. If the material is available, it can be bottled and shipped in as little as 2-3 days!


      I need a His-tagged protein, what are our options for conjugating your catalog option to His?

      This is a common question and highlights an important distinction between our modification capabilities. In short, there are two type of modifications we can perform for a customer. The first is a conjugation. This is the attachment of an additional molecule(s) to the protein via a chemical reaction. The most common conjugation we perform is biotinylation, but we also have the capability to conjugate a selection of fluorophore dyes, and the PEG tag. These projects are relatively quick and less expensive, due to the process only being a chemical modification of an existing product.

      The second type of modification is on the molecular level, usually adding a tag in the form of an amino acid sequence. Some common selections are Fc tags, His tags, and the Avi-tag technology. Because the modification is on the amino acid level, it requires a new protein construct starting from scratch, and therefore entails the same lead-time and costs as a novel development.


      Can Bio-Techne help me test my compound in a cell-based assay?

      Yes! We have a wide variety of bioassays, including cell-based assays, enzyme assays, and binding assays. If you have a compound they want to test (such as an inhibitor) we can certainly design an experiment that leverages our existing protocols and reagents. We can go as far as to test an antibody or protein in a relevant assay to help them assess activity. Our QC bioassay service can support multiple samples, or even test uncommon components like a sample matrix.

       

      ANTIBODIES & ENGINEERING

      Antibody Services webpage

      Recombinant Engineering webpage

      What host animals do offer for custom antibody development?

      We have optimized our antibody development protocols over more than 20 years and we offer the generation of monoclonal antibodies in many host animals, including mouse and rat for monoclonal antibodies and rabbit, goat, sheep, chicken, and llama (camelid) for polyclonal antibodies. We produce most of our antibodies as mouse monoclonals as they are favorable to polyclonal antibodies for their consistency in supply and reproducibility in their intended application.


      How do I decide between a Rabbit or Goat Polyclonal Antibody?

      We identify the optimal host species for your custom antibody development project after an in-depth discussion to identify your custom antibody project needs. In general rabbits are easier, less expensive to manage, have a strong immune response and require less immunogen. The yield from a rabbit is estimated to be *25-100mg of purified antibody, this will be collected over 3 months and 5 bleeds (30-40mL/bleed). Goats are 7-8 times bigger than a rabbit and provide larger yields, this will be important for less batch to batch variation and long-term needs. The yield from a goat is estimated to be *100-200mg of purified antibody, this will be collected over 4-6 months and 3-5 bleeds (200-300mL/bleed). Another consideration to help determine host animal choice is your supply requirement over the long-term. For a larger, long term supply of antibody a goat maybe considered as the best option due to the larger yields and with a captivity lifespan twice that of a rabbit. However, due to the cost of maintaining a host animal for longer periods of time, converting your rabbit or goat polyclonal antibody to a recombinant antibody will immortalize your antibody supply will provide the best solution. *The yields vary and depend upon the immunogen, bleed number and the response of the animal.


      How much Immunogen do you need? What types of Immunogens do you use?

      We may need up to 5 mg of immunogen, although it depends upon the project, host species and immunogen type. For example, generating a goat polyclonal antibody using a recombinant protein, 1mg would be required for a 6-month protocol. There are multiple types of immunogens we use to generate antibodies.

      1. Recombinant and natural proteins are great choices for generating an antibody that works in multiple applications, is easy to purify/express and has low similarity to other proteins. Biological active proteins are suggested for use in generating antibodies used in ELISA pairs, blocking/neutralizing and for studying protein-antibody interactions.

      2. ii. Peptides are used if speed is important and the antibody applications include WB, ELISA, PTM, or if the target protein has a high sequence similarity to other proteins or is difficult to express. Good for recognition of linear epitopes. We have used peptides to generate antibodies to phosphorylated targets, specific epitopes, and conserved protein families.

      3. Transfected Cells are suggested for generating antibodies to GPCRs, multi-pass receptors, and antibodies used in flow cytometry.

