ADA Assay Considerations: Rely on Sword Bio’s Unparalleled Expertise

ADA Assay Considerations

The Positive Control (PC) reagent is pivotal when embarking on a new anti-drug antibody (ADA) assay. Regulatory agencies typically favor polyclonal PCs because they represent the in vivo immunological response. While they have accepted monoclonal PCs, they often inquire about the rationale behind this choice. For straightforward biotherapeutics, a simple explanation suffices. However, as the complexity of the biotherapeutic increases (Bispecific, multisite additions, etc.), the use of monoclonal antibodies as PC reagents becomes more intricate.

Polyclonal Antibodies

Polyclonal antibodies can be obtained from Rabbits, Chickens, or other species. Rabbits and Chickens are the two common species that obtain polyclonal antibodies. The key here is not to completely bleed out a rabbit but to use 3 to 4 rabbits, keeping the subjects alive. Then, a select amount of serum from all the subjects is used to get a better pool of polyclonal antibodies. Chicken IgYs are obtained from the eggs, and the eggs from 3-4 chickens can be pooled together to obtain a good number of polyclonal antibodies. This will reduce the re-evaluation time for the new polyclonal lot, which should be the same as the original polyclonal going forward. This will also permit reliable affinity purification of the polyclonal antibodies to different therapeutic parts. They save time and are cost-efficient.

Understanding Your Needs: Sword Bio’s Thorough Approach to Asking the Right Questions

In establishing drug tolerance, Sword first asks the client about the dosing concentrations and if they have an idea of the therapeutic’s half-life. This will give us an estimated therapeutic drug concentration, which we can check to see if we can determine at least 100 ng/ml of ADA PC (per FDA guidance) at the requested therapeutic concentration.

Sword Bio’s comprehensive approach ensures a well-developed assay for our clients—from start to finish. We meticulously consider all critical reagents, the associated items that might be affected, and the elements we want to identify for our customers. By establishing these things early on, we prevent the need to backtrack. We address each aspect precisely and then move forward with the assay, maintaining flexibility and continuous client interaction throughout the project.

A Mid-size CRO with Flexibility in Start Times and Communication

Sword Bio is a mid-size CRO that can adapt to small biotherapeutic clients, serve the needs of medium-sized biotherapeutic clients, and scale to the demands of large pharma for any of their ADA assessments. Because of our experience and flexibility over the process, we can anticipate workflows, which allows us the flexibility to start incoming projects much faster than organizations multiple times our size. We can get plate maps out to the clients before receiving all the reagents before moving forward. Since we actively seek feedback and communicate with our clients, we are in a better spot than most other CROs.

The Right Technology with the Right Level of Expertise

Everyone in this space uses the same technology platforms, and Sword Bio is no exception. We are aligned with the same instrumentation and technology that all CROs of any size would employ to address these ADA assays. We have the same state-of-the-art platforms and can use the same techniques. We are on par or above par compared to virtually anyone within the industry. Our ability to remain nimble and flexible, while providing the same level of quality and scientific expertise as our competitors, gives our clients the advantage.

Instead of making our clients fit a specific “mold,” which is often the case with a larger organization, our customers take a more collaborative approach with us. We work as an extension of their team, utilizing the best equipment to accomplish precisely what they need for their project(s).

With Sword Bio, our Customers Get Science, Communication, and Speed.

Typically, clients within this industry receive only one or two qualities when selecting a CRO: Speed, Communication, or Cost. With Sword Bio, we genuinely offer our customers all three.

By thoroughly communicating with our client about their therapy from the outset – where it binds, how it binds plasma tissue, etc. – we can ensure the project stays on track, saves time, and is more cost-effective. We establish all the reagents based on what we’ve learned from that client. Then we purchase commercial reagents, or we can support generating the client’s reagents for them, unless the client already has the reagents.

Once that has been established, we can start immediately because of our pod system. Our pod system is essential because it doesn’t interfere with other clients or other types of assays being done. Our customers start with their PI and a team that stays with their method development through the sample analysis of the ADA, ensuring quality every step of the way!

This ensures that no “handing off” or unnecessary transferring of any information is needed. The same team goes with you through the entire process – through SOPs and everything else.

The Newest AI Statistical Solutions Employed to Analyze Data for your Project Success Precisely

One significant time-delaying aspect of ADA assays is the statistical analysis for the cut point and the LPC, determining biological and analytical outliers, and how to use signal-to-noise data.

Employing the latest technology available from Red Thread, which uses an AI system to analyze all the various attributes of the assay and statistical analysis to put it all together, this software can do in just a couple of days what takes most companies anywhere from a week to two weeks. Additionally, Red Thread automatically puts all the statistical analysis into a report for us, and we attach it to our customers’ validation reports, which the FDA has accepted.

Sword Bio is Ready for Your Project now!

Sword Bio has a lot of capacity because we structure our incoming projects and client needs using the pod system.

Suppose you are getting into your IND and must produce an NHP toxicology and risk assessment of your PK for phase one. In that case, you will also need the NHP ADA to establish the concentration of your drug in the non-human primate toxicology studies. While many CROs may report starting times from six to nine months from now, Sword Bio can start this for you and your team ASAP.

Set up a time today to meet with a Sword Bio specialist and prepare to be impressed.