Genetic Engineering & Biotechnology News

DEC 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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10 | DECEMBER 2018 | Genetic Engineering & Biotechnology News | GENengnews.com Marty Pittman As cultural and legislative support for the cannabis industry continues to grow around the world, many laboratories are adapting their testing capabilities to meet rising customer demand. To make this emerging opportunity a success, labs must navigate a constellation of business needs and regulatory im- peratives. These include: Maximize return on investment (ROI). The cost of instru- mentation is high, and margins are low. To reach revenue targets, labs must operationalize a highly efficient, reliable, and reproducible end-to-end workflow. Maintain compliance. In the United States, adjacent states have divergent (and frequently revised) regulatory demands, while labs themselves have internally driven QC standards. Efficient teams require a system capable of supporting inter- nal and external compliance measures. Acquire and retain strategic customer relationships. The cannabis testing industry, defined by competition and ag- gressive turnaround times, is intensely customer-driven. To survive, labs must offer an efficient and modern experience for growers and extractors. This tutorial will demonstrate how a web-based labora- tory information management system (LIMS), purpose-built for the cannabis industry, can help labs meet these demands from one end of a typical workflow to the other. Service Requested through Customer-Facing Portal The Growers' Portal provides customers with a frictionless mechanism for preparing and submitting requests (Figure 1). Growers can enter details about their sample (Is it an ed- ible? A flower? A concentration?). They can specify which tests they require and on what timeline. Then, using a pre- configured built-in list of mandatory information, they can provide details like the METRC ID or the mass of each batch. (METRC is the cannabis inventory accounting soft- ware designed for government agencies regulating legalized marijuana.) The grower may also attach a photo, which can be reproduced on the final certificate of analysis (CoA) for marketing purposes. Growers can pause and reactivate this request process at any time, giving those who anticipate a large harvest the opportunity to work ahead. The Harvest Lot Menu Screen gives them access to all of their harvest lot requests at vari- ous stages of service, from new through historical (Figure 2). Request Reviewed and Next Steps Assigned through Interface Once the grower has submitted a request for service, the lab receives notification. Administrators and lab managers who want visibility over incoming and active requests can use a Request Navigator fea- ture. Instead of running a search on a specific sample, the navi- gator provides users with a bulk view of all activity and the option to drill down into the details of any particular request. Requests that are missing critical information or have problematic timelines are pushed back to the grower with notes; those with all necessary details are accepted. At this point, the LIMS prompts the first automated eSignature (eSig) event. At strategic intervals throughout the cannabis testing process (such as when accepting a request), the cannabis LIMS requires a password-protected eSig authorization be- fore proceeding. The eSig function is part of an end-to-end digitized chain of custody, which can be configured to contain as much or as little detail as required. This allows auditors or other inter- ested individuals to quickly and easily investigate who inter- acted with a sample, and at what point in the workflow, by following the eSig breadcrumb trail. LIMS Tracks Sample Collection and Monitors Test Preparation Methods and Materials Once a request is approved, the lab uses its LIMS to del- egate a sampler who collects the sample from the grower. Each collected sample is photographed and assigned a digi- tal barcode in the LIMS, replacing the error-prone tradition of manual tracking. At this stage, the LIMS interfaces with METRC to signal that a sample is undergoing testing; such integrations also contribute to a more efficient workflow be- tween grower, lab, and regulator. As technicians prepare the sample for testing, the LIMS works in the background to monitor the test-readying pro- cess. It can signal when a reagent's inventory is low, or when an instrument or an analyst requires recertification. Such automated oversight drives efficiencies in both small orga- nizations (by liberating a limited staff from time-consuming administrative duties) as well as high-throughput labs with multiple locations. Tests Conducted with Instrumentation Synced to the LIMS A cannabis LIMS is preconfigured to support industry- LabVantage's Web-Based Alternative Helps Labs Control Costs, Gain Eā€¢ciencies, and Strengthen Relationships Using a Purpose-Built Cannabis Lab Informatics System Drug Discovery Tutorial Figure 1. Inside the portal, growers can enter details about their sample, specify which tests they require, and establish a due date.

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