      Immunogen Strategies & Intended Use

      Transfected Cells Biologically Active Proteins Peptides
      GPCRs ELISA Pairs Phospho Targets
      Multipass Receptors Blocking/Neutralizing Abs Specific Epitopes
      Flow Cytometry Protein Antibody Interactions Conserved Protein Families
      Largest Selection Largest Selection
      170 Targets
      270 Antibodies
      2500 SKUs
      35% of All FDA-Approved Drugs

      What is the Shelf Life of a Custom Antibody?

      A custom antibody has a 12-month warranty, we know from our extensive antibody manufacturing experience that our antibodies, if aliquoted in single use aliquots (to avoid freeze/thaw) and stored at – 20 degrees Centigrade, are most likely stable for longer periods, but we do not guarantee a warranty beyond 12-months. We do have custom service options to provide extended shelf life dating to customers with our customized stability studies. To do this we retain stock of a custom bottled lot for the customer and QC test every 6 months to provide an updated CoA. Another option is an accelerated stability study where we back-up the accelerated data with real time testing.


      Do you Offer Recombinant Antibodies and Antibody Engineering?

      Yes. We have an optimized platform for recombinant antibody development from scratch or to quickly convert an existing clone. We also have a proprietary expression system and modification library to engineer your recombinant antibody to meet your specific research goals. There are multiple benefits with recombinant antibodies, which include generating an immortal antibody supply, which is effectively “antibody insurance.” See the table below for more detail.


      Research & Manufacturing Challenges Recombinant Antibody Solutions
    • Inconsistency/drift
    • ✓ Sequence is locked down
    • Supply risk
    • ✓ Antibody becomes immortal
    • Can't engineer
    • ✓ Antibody is now fully modifiable
    • Time
    • ✓ Saves time versus hybridoma
    • Production expense
    • ✓ More efficient and cost effective
    • QA burden
    • ✓ Outsourced to R&D Systems
    • Yield/scalability
    • ✓ We can supply grams
    • Background issues
    • ✓ Engineer F(ab) or F(ab')2

      LUMINEX ASSAYS & ELISA

      Custom Luminex webpage

      Custom ELISA webpage

      How much does it cost/how long does it take to develop an analyte on Luminex?

      The first phase of most custom Luminex development projects are completed in approximately 8-weeks (e.g. adding 3 custom analytes to a panel of 12 total analytes, using existing R&D Systems reagents).

      Total costs and timeline involved in developing analytes on Luminex depends on several factors such as the level of development required (standard assay format vs. high-performance), specific performance parameters i.e., if a specific sensitivity level that needs to be reached, availability of reagents, among a host of other factors. There are several steps involved in development and depending on the specific requirements of the project, the total timeline and price may vary. A rough overview of the screening to kit assembly development process is below. The first phase of most custom Luminex development projects are completed in approximately 8-weeks (e.g. adding 3 custom analytes to a panel of 12 total analytes, using existing R&D Systems reagents).

      developing luminex analytes infographic

      However, we would be pleased to discuss your project through a call and provide estimates once we have a better idea of your needs. All elements of the study will be captured in a Statement of Work for the customer to review and approve. This document clearly records the work to be conducted, the specified deliverables, and the agreed timeline and price. To mitigate risk for both parties, most projects are divided into stage-gated phases, with payment on phase completion.

      As a biological reagent development and manufacturing company, we are able to utilize our internal antibodies and proteins to develop our Luminex assays as compared vs. other CROs, which not only saves valuable time and money as compared to sourcing reagents from a 3rd party but also ensure that we are able to maintain control over quality and supply of your reagents.


      How can Bio-Techne support my long-term study using the Luminex platform?

