In this IssueThe value in a

trusted partnership 2 Cell and Gene Therapies take

industry by storm 3EBPT Portage expands Micro

capabilities 4Investing in Data Integrity

Compliance 5 Best data access portal just got

better with LabAccess 4.0 6BPT Columbia expands cGMP

Radiolabeling Labs 6People are the Chemistry 7

Bio/Pharmaceutical NEWS Sp

ring

2020

Bio/Pharmaceutical NEWS 2 Spring 2020

Neal Salerno, President, Eurofins Lancaster Laboratories

The value in a trusted partnership

Never in our lifetimes has the word partner had more significance than during this COVID-19 pandemic. From the beginning we partnered with our amazing staff to keep them safe by encouraging work flexibility and safety protocol adher-ence through social distancing and good hygiene. We partnered with clients by working closely to remain flexible as project prioritization changed and adapted schedules to help advance life-saving medi-cal devices, drugs and vaccines to patients and medical staff in need. Across the globe we’ve partnered with all Eurofins sites, BioPharma-ceutical companies, Governments, and non-profit organizations to help put an end to this crisis. Through these partnerships we have been able to keep our coworkers safe and maintain business continuity to sup-port all the vital working happening in our industry.

For the BioPharm industry, our work truly is essential. Trusted for our decades of scientific exper-tise, vast range of capabilities, and

driven work ethic, Eurofins BioPhar-ma Product Testing stands together with clients in working non-stop to provide COVID-19 testing support wherever needed.

Behind the testing are our teams who have showed great flexibility and perseverance to help support clients’ COVID-19 therapeutic ad-vancements. Many have changed or adjusted shifts with no overlap to maintain segregation, worked overtime and on weekends to meet clients’ TATs, offered expertise in exceptionally busy departments when needed, as well as work remotely where possible. We’ve al-ways known that our people are our greatest asset, and they continually show their dedication during times like these. I’m extremely humbled and proud to work with such a great team.

With the race to deliver life-saving therapies and safe medical de-vices to patients and medical staff, Eurofins BioPharma Product Testing teams are providing clients with reg-ulatory compliant data and expe-dited COVID-19 testing support for all drug modalities and parts of the supply chain, including Antivirals, Vaccines, mAbs, Antibodies, RNA, and Testing Kits, with expertise in:

• Raw Materials Testing • Product Testing • Viral Testing • Microbiology• Cell Banking • Cell and Molecular Testing• Stability and Release Testing

and Method Development • Medical Device Testing and

Method DevelopmentWhile the world’s focus is on the eradication of COVID-19, other diseases simply have not taken a time-out. Whether it is helping sup-ply medicine for cancer, HIV, heart

disease, or other health issues our employees continue to take pride and remain vigilant in helping cli-ents battle these maladies and get essential medicines to the patients who need it.

Further, to ensure we meet the BioPharma industry’s high demand for expanded and expedited test-ing support of all drug modalities, we continually invest in our people, systems and facility as we’ve done for the last nearly 70 years. To accommodate clients’ ever-chang-ing and increasing needs and flex our adaptability, every day we continue to:

• Purchase state-of-the-art instru-mentation

• Hire experienced scientists and support staff

• Require employee training and encourage career development with new program offerings

• Invest in IT infrastructure and security to guard data integrity along with extensive capital and labor to increase technological controls (See page 5 for more details.)

• Improve Safety initiatives and training

• Expand and enhance facility and laboratory spaces, implement-ing Lean designs for improved efficiencies

From a business standpoint, we are fortunate to be in a good place to weather this storm and have such a phenomenal team and clients fight-ing the good fight.

More than ever before, we continue our mission and partnership with our clients to help make the world healthier and safer.

This pandemic will end. Life will return to normal. Until then, I hope you and your family stay healthy.

