+1 (888) 794-0077

Beyond Standard Testing: Exploring the Benefits of Custom Preclinical Solutions

Apr 5, 2024 | Manufacturing, MDR, Medical Device, Medical Device Testing, Regulatory

In an increasingly complex world, one size rarely fits all. In most preclinical studies, testing services can be bought off-the-rack and fulfill all the needs and desires of a device manufacturer or drug developer/sponsor. But sometimes, a custom fit is necessary. WuXi AppTec offers customized, state-of-the-art services for preclinical studies, which support product development, regulatory submissions, and marketing claims. Here, we explore the level of custom services available and why they are crucial to product research and development. 

The cornerstones of customized preclinical testing

The landscape of preclinical testing services presents a conundrum: standard services versus tailored solutions. The distinction lies in the degree of customization. Standard testing services offer broad applicability but limited flexibility or nuance. In contrast, customized testing provides a boutique experience, fostering closer and more detailed collaboration between clients and scientists to meticulously define project-specific requirements and create solutions.

Navigating preclinical studies can be a complex endeavor, marked by unexpected developments and shifts in direction. Clients must have confidence in their testing facility’s commitment to transparency and efficiency. Trust in this context is not merely about adherence to timelines and protocols but also about the agility and adaptability of the testing process.

One of the cornerstones of seamless custom testing involves the early and continuous involvement of a multidisciplinary team of experts, including preclinical scientists, surgeons, veterinarians, pathologists, and toxicologists. Their role extends beyond scientific consultation to include pragmatic, real-world solutions tailored for unique study designs.

Involving these specialists from the project’s inception is not just a proactive measure for issue prevention; it’s a strategic move to enhance the study’s efficiency and reliability. This foresight optimizes the immediate research process and ensures the generation of robust, credible data capable of withstanding rigorous scrutiny long into the future.

Practical advantages to customized preclinical testing 

Engaging in tailored preclinical studies presents a range of advantages for device manufacturers and drug developers. A prime example of this is the integration of efficacy and biocompatibility endpoints within a single study framework.

While this approach has advantages and challenges, its success hinges on meticulous planning and execution, potentially conserving valuable resources. It requires a comprehensive understanding of the client’s immediate and long-term objectives and a thorough evaluation of the sample product’s design and its historical testing background.

Tailored preclinical studies expand the possibilities of using in vivo and in vitro models to specifically address the unique aspects of product applications. WuXi AppTec can also lean on specialized models to fill niches not adequately covered by standard testing protocols, including:

  • Routes of administration or surgical models to mimic intended clinical use,
  • Orthobiologic models for bone repair,
  • Excisional wounds for advanced wound care analysis,
  • Bacterial infection models to test antimicrobial efficacy,
  • Subcutaneous tumor models for oncology research,
  • Adapted standard biocompatibility tests for more specific material interactions.

WuXi AppTec’s study-specific models combine the latest scientific literature with its team’s extensive experience in model development. Client representatives are often invited to participate on-site during development, facilitating direct training and ensuring a seamless transition from benchtop experimentation to in vivo model development.

This collaborative approach enhances the transition phase and ensures that drug developers and device manufacturers have a consistent, replicable foundation for initiating pivotal Good Laboratory Practice (GLP) studies, thereby bolstering the robustness and reliability of their research outcomes.

Future-proofing customized testing

One way to future-proof customizable preclinical testing services is to scrupulously maintain the sophistication and integrity of animal facilities. This demonstrates a commitment to precision, reliability, and ethical practices in all research endeavors.

WuXi AppTec’s facilities are maintained through rigorous and regular inspections by various regulatory agencies, alongside client and internal department audits. Such thorough oversight ensures that WuXi AppTec’s team is consistently engaged in a process of learning and improvement.

Equally important to the company’s strategy is an ongoing investment in the professional growth of its staff. This includes refresher training, new skills development, and continuing education, ensuring the team remains at the forefront of evolving practices in customized preclinical study services. WuXi AppTec also prioritizes employee satisfaction and retention, recognizing that a motivated and stable workforce is essential for preserving valuable experience and providing a continuity of knowledge for future projects. This commitment extends to a meticulous vetting process for subcontractors, ensuring that every aspect of the service ecosystem aligns with the company’s stringent quality benchmarks.

A final word

In a world where change is the only constant, customization emerges as a critical element, particularly in preclinical studies. Recognizing that not all research inquiries can be adequately addressed by standard, off-the-shelf solutions is central to this understanding.

WuXi AppTec’s custom preclinical testing services offer clients a simple yet profound advantage: flexibility and expert guidance. This unique combination empowers drug developers and medical device manufacturers to embark on ambitious preclinical studies that may deviate from the norm or entail greater complexity. WuXi AppTec’s expertise is a resource and a catalyst, enabling clients to navigate the intricacies of bespoke preclinical studies with assurance and precision.

Click to learn more about WuXi AppTec’s custom preclinical testing.

Related Articles