      To ensure a smooth and efficient workflow, for your long-term studies involving analyzing multiple markers over a period of time, Bio-Techne offers various custom services as mentioned below:

      1. Lot Sequestration: Use the same lots of kits to minimize any variations from lot changes.

      2. Bulk Packaging: Minimize packaging waste by receiving kit components in flats instead of individual tubs.

      3. Bead Region Conflicts: Cut down the number of panels you need to run by resolving any Bead region conflicts that may come up.

      What if Bio-Techne does not have antibodies or proteins for a target I want to develop?

      Bio-Techne can either initiate a custom antibody and protein generation project for further use in an immunoassay or collaborate with a 3rd party to source the necessary reagents. The former option is preferred to avoid delays or impact from licensing negotiations and to ensure we are able to maintain control over our supply and quality of these reagents to mitigate any impact on supply in the future.


      What happens if my targets are not suitable for Luminex?

      Bio-Techne has a wide variety of immunoassay and ELISA platforms such as Duoset, Quantikine, and Ella depending on your specific needs and requirements. We have also successfully leverage our Flow Cytometry scientists to analyze biomarkers in different samples types for projects that include measuring targets that are unsuitable on immunoassay/ELISAs.


      Can you support IVD/LDT development?

      All products and services provided initially will be for Research Use Only (RUO). However, we have the technical expertise to support such projects and would be pleased to do once appropriate licenses have been obtained.

      For any custom product that is designed to support a diagnostic or therapeutic intended use, Quality Assurance and Quality Control are key. All of our custom products and contract services are governed by rigorous quality assurance measures, to ensure our customers can be confident in the accuracy of the data and the performance of our reagents. Most service work is conducted at our Minneapolis headquarters site, a 500,000 square foot, FDA-regulated facility.

      Our policies conform with the requirements of:

      • The Code of Federal Regulations (21 CFR 820)
      • Quality System Regulations for Medical Devices ISO-13485 and ISO-9001
      • The In Vitro Diagnostic Directive 98/79/EC
      • Canadian Device Regulations
      • View our Quality Manual and Certifications

      What are the differences between LUMINEX and ELISA testing?

      There are pros and cons for both the ELISA and Luminex platforms. ELISA results are viewed as being quantitative and reproducible, but also require more sample volume and are more expensive per result. LUMINEX results are viewed as semi-quantitative, with more lot-to-lot variation, but allow for the detection of multiple analytes in a single run using less sample volume and are less expensive per result.

      Differences between the two platforms are also summarized in the table below:

      Luminex (Performance) (Quantikine) ELISA
      Measures multiple analytes in a 50 uL sample volume in one well of one assay, which is ideal when available sample volume is very low. Each analyte must be measured in a separate assay, with up to 200 uL of sample volume needed per well, which is not a concern when sample volume is plentiful.
      Some optimization of assay conditions and diluent formulations is performed to ensure good performance, but cannot be fully optimized for each analyte because they must be compatible with every analyte on the panel. Assay conditions and diluent formulations have been highly optimized to ensure that they are ideal for the one analyte being measured.
      The standard curve range and lower limit of quantification can shift for each lot. The customer must check the standard value card of each kit for the curve ranges of each lot. The standard curve range and lower limit of quantification are consistent for every lot.
      % Recovery and linearity results for validated sample types vary based on analyte and sample type. Recovery is usually between 70-130%, but can sometimes range from 50-150%. % Recovery and linearity for validated samples is almost always between 80-120% for all analytes, with only rare exceptions.
      Lower cost per data point. Higher cost per data point.
      Assay is run using a Luminex 100, Luminex 200, BioRad BioPlex, or Luminex MAGPIX. These are expensive instruments that many labs may not have access to. Assay is run using a spectrophotometer, which most labs already have.

      What are the typical phases and estimated timelines for ELISA Development?

      ELISA Assay Development

      Phase Timeline
      Phase 1: Ab pair selection 6 - 8 weeks
      Phase 2: Feasibility 8 - 10 weeks
      Phase 3: Optimization 10 - 12 weeks
      Phase 4: Validation 10 – 12 weeks
      Phase 5: Supply 4 - 6 weeks

       

      CUSTOM MEDIA

      Custom Media webpage

      Why should you choose R&D Systems to manufacture your Custom Media?