Bio/Pharmaceutical NEWS 3 Spring 2020

Marian McKee, PhD, Vice President, BioSafety; Berangere Tissot, PhD, Di-rector, Biochem Method Establishment & Biologics CharacterizationThere is no doubt that emerging new cell and gene therapies have taken the industry by storm. As a CRO, we have a unique perspective on this trend. Where we once saw small biotech popping up in various phases of development in this field, we now see big-pharma stepping in with all their influence. The M&A of these biotechs as well as the creation of new cell therapy divisions in big-pharma have led to a plethora of clinical phase programs. Each of these companies has faced a relatively uncertain analytical and regulatory obstacle.

Viral vectors used for gene and cell therapy as well as the raw materials used to manufacture these advanced therapies are all subject to testing either for quality control or characterization to insure product quality and performance. Manufacturing process consistency is mainly controlled by (1) raw material and reagent qualification programs, (2) in-process monitoring, (3) in-process control testing, (4) lot release tests, (5) traceability by using a chain-of-identity system, and (6) validation of the manu-facturing process.

The regulatory agencies have all ad-dressed these therapies at one level or another. In January 2020, the FDA published Guidance for Industry on the CMC for Human Gene Therapy IND. In this document, the FDA made clear that it “generally considers human gene therapy products to include all products that mediate their effects by transcrip-tion or translation of transferred genetic material or by specifically altering host (human) genetic sequences. Some examples of gene therapy products include nucleic acids (e.g., plasmids, in

Cell and Gene Therapies take industry by stormvitro transcribed ribo-nucleic acid (RNA)), genetically modified microorganisms (e.g., viruses, bacteria, fungi), engineered site-specific nucleases

used for human genome editing (Ref. 2), and ex vivo genetically modified hu-man cells.” This includes the viral vec-tors and the resulting CAR-T therapies. The agency also provided guidance for specific disorders, rare diseases, and testing for vector-specific safety con-cerns. Additional guidance is available in the USP including chapters <1046> Cell-Based Advanced Therapies and Tissue-Based Products which has been revised effective May 2020. Together with <1047> Gene Therapy Products and <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products, the USP includes guidance and com-pendial methods to address raw material and the cell therapy product testing.

Within the Advanced Therapy space, Eurofins has a history of offering cGMP-compliant CMC testing to ensure the identity, potency, purity, and safety of starting materials, intermediate prod-ucts, vectors, and final drug products as well as support for manufacturing process development and validation. This includes testing of raw materials, cell and viral bank ser-vices, plasmid vector testing, lot release testing, and bulk and finished product testing. Within the Biopharma Biolog-ics Testing group

we have recently added analytical ultracentrifugation to support regulatory expectations around empty/full capsid analysis. Eurofins has also invested in technology to allow rapid sterility testing requirements for autologous cell thera-pies and digital droplet PCR for more precise quantitation of viral particles. Investments in Eurofins BioPharma Product Testing facilities expand CGT capabilities, and include laboratories be-ing updated to accommodate biosafety level-2 (BSL2) work, to maximize space utilization, and to optimize workflows.

Read more from Dr. Marian McKee on Cell & Gene Therapy in the May issue of BioProcess International: https://bioprocessintl.com/bioprocess-insider/therapeutic-class/want-to-keep-up-with-demand-for-cgt-testing-stay-nim-ble-and-invest-says-eurofins/.

Bio/Pharmaceutical NEWS 4 Spring 2020

Jennifer Foote, Manager of Microbiology and Site Operations; Nathan Whitford, Site Director; Eu-rofins BioPharma Product Testing, Portage, MIAs the Eurofins Lancaster Labora-tories site in Por-tage, MI, continues to grow, the micro-biology team has been no exception. With a focus on non-sterile product testing, the team has continued to grow and add testing capabilities to complement the drug substance and finished product testing supported by the site.

