The Operations team is excited to share their ongoing projects as they continue to support and enable the growth of LGC CDx in the US and globally.
The past quarter has been an exciting one in the world of Environmental Health and Safety. The team has focused on standardizing, harmonizing, and simplifying the EH&S program, with emphasis on the following key areas:
Compliance: To ensure the compliance of all U.S. sites, we continue to harmonize EH&S procedures for consistent practices.
Reporting: We re-launched the Near-Miss Program (Document # CFORM1000.06-02) to enable proactive risk mitigation and reduce OSHA 300 reportable incidents. Report any near misses to CDx.NearMiss@LGCGroup.com.
Training: HAZWOPER training was provided to all sites where needed. A big thank you to Virginia Cody, Aya McGonagle, Patrick Irish, Anh Nguyen, Joe Paglio, John Carthy, Majdi Hamouda, Kinh Hann, Matthew Butler, Czezre Adams, Tonya Watkins, Dave Hardy, Rob Frechette, Ashley Ryan, Chad Minnette, Elizabeth Smith, Ashley Nobrega, Kiet Hong, and Mike Welsh, who participated in this training to support our commitment to safety.
U.S. Site Expansion Updates
As operations and business continue to grow in the Gaithersburg, MD area, the team has been working with external and internal stakeholders to support the growth of the facility. In early November, we signed a lease for additional space to support this growth. More work is underway to finalize the design, fit-out, and expansion efforts. Phase 1 will be the creation of two new viral labs along with seating space for 6-8 people. The new viral lab will increase production and development capacity to meet current and future demand. Additional seating space is critical as our current space is at capacity.
Growth within the Maine site continues to increase. To enable that growth, we are designing an expanded site that supports current and mid-term growth needs and addresses a number of operational inefficiencies and facilities risks. To date, the team has concept design drawings and has begun site survey and geotech work in preparation for more detailed design work to proceed throughout the winter months.
SAP Phase II Go-live and the birth of LGC CDx Inc.
Over the past few months, teams from our legacy Maine Standards and SeraCare Life Sciences businesses have been working to consolidate their North American legal entity structure and unify our Enterprise Resource Planning system in the U.S.
On Friday, 1 October, this cross-functional effort culminated with the go-live of SAP at the Maine site. SeraCare Life Sciences, Inc. and Maine Standards Company LLC officially becoming LGC Clinical Diagnostics, Inc., retiring legacy legal entity names.
By standardizing their ERP footprint and legally unifying their businesses across the U.S., LGC CDx has been able to retain the brand and product value of both SeraCare and Maine Standards, while optimizing operational delivery.
This transformation effort supports our continued growth and improves our ability to unlock valuable opportunities to meet our customers’ needs and expectations.
Project Management Office (CDx PMO) establishment
In September of 2021, LGC CDx established a Project Management Office to transform its approach to key initiatives and major cross-functional projects to enhance the value and efficiency of delivery. The PMO has established a new approach to project management across CDx, supported prioritization efforts for the business, and helped to coordinate, synchronize, and facilitate project deliveries.
Better together
LGC CDx U.S. Operations and TCD Ireland Operations continue to design, construct, and implement unified global methods that support our customers and the growth and scalability of our business. Our ability to quickly identify, plan, and engage opportunities as one global team is evident in the ACCURUN®/Multichem ID Bulk Serology project. In this instance, a time sensitive, high revenue potential opportunity was identified, the U.S. CDx and TCD Ops teams came together in partnership with our Commercial team and were able to provide a rapid plan to solve one of our key customer’s supply chain issues. While this project is still in the early stages, it is an example of our valuable collaboration.
Well done!
Kudos to both Ganesan Venkatesan and Tracy Lombardi for their perseverance in sourcing containers used for pooling and sampling plasma. A customer recently began ordering a finished goods product that was previously discontinued. To manufacture this product, special containers for the sampling/pooling of recommended plasma units are required. Locating a suitable replacement for a recently discontinued two-gallon container proved to be extremely problematic. Either the opening size on the container was too small, the price prohibitive, the required purchase quantity prohibitive, or the lead time well beyond our required date. After an exhaustive search of potential replacements and a careful review of product COAs and literature, a suitable replacement was recommended and approved by the customer, allowing us to not only accept a large order, but also giving us the flexibility to continue to make this product in the future.
Technopath Operations
In November 2021, Technopath Clinical Diagnostics had its largest filling month ever. Approximately 950k vials were filled throughout several fill events and across multiple different product types. The longest fill event for TCD was also recorded in November, spanning over a 40 hour period.
TCD also recently implemented active shipment for Multichem U to Abbott, with waste elimination and cost reduction opportunities realized. Additionally, validation has been completed for a new filling machine for Radiometer and serology products, and a new diafiltration system has been implemented in manufacturing.
Site expansion is also on the horizon for Technopath, with the expansion proposal currently progressing through the feasibility phase.
TNAC Operations
A new facility shell has been under construction at The Native Antigen Company. It progressed well in the last quarter, with completion expected at the end of January 2021.
 |
 |
Above: Facility shell construction
The fit out of the facility into labs and offices will occur in the first 4 months of 2022, with move-in tentatively scheduled for May of 2022.
With the purchase of a single cell cloner, TNAC has begun constructing stable cell lines to increase the yield of several difficult antigens. The use of this technology is expected to double or even triple the yield.
API Operations
The API team have almost wrapped up their first year managing the newly expanded AXIO Clinical Laboratory Scheme (CLS) PT program from Traverse City. They have passed a 1-year surveillance audit to retain ISO/IEC 17043 accreditation for the program.
Finally, huge congratulations to Ryan Raftery and his wife Grace on the birth of their third child, Henry Richard Raftery.