      Our in-house formulation expertise enables us to provide a consistent and reliable source of Customized Media products for your applications and processes.

      To create a customized solution, researchers can choose one or more of the following options:

      • Modification of a current catalog product
        Modify an existing catalog base media, balanced salt solution, liquid media, or supplements to add or remove components (subject to review).
      • Customized Packaging
        Our packaging options are flexible and are available in a variety of volumes and formats, including vials and bottles.
      • Additional Quality Control Tests
        R&D Systems can perform a variety of additional testing, such as endotoxin, mycoplasma, and functional testing.

      What are the typical lead times and minimum order requirements for Custom Media?

      Media Type Minimum order Typical lead time
      Liquid media 6 L 6 - 10 weeks
      Powdered media 20 L 4 - 8 weeks

       

      GMP / Cell & Gene Therapy

      CGT Custom webpage

      Quality Documents webpage

      Retail GMP proteins webpage

      Does Bio-Techne have capabilities to manufacture GMP grade reagents?

      Bio-Techne currently has a wide range of GMP proteins, antibodies small molecules, media, and Cloudz microcarrier in the retail portfolio. These products are supported by R&D Systems and Tocris brands. Along with the current retail offering, Bio-Techne offers services to manufacture new Research Use products with the intent to convert to GMP, as well as convert current research use products to GMP.


      How does Bio-Techne offer a full-service solution for RUO to GMP?

      By leveraging 40+ years of product development and our team of scientists, Bio-Techne is able to offer RUO and GMP development. By using the same team for both workflows, we are able to mitigate risk and save time. This helps to avoid tech transfers and increases the chance of success for validation of process and GMP manufacturing. Our ISO regulated facilities and new state of the art GMP manufacturing site are compliant with regulatory needs to ensure our products can meet the required FDA standards.

      https://www.rndsystems.com/products/gmp-quality-policy-and-regulatory-support

      https://www.rndsystems.com/products/gmp-cell-and-process-development


      Can Bio-Techne provide GMP product that can be utilized in a clinical trial?

      Bio-Techne proteins and products are intended for use in ex vivo applications and are currently in use in clinical trials around the world. These products are intended for use in preclinical development through your clinical trial. Depending on the country of origin, each regulatory body will need to properly vet the products to ensure compliance with clinical regulations.


      What is the standard timeline for a GMP conversion?

      GMP conversion timelines can be variable based on where you would like Bio-Techne to begin the process. By starting with RUO and moving to GMP, we ensure yield and function meet your needs. By appropriately stage gating our Statements of Work that define the project, BT is able to mitigate the risk to you and provide optimal service to ensure we meet your presented timelines. Please contact your local sales consultant for additional information on timeline based on your specific needs.


      Can R&D Systems support regulatory filings with the FDA?

      R&D Systems currently supports multiple Drug Master Files (DMFs) with the FDA. This is a service that is offered for custom reagents as well to ensure expedient and accurate information transfer to the FDA for review in reference to your companies IND.

      Custom ProDots

      CGT Custom webpage

      ProDots webpage

      What is a ProDot?

      ProDots are R&D Systems proteins neatly packaged into easy-to-use balls that can be rolled into cell culture media or contained in cell culture media bags for a closed system to add cytokines to your media. Less handling, less variability.


      What is the benefit of a ProDot?

      ProDots are easier to use and come in smaller sizes than current retail proteins. This helps to save time and provide a more consistent dose for your application. The same bulk recombinant protein material utilized to manufacture product in vials are utilized in our proprietary manufacturing process. This ensures consistent results from RUO to GMP to support further manufacturing needs.


      How can closing the system help to minimize risk?

      By using our ProDots in a Bag, you can minimize operator error and risk of introducing contamination to your system. Closing this part of the process ensures the desired concentration of cytokine is always delivered to your cultured cells.