The site’s controlled access microbiol-ogy laboratory is equipped with a vali-dated sterilizer and six biological safety cabinets capable of handling BSL2 materials. This has enabled the team to develop routine partnerships to provide microbiological services that include bioburden, growth promo-tion, microbial limits, water activity, environmental monitoring, and pro-cess water testing. With this testing, the Portage microbiology team has steadily built a reputation for con-sistently achieving client turnaround times, including rush requests, with no less than 93% of testing meeting turnaround time for the last two years. This turnaround time accomplish-ment has been enabled by imple-menting systems related to a LEAN laboratory design and improved docu-mentation. Included in this process is the use of documentation processes in electronic laboratory notebooks (ELN) that continue to be expanded across all current microbiology service offerings. The use of ELN allows for maximizing testing efficiency while reducing errors related to documentation. Additionally, this allows for reduced review times and flexibility with the staff to accommodate a variety of schedules.

EBPT Portage enhances and expands Microbiology capabilities portfolio; continuous collaboration with Lancaster Micro serves clients well

As part of our efforts toward continual improvement, new LEAN initiatives have been implemented to streamline data review practices and restructure the organization and process flow of media production. With the recent addition of the site’s first LEAN industrial engineer, we will be selectively identifying further areas for improvement through process

mapping and appraisal of our micro laboratory practices.

As the team in Portage has continued to grow, additional testing capabilities are being added currently and in the future. Most recently, the team has added Antimicrobial Effectiveness Testing (AET) for non-sterile products. With this addition, the team continues to focus on professional development of the growing

staff. This allows for the expansion of techni-cal skills at both the scientist and leader-ship levels so the team can continue to ensure members are current in microbiology service of-ferings and maintaining awareness to industry trends.

As a smaller laboratory site, the Portage team has been known to col-laboratively partner with the technical leader-ship within our client’s teams. This technical collaboration has proven to be very beneficial in onboarding new project work, interpreting client

testing needs, and providing responsive investigation updates. It also allows for flexibility when rush requests have been submitted so that client requirements and turnaround time has consistently been met. Clients have shared their ap-preciation of the access to the technical resources the site provides on the road

toward meeting their requirements.

As the Eurofins Lancaster Laboratories, Inc. site and microbiology department continue to grow and expand on testing capabilities, we invite all of our current and new clients to evaluate this location for their testing needs. The team in Por-tage is excited for the new opportunities and challenges that will come as the site continues to grow.

Bio/Pharmaceutical NEWS 5 Spring 2020

Investing in Data Integrity Compliance: A holistic look at Euro-fins Lancaster Laboratories investment in data managementTravis L. Emig, Vice President, Bio-Pharma Chemistry, Eurofins Lancaster LaboratoriesOver the past several years there has been an intense regulatory push on the Pharmaceutical Industry to ad-dress potential gaps with data integrity, software validation, system integration, and information management. Estab-lished guidance from various agencies and sources, including FDA, MHRA, ALCOA, continues to evolve in an effort to prevent fraud and build confidence in data security, accuracy, recoverability, and overall risk management.

Eurofins places the highest value on data integrity. We recognize how critical this topic is for quality and establishing client trust. Eurofins has evaluated ev-ery legacy system we utilize (comprising some 245 instruments and 100 different versions of application software) in an effort to enhance data integrity pro-grams. A Failure Mode Effects Analysis (FMEA) style assessment of quality systems, technical and procedural controls of those systems was performed based on risk. The FMEA employed all of the applicable aspects of 21CFR part 11, Annex 11 and current FDA and MHRA guidelines on data integrity. This analysis effort, and the resulting report (Gap Analysis), are used to assess each individual software/version. The results were used to create an individualized software risk mitigation strategy.

Policies and procedural controls were enhanced to remediate some individual legacy laboratory data systems. With other systems, more time consuming, as well as costly, implementation of tech-nological controls for remediating data integrity gaps was preferred.

Additionally, procedures for initial valida-tion and change control were updated to ensure any new systems were assessed and remediated, prior to being allowed into production for GXP testing.

