Supporting the COVID Fight
by Neal Salerno, President, Eurofins Lancaster Laboratories
Earlier this spring, global news of the pandemic cast a wave of uncertainties for our families and friends, communities, and businesses. It also brought a renewed sense of resiliency, adaptability, strength, and determination to eradicate this devastating virus. From the beginning, our laboratory network found ourselves in the midst of a race to help our clients develop numerous COVID-19 therapies and vaccines. And I can’t help but feeling a sense of pride, knowing that we are helping clients advance these products through the necessary approval process. With Eurofins BioPharma Product Testing’s capacity and breadth of capabilities covering all cGMP testing, we are supporting all modalities being deployed in this fight. Eurofins’ core business strategy and highly trained team have positioned us well to serve clients and combat COVID.
Our laboratory teams supporting coronavirus vaccine and therapy testing have experienced a record demand for services. This includes viral, mRNA, and proteins for a potential vaccine as well as the antibody cocktails and other immunotherapies for patient treatment. Services provided under these programs include: method development and validation, product release and stability, raw material testing, microbiology support of manufacturing and testing of product, extractables & leachables, and container testing.
With the demand for quality testing and data integrity on the continual rise, we have risen to the challenge by expanding testing services and new technologies while continuing to focus on quality. We have reacted swiftly to the need in the market place by increasing our staff by over 10% and investing heavily in equipment, consumables, and capacity. Knowing we will be in this fight for months to come, we are not letting up and will continue to service all our clients to ensure we help get lifesaving products safely to the people that need it. We have worked hard to keep our staff vigilant with the use of social distancing and recommended safety protocols. In spite of the new workplace challenges from COVID, we have enhanced and adapted our Training Program to broaden current staff leadership and technical knowledge, while still onboarding new employees with the same level of quality, ethics, safety, and IT security courses as pre-COVID. Covering 12 Core Training modules, extended also to new PSS staff, we offered new-role training to approximately 850 staff, all successfully completing more than 3,000 course tests. We also have an ongoing partnership with our local Harrisburg Community College offering a Leadership Training Certificate program, and 39 Group Leaders completed the program.
The real test of how we are doing is client satisfaction, which is rooted in audits. And through our terrific partnerships and flexibility with clients, we all figured out ways to stay engaged and keep these moving. We adapted our on-site audits to be virtual, including detailed photographs of the facility to replace the facility tour. This has helped ensure clients are able to keep QA records up-to-date and continue services, while staying safe. During a typical year, we average ~150 audits a year. From January through March 24, 2020, we hosted 30 onsite audits. Rising above the challenges, from March 24 to date, we have performed 70 virtual audits with 23 scheduled for the remainder of this year. We have performed virtual audits in just about every time zone, which at times can be challenging, but we are more than willing to make accommodations for our clients who are overseas. Overall, conducting 123 audits is a testament to the outstanding collaborative spirit we have with our clients and desire to put patient needs first.
As I reflect on the year, I also want to share additional company highlights and enhancements you may find of benefit to your testing programs:
Product Testing Lab Expansion in Lancaster, PA - During the most recent building expansion at our Lancaster facility, we designed a new, 9,000 ft2 Product Testing Laboratory space with LEAN and 5S initiatives to increase efficiencies, expedite chemists’ time, and maximize equipment usage to better serve clients.
Category 5 Labs - We have built lab suites to accommodate highly potent/toxic samples, or samples with a Category 5 payload, at our Lancaster, PA, and Columbia, MO, sites.
Micro Lab at Portage, MI - Our Portage lab has expanded the microbiology lab, including the ability to handle BSL2 samples and a new offering of Antimicrobial Effectiveness Testing.
BSL2 at Columbia and San Diego - Our Columbia, MO, and San Diego, CA, labs have upgraded biochemistry labs to BSL2 to allow for containment and handling of additional sample types and hazard levels.
Sterile Fill/Finish -Our lab in San Diego, CA, is now offering Sterile Fill/Finish services to small batches of sterile GMP product for Phase 1 and 2 trials.
Rapid Sterility - With faster sterility detection, we are able to help clients reduce the financial and operational impact of a contamination event by initiating investigations and corrective action early in the process.
Surgical Mask Testing - We adapted our labs to support surgical mask testing to meet requirements for FDA Enforcement Policy for Face Masks and Respirators.
Viral Clearance SL 2/3 - Our Full Service and Turnkey Service models of viral clearance testing allow clients to stay safely at their sites while Eurofins performs the necessary steps.
LabAccess - We upgraded functionality of our data portal, LabAccess.com, to include quotation documents, PO documents and tracking, as well as a new interface to make navigation easier.
Data Integrity - We have continued our investments in data integrity and management to achieve safety of data and better efficiency.
We all look forward to a brighter 2021, and next year, we celebrate our 60th anniversary. Our business has achieved a phenomenal trajectory of accomplishments decade after decade and forged long lasting relationships with many wonderful clients. While these past 60 years have not been without its challenges, a few things remains consistent: our commitment to quality, our people, and helping our clients succeed. I look forward to all the great things we’ll achieve together next year. And I wish you and your friends and family the very best holiday season and happy and healthy New Year.