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Preclinical Drug Discovery | InVivo Biosystems

Biological Quality Control Assay Validation Services

New Product Development Validation Services

InVivo Biosystems is equipped with a technology platform and expert team ready to assist your organization with Biological Quality Control and other New Product Development validation testing needs.

As a Contract Research Organization (CRO), Our expert team has assisted industries with various product development and manufacturing service needs, including but not limited to: 

  • Supplying biological materials for quality control testing
  • Understanding the Mechanism of Action (MOA) for a reagent or compound
  • Quality control assay design
  • Quality control assay validation
  • Quality control assay reconfiguration

Your Partner for Go-To-Market Excellence

In an evolving biotechnology market, rapid cycles of developing and launching new products poses an exceeding need for assistance with validation testing before and after launching a new product. Barriers to execution are unique for any product launch, but the reasons for delay of go-to-market dates and/or Quality Control issues for any new product within the biotech industry typically boil down to the following:

  • Validation testing during product development was delayed due to lack of resources in the lab.
  • Unexpected R&D delays occur, leaving too little time for proper 3 phase validation testing of a new product before launch.
  • R&D develops a novel product, but the proper Quality Control test(s) and/or failure modes remain undetermined even after product launch. 
  • A new product development team designs a new instrument or reagent product, but needs to procure animals or other biological materials to validate and perform on-going Quality Control testing on each batch of product once launched.

Regardless of which of the above obstacles your team is seeing, the InVivo Biosystems team may be able to partner with you to assist in lowering your product development barriers to execution.

Quality Control Assay Design and Validation

During New Product Development (NPD), the R&D resources required for creating a functioning product in and of itself is a challenge. After developing a stable functioning product, the questions then become:

  • What Quality Control testing is necessary and sufficient for this product?
  • How scalable is our product? (i.e. What should the minimum and maximum build sizes be?)
  • How do we acquire the resources necessary to validate our assay in time for product launch?

Answering these questions when developing a product while hitting target launch dates is a struggle for even the most experienced industry professionals. Often, decisions have to be made to compromise time or quality, but it is always preferred to ensure a quality product while executing on committed deadlines.

The InVivo Platform Advantage

RNA-Seq Global Gene Expression:

Depending on what your product is and your validation requirements, we have animal and non-animal models along with numerous patented technologies to apply for designing and/or validating an assay. One example is our RNA-Seq Global Gene Expression study. Our RNA sequencing is unique compared to other companies due to our capability of providing a global gene expression transcriptome, which provides a basis for understanding mechanism of action, target identification, or biomarker identification for your product.

Learn more about our RNA-Seq Global Gene Expression study HERE

Understanding Mechanism of Action (MOA):

The InVivo Biosystems team has assisted numerous companies with understanding the mechanism of action (MOA) of their reagent or compound to adhere with FDA regulations. To understand MOA, our team will typically perform an RNA-Seq Global Gene Expression study, followed by testing of an industry’s assay on a transgenic model which we use our patented technology to produce in-house. RNA-Seq paired with assay testing on a transgenic model delivers our customers with an extensive set of data for understanding the site of action (SOA) for the reagent or compound.

Learn more about our MOA expertise by visiting the links below:
Preclinical Compound Efficacy Testing Service | InVivo Biosystems
Testing the efficacy of JadeAging®, a Chinese Medicine based longevity formulation, using InVivo Biosystems’ suite of in vivo platforms – InVivo Biosystems
Where the Lead Leads: Seeking Mechanisms of Action in C. elegans for Neurotoxic Effects of Lead – InVivo Biosystems

Large-Scale Assay Validation Test:

Do you simply not have enough sets of hands in the lab, and/or need to perform multiple tests for quality assurance of your product? Our rapid testing team of experts is ready to assist and provide solid 3 phase validation testing of your product. 

Improvement of Existing Products:

Do you have a product with regular quality issues? Our team has helped companies diagnose quality issues for multiple types of products (sgRNAs, DNA, etc.) by designing and executing toxicity or compound testing. We design the new Quality Control assay and perform the testing needed to validate any new testing procedure and/or determine the source of a product’s quality issue. 

Procurement for Quality Control Testing

Another common barrier to execution when developing a new product is the need for procuring all necessary materials for testing in addition to procuring materials for manufacturing. Creating a new supplier relationship is a timely process which leaves room for many delays, especially when procuring biological materials such as organisms, RNA, DNA, etc. 

Being in contact with the right supplier and acquiring the proper materials for manufacturing and Quality Control testing remain as a large issue for biotechnology industries worldwide. If your team is encountering procurement issues, we may be able to help. With our patented CRISPR technology, we produce both wild-type and genetically modified C. elegans and Zebrafish organisms at large-scale which are capable of being used to test various assays at a low cost.

About The Author

Ally Wimberly

Ally Wimberly is the Manager of Marketing and Sales Operations at InVivo Biosystems. Ally has diverse experience in both academia and biotech industry, and in her industry experience has been successful in both Operations and R&D roles. She leverages her product development, project management, and quality assurance expertise in her current role at IVB.

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