In addition to the extensive Eurofins Global IT investment in infrastructure and security, Eurofins Lancaster Labo-ratories (ELLI) has invested extensive capital and labor to increase technologi-cal controls, as showcased below:• Implementation of a 3rd party enterprise software to monitor and prevent data deletion from all compatible “flat file” based systems. Monitoring over 60 stand-alone laboratory instruments currently, with unlimited capac-

ity for future system additions.• Establish internal reporting tools used in conjunction with the 3rd party enterprise software. These compile deletion monitoring results from all systems into a single report, assessed daily by QA. • Software upgrades and re-validation to al-low for data security, audit trail accessibility, and enhanced user access controls. • Installation of Waters NuGenesis LMS and OpenLab as data management resources in conjunction with Waters Empower 3 Chromatography Data System and Chemsta-tion respectively. NuGenesis LMS allows for automated archiving of Empower 3 project data. • Purchase, validation and implementation of 3rd party, fully electronic, validation lifecycle documentation and tracking software. • Windows operating system upgrades al-lowing data systems to remain current with updated vendor software assuring overall system security• Upgrading stand-alone software technology to enterprise level systems that inherently uti-lize database technologies restricting unwar-ranted data deletion, increasing remote data review ability, without inhibiting ongoing data acquisition and sample data throughput.• Upgrades to existing, stand alone, analyti-cal instrumentation software allowing for use of unique log-ins for secondary quality review of audit trails, data and metadata without inhibiting ongoing data acquisition.• Electronic Notebook integration with instru-ments for direct data capture.

Subsequent to upgrades and enhance-ments, the requirements of data re-view staff have changed dramatically. Migrating to electronic record review processes has required purchasing of li-censes for user accounts, administration of specific system data review training, and regulatory education on audit trail review and orphan data assessment. This equates to a significant increase in labor needed to perform the data review. Eurofins strives to find efficiencies in any system, be it software, LIMS, Electronic Notebook, etc., however efficiency gains made do not offset the increased labor needed to now perform data review in a fully electronic world.

Bullet points are provided to demon-strate the key objectives in our quality review program.

Legacy Eurofins Practices (High Qual-ity baseline)• Laboratory Ethics and Data Integrity Policy/Training

• Full utilization of electronic notebooks for documentation and data capture• Zero tolerance position for illegal, unethi-cal, or improper practices affecting the test-ing and reporting process• Review of audit trails at the time of release for high volume/high risk systems.• Periodic traceability audits by QA

What Eurofins has implemented• Review of audit trails at the time of release for additional systems• Periodic audit trail review of systems • Robust backup/restore process + periodic QA check• Balance/ ELN integration • Conservative process on evaluating invalid and system suitability failure runs• Conservative view of evaluating changes to raw data• Improved Cyber security

What Eurofins is planning• Integration of other instruments with ELN• Enhancing disaster recovery procedures• Implementation of additional , efficient, electronic notebook recipes and templates• Implementation of digital signatures

Estimations on the investment levels are provided for reference. This was necessary for ELLI to achieve an indus-try leader position in the area of data integrity and management.

Capital expenditures: $1.5M USD

Direct Labor Headcount (Quality Engi-neering, Quality Assurance, Electronic Notebook, Systems Administration Specialists): 12 additional Staff

Indirect labor headcount (Data review, Validation Specialist): 25% increase over 2 years.

Throughout these efforts in addressing the current expectations for data and software management, ELLI has kept focus on achieving efficiency with tools and processes to control the overall cost to our business. However the costs sim-ply exceed what can be gained through efficiency. ELLI pricing has reflected this added operation cost. However, customers can be confident that Euro-fins is exceeding expectations in data integrity compliance.

Bio/Pharmaceutical NEWS 6 Spring 2020

Harley Wilcox, Senior Scientific AdvisorRadio labeling of drugs continues to be essential in support of ADME studies for pharmaceuticals in development. Radiolabels allow for efficient monitoring of absorption and metabolic profiles via specific mass or radioactive detection. Eurofins BioPharma Product Testing Columbia’s cGMP synthesis facility have been providing labeling and other syn-thesis offering for over 20 years. Based in Missouri, the current synthesis staff has on average more than 10 years of experience.

