The pandemic has forced the world to change how business is conducted. As an essential service, ITR has had to adapt quickly to ensure that the development of crucial treatments to solve the pandemic remain on track. ITR’s crisis management team has been meeting frequently to identify what preventative measures needed to be taken to optimize the protection of our staff and to safeguard the work we are performing for our clients. Of paramount importance is to exclude the virus from the facility by providing safety measures in line with global guidance available to us.

Going forward, ITR has established a virtual audit plan to provide a substitute for in-person visits to the facility as needed. This includes providing sponsors with remote access to important documentation, as well as a virtual tour of the facility.

In this newsletter, we will discuss how ITR has adapted to protect our staff from COVID-19, we will detail our virtual audit plan, we will describe various upgrades and extensions to the facility and finally we will discuss ITR’s future plans.

COVID-19 Policy changes

In order to protect our staff from the virus, ITR has increased sanitation depth and frequency around the facility as well as increasing awareness of appropriate hygiene controls. Multiple new hand sanitizer dispensers have been installed around the facility. Office areas, laboratories and common areas have been re-arranged to ensure appropriate physical distancing practices. Plexiglass dividers have been installed to provide physical protection between lab stations and between desks in open office areas.

We have also introduced staggered shift times to reduce traffic in and out of the facility during operating hours. In line with government recommendations, all staff are provided with a weekly supply of masks to wear in the common areas or in their respective laboratory workspaces.

Visitors to the facility are asked to wear the provided PPE to minimize risk of exposure and business interruption. Visitors are also asked to fill out a COVID-19 screening questionnaire to evaluate the risks associated with the visit. All incoming deliveries are sanitized before they are released internally.

Virtual Audit Plan

The state of the virus and the response from governments globally has made business travel impossible to this date. Since sponsors can no longer visit the facility, ITR has established a virtual audit plan to provide sponsors with the opportunity to remotely review important documents and to evaluate how the facility operates. Under normal conditions, visiting sponsors would be given access to all our SOPs and other facility documents on site for them to perform an audit of how our work is performed. Today, we can offer sponsors remote access to these documents so they can evaluate the scope of what ITR has to offer.

In addition to revision of SOPs, ITR is currently working on the production of a virtual tour of the facility. The virtual tour is designed to offer a substitute experience to an in-person visit; the tour offers a walkthrough of our various laboratory spaces including the pharmacy, immunology, clinical pathology, analytical/bioanalytical and PK/TK laboratories. The tour will also cover various areas within the vivarium, including the surgical suite, veterinary care suite as well as an example of our animal rooms and anterooms. We will also display some of our inhalation equipment.

Facility Updates

Towards the end of 2019 and the beginning of 2020, ITR underwent a series of upgrades and expansions. The first project was construction of the new expansion at the front of the facility. This expansion provided new office spaces for our IT department, report production and pathology.

Pharmacy Expansion

The office spaces for pathology and report production were repurposed to extend our pharmacy, adding more than double the physical space.

Clinical Pathology

Our clinical pathology department has recently validated new clinical chemistry measures related to iron including: unsaturated iron binding capacity and total iron binding capacity. Iron is an essential nutrient that, among other functions, is required for the production of healthy red blood cells (RBCs). It is a critical part of hemoglobin, the protein in RBCs that binds oxygen in the lungs and releases it as blood circulates to other parts of the body. The serum iron test measures the amount of iron in the liquid portion of blood. Serum iron is almost always measured with other iron tests, such as serum ferritin, transferrin and total iron-binding capacity (TIBC). These tests help diagnose and/or monitor iron deficiency anemia or iron overload.

The Iron (Fe) and Unsaturated Iron Binding Capacity (UIBC) parameters had never been analyzed at ITR. The Clinical Pathology department has now successfully validated these two new chemistry parameters. In addition, the results of Fe and UIBC combined together gives the Total Iron Binding Capacity (TIBC). These new parameters can now be added to the long lists of already existing chemistry parameters and can easily be analyzed on the Cobas c311 chemistry analyzer on sponsor’s request.

Immunology

The purchase of a Mesoscale discovery quickplex plate reader in 2019 has enabled ITR to vastly expand our list of validated biomarkers. In the last few months the list of available biomarkers has increased more than 8 times its original size. For an up to date list of biomarkers click Here.

Analytical & Archives

The archives at ITR are currently under renovation to provide more space for archived materials, while also opening up more space for the analytical department. Previously un-used storage space has been divided, converting a portion to a temperature & humidity-controlled area fit for archiving biological materials, while the remainder will be used for the installation of a new analytical mass spectrometry laboratory. In addition, the services of our dose formulation have been expanded to include the latest Empower Software from Waters with their ACQUITY UPLC H-Class PLUS System, which is the next evolution of UltraPerformance instrumentation. It operates at the ultra-high pressure of 15 000 psi, which is equivalent to the pressure at 11 km below the ocean surface. The high pressure tolerance permits the use of HPLC columns with ultrasub 2 µ particle sizes. ITR will be able to provide a combination of increased resolution, sensitivity, and speed of analysis that comes with the modern small particle chemistries. In the near future, the new bio-analytical room will be able to house four more up-coming sensitive mass spectrometers as well including a new Sciex QTRAP® 6500+ System.

Conclusion

Despite the global shutdowns resulting from the novel coronavirus, ITR has maintained operations and we are actively participating in the development of safe and effective solutions for COVID-19. ITR will be expanding further in the summer of 2020 to provide more office spaces for the marketing & business development teams. Staff safety remains our top priority and ITR management is continually assessing the state of the virus and updating policy to protect the health and well-being of our hard-working staff.

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