Fit-for-Purpose Insourcing Solutions

The RightSource program is a novel, first of its kind insourcing solution serving biotech and biopharmaceutical companies with the panel of assays they deem most necessary for their biologics manufacturing program to have on site.

Unlike standard staffing solutions, our business model offers clients the expertise to bring our proprietary assays in-house with the same quality and scientific platforms used at our centralized locations. Having a RightSource program at your facility enables you to leverage our wider network when you need it most; this includes regulatory, scientific consultation, and biologics testing support.

Primary Testing Capabilities:

  • Microbiology testing and services
  • Process development testing and support
  • Analytical GMP release testing
  • Method development and validation
  • Environmental monitoring
  • Project management

How We Partner

Instead of you managing a testing lab from inception to GMP status, we provide all the scientific staff as well as proprietary SOPs, methods, and systems to establish and run your dedicated QC lab faster than ever before. The platform can be tailored to your needs making testing easier, faster, and more reliable. Our agreements are structured so that you're in control of the time commitment based on the scope of work, forecasts, and performance. Best of all, you can sleep easy at night knowing that we bear all regulatory burden associated with your RightSource lab.

Scope of our Work

  • Cell and gene therapy
  • Biologics and biosimilars
  • Bispecific antibodies
  • Fc-fusion proteins
  • Lipid nanoparticles
  • Viral vectors
  • Novel modalities

Our Biopharmaceutical Partners

  • Drug developers and manufacturers
  • Incubators and accelerators
  • Commercialization centers
  • CMO’s and CDMO’s

Frequently Asked Questions (FAQs) About RightSource Biologics Insourcing Solutions

  • Where is the lab located?

    The lab is located at the client facility but is entirely run and managed by Charles River.

  • We already have a Quality Management System; can we just use that?

    Yes, but the value we can provide is diminished. As soon as the lab is no longer segregated, the certificate of analysis will be from you as the client and not Charles River. All SOPs and methods will then need to be the clients.

  • How do we access the data?

    The data or certificate of analysis would be similar to a typical outsourced relationship where the sample is provided by the client and we provide the certificate of analysis and report. If there is a desire to have a technical integration, we can arrange that.

  • What if I don’t have space at my site?

    If you still want the dedicated service, we can provide a dedicated FTE model at one of our locations if the volume is high enough.

  • How long are RightSource contracts?

    We typically have longer-term contracts (in terms of years) since there is significant investment in people, equipment, IT, and procedures. This is all determined by the scope of the contract.

  • Are you a staffing agency?

    No. We provide people as a part of the complete solution, but we typically do not provide only people. There is the possibility of certain arrangements as a part of a broader contract, but these are the exception and not the rule.

  • When is a good time to consider RightSource?

    RightSource can be integrated at any time, but a great time to consider implementation is when a new manufacturing facility is being designed or an existing one expanded. This allows us to provide the full value proposition of having us onsite equipped with all of our best practices, SOPs, methods, and systems.