Due to continued and higher request for radio synthesis, a recent expansion of these specialized laboratories has been completed. Three new labora-tory hoods and laboratory updates will allow for higher capacity and more efficient services. The laboratory offers four cGMP suites. The facilities primary service offering centers on stable and radio-labeled compounds to support GLP, cGMP and non-regulated projects. Other small scale synthesis projects may

Daniel D Agostino, Principal Specialist, Bio/Pharmaceutical Project Manage-ment; Cristi Morgan, Manager Process Engineering & Strategic ProjectsLabAccess has set Eurofins’ Lancaster Laboratories apart from other contract laboratories by securely giving clients direct 24/7 access to their Certificate of Analyses and Raw Data in real-time for over 10 years. And since all Eurofins BioPharma Product Testing global labo-ratories are now on the same eLIMS-BPT system, all laboratories within the network can now use LabAccess for clients.

Eurofins has been busy upgrading the functionality of LabAccess, and in December 2019, LabAccess 4.0 was released. As part of this release, the fol-lowing items can be accessed:

1) Quotationsa. eLIMS-BPT quotation documents

Industry’s best data access portal just got better with LabAccess 4.0are available to view or download

2) Purchase Ordersa. Purchase Orders managed in eLIMS-BPT are available to view or download

b. The module also allows tracking of the fund availability on a real-time basis

3) Investigations (Exceptions)a. eLIMS-BPT closed Exceptions (i.e. Exceptions that begin with “EXC”) are available to view or download

b. This module also allows users to sort by certain information such as initiating event

4) Eurofins’ global brand harmonization

a. New LabAccess logo

b. Updated user interface

5) Increased harmonization with eLIMS-BPT6) Availability of effective docu-ments from the eLIMS-BPT systemWith this additional information readily accessible, it is our goal to streamline the management of your activities with Eurofins BPT. Please note that gaining visibility to these additional features may require that additional permissions are added to your LabAccess user account.

Please contact your Client Service Representative for additional informa-tion if you are interested in exploring this feature. Or simply get started by visiting: www.eurofins.com/biopharma-services/product-testing/resources/labaccess-com/quick-start-guide/

Eurofins BPT Columbia Expands cGMP Radiolabeling Labsbe considered. Carbon 14 continues to be a primary request along with stable labels incorporating deute-rium, 13C and 15N.

Analytical support in addi-tion to GLP and cGMP CoA release testing includes:

• Full stability support

• NMR

• Chiral analysis

• Assay and impurity analysis

• Residual solvents

• Radio purity

• Release testing

• Protocol driven phase appropriate method transfers and validations

Eurofins BPT looks forward to support-ing your isotopic labeling needs and is pleased to offer technical consultation to aide in synthesis routes and position labeling.

Contact us at pharma@eurofins.com for your radio synthesis needs.

Click here for more information or to request a quote.

Bio/Pharmaceutical NEWS 7 Spring 2020

At Eurofins Bio-Pharma Product Testing, we believe that our people pro-vide our strength. Their dedication to quality, profes-sional competence and hard work are the key elements in the company’s success. In this regular feature, we introduce you to some of the people who have helped make Eurofins an industry leader.

People Are our Chemistry

Bringing more than 20 years of biosafe-ty industry, testing, and R&D experi-ence to her role at Eurofins Lancaster Labs, Dr. Marian McKee, espouses an appreciation for the significance of the work clients do for patients in need and the value Eurofins’ testing support delivers. “Biosafety is such a critical step in drug development that our cli-ents must complete to ensure therapies are safe for patients,” says Marian, Vice President, BioSafety (Viral Clearance, Viral Safety, Cell Banking). “It’s gratify-ing that my team and our broad array of testing services help perpetuate the pipeline and have such a vital role in getting medicines to patients.”