      What are the different formats ProDots can be provided in?

      ProDots can currently be supplied in a vial or in a closed system bag. The container, size, and testing can all be customized based on your specific needs to support your development and further manufacturing initiatives.


      How does ProDot QC testing differ from recombinant protein testing?

      The ProDot is tested at every stage of manufacturing. The bulk material, dot intermediate, and final packaged product are all evaluated in a specific set of assays for that product. Whether a recombinant protein in a vial or a ProDot in a bag, you can be confident the product will meet specifications and remain consistent through your development through clinical manufacturing workflows.


      Can you make custom GMP ProDots?

      R&D Systems currently offers GMP Prodots on the retail catalog. We also offer GMP conversion services and RUO customization to fit the product to your process. Please contact your local Cell and Gene Therapy Sales consultant for additional information on timeline based on your specific needs.

      RNAscope, BaseScope, and miRNAscope histopathology

      ACD Services webpage

      What is unique about RNAscope, BaseScope, and miRNAscope in situ hybridization?

      Advanced Cell Diagnostics’ (ACD’s) RNAscope® family of assays are novel in situ hybridization (ISH) assays for detection of target RNA within intact cells. The assay represents a major advance in RNA ISH approaches with its proprietary probe design to amplify target-specific signals but not background noise from non-specific hybridization. The RNAscope and BaseScope assays employ a probe design strategy in which two independent probes (double Z probes) must hybridize to the target sequence in tandem in order for signal amplification to occur. As it is highly unlikely that two independent probes will hybridize to a non-specific target right next to each other, this design concept ensures selective amplification of target-specific signals. miRNAscope probes enable detection of endogenous miRNAs as well as therapeutic ASOs and siRNAs.

      RnD RNA scope in situ hybridiczation infographic


      What histopathology services are provided at ACD?

      ACD provides end-to-end service solutions, including sample sourcing, sample preparation and embedding, sectioning, ISH services, scoring and image analysis, and reporting. Services are performed by our Pharma Assay Services (PAS) group with labs in Newark, CA. The PAS team has nearly a decade of experience running thousands of projects, and the dedicated team of specialists, scientists, and pathologists is unsurpassed in their experience with the RNAscope family of assays.

      ACD histopathaology infographic


      What is the typical turnaround time for a project?

      Standard projects are delivered within 4-6 weeks of sample receipt, including sample processing, ISH staining, semi-quantitative scoring, and reporting.


      Does ACD have experience developing clinical assays?

      The ACD PAS team has developed hundreds of biomarker assays and has supported over a dozen clinical trials in just the last three years. ACD has partnered with Leica Biosystems to develop CDx and Dx tests using fully automated RNAscope, BaseScope and miRNAscope in situ hybridization (ISH) assays that require minimal hands-on time. The PAS team can develop and optimize assays that meet the FDA Bioanalytical Method Validation guidelines. Technology transfer and cross-validation studies can be performed to ensure successful assay transfer to a CLIA facility. All assays performed by the PAS team leverage our regulatory compliance expertise, and the labs are now operating under Good Clinical Laboratory Practice (GCLP) guidelines.


      Does ACD have access to pre-qualified tissues?

      ACD’s PAS group has built a Tissue Bank containing a set of high quality, pre-sourced and pre-qualified samples, available to our PAS customers. The sample inventory includes diseased and matched normal (NAT) tissues from various indications including solid tumors, NASH, psoriasis, and IBD, as well as animal tissues including mouse, rat, and cynomolgus monkey.


      Can ACD develop a custom assay to evaluate a novel target?

      Probes against novel targets can be designed in a matter of 1-2 weeks, and a custom assay can be developed by the PAS team within the standard timeframe of 4-6 weeks. The PAS team has developed hundreds of assays for AAV- or lentivirus-delivered transgenes, engineered CAR-T and TCR T cells, targets with poor antibodies, and most recently, therapeutic siRNAs and ASOs.