Relatively new to Eurofins, joining in 2019, Marian brings both a fresh and sage perspective to the leadership team, noting the importance of the Lab’s diverse staff with many long-term employees peppered throughout with new staff to meet growing needs. “Hav-ing spent a decade at a competitor lab, I was fully cognizant of Lancaster’s stel-lar reputation and strong client loyalty,” says Marian. “So when I was recruited to interview, my curiosity peaked. Upon arrival I was pleased to find a beautiful state-of-the-art campus, conscientious corporate culture, talented employees, and a growing business with room for personal career growth.”

Marian earned a PhD in microbiology and immunology at Uniformed Service

University of the Health Sciences in Bethesda, MD, and completed her post-doctoral work at the National Can-cer Institute at NIH.

What does your current job entail?

As Vice President of Biosafety, I provide guidance and the long range planning for Viral Clearance, Cell Banking, and Viral Safety testing groups, including development and strategic insight into the company’s biosafety offering includ-ing our gene and cell therapy or ATMP testing offering.

What is the scope of your group?

Members of my team provide the sci-entific and technical expertise to insure that our client’s biopharmaceutical products are free of viral contaminants. They include the Viral Clearance team who perform studies to demonstrate that our clients’ purification processes are effective at removing viruses during the purification process, and the viral safety testing team who test biologics, including ATMPs to assure that these

products are free of viral contaminants.

We also provide cell banking services which insures that one of the most criti-cal raw materials for biologics is secure and well character-ized. Members of the Cell Banking depart-ment provide mam-malian and insect cell banking services to GMP standards for production, R&D, and bioassay banks. The department also pro-vides cell expansion services in support of cell line characteriza-tion testing.

What kind of volun-teer activities have you been involved with?

I really enjoy bringing science and STEM education to others

and have been doing so since my post doc days at NCI where I was on the NIH Speakers Bureau. I have found a number of ways to do this over the years through corporate outreach programs and through serving on the board for two nonprofit foundations, STEM for Her and STEMs Grow. With STEM for Her, I was able to share my experiences as a woman in science and mentor young women in high school who are interested in STEM careers. I look forward to continuing to share my passion for science here as well.

And when you’re not working?

When I am not working, you’ll find try-ing a new recipe for dinner or cocktails, spending time with my family, at a Washington Nationals baseball game, or exploring the local area. I love to travel and explore new places. With my three children all living in different places (Chicago, Charleston, SC, and Blacksburg, VA), my husband, Charles and I get the chance to spend time with them and explore at the same time.

Dr. Marian McKee with husband Chas

Avoid thinking strictly inside the box and learn from our webinar on Bio/Pharmaceutical Package Testing

On May 26, 2020, virtual at-tendees connected with Euro-fins dur-ing its live webinar to help clients trouble-shoot and solve their package

testing challenges. Sunny Modi, Ph.D., Director, Eurofins Medical Device Package Testing, shared how focusing on product packag-ing can help save avoid delays in product development.

Webinar Overview:Companies are often so keenly focused on developing the product inside the box that they can some-times miss critical requirements for the package that is intended to protect it. Designing safe packag-ing that will protect products dur-ing shipping and transport, while simultaneously complying with FDA or international health and safety regulations is essential. Developing an appropriate test plan for package performance testing is of utmost

importance with the globalization of the bio/pharmaceutical industry.

During this webinar, Eurofins shared insights and test plans to demon-strate how focusing on the packag-ing for your product can help to save you time and avoid delays in your product development, includ-ing:

• Answers to common packaging questions • Overview of various testing standards required to get your

product to market • Testing to consider for various shipping methods and tech-niques • The current status and expec-tations of the FDA • How to design a test plan to meet the supply chain rigors

Discover how Eurofins can solve your Package Testing challenges.

CLICK HERE TO VIEW FOR FREE

Contact usFor information on services, literature re-quests or address changes, please contact: Bio/Pharmaceutical Business Development, 717-656-2300, pha@eurofinsus.com, or visit www.eurofinsus.com/bptBio/Pharmaceutical NEWS is published for clients, employees and associates of Eurofins BioPharma Product Testing US. Editor: Lisa Bamford, LisaBamford@EurofinsUS.com