NEWS. Bio/Pharmaceutical. Few things in life are absolutely free Except our viral clearance guarantee. Winter 2016.

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1 Bio/Pharmaceutical NEWS Winter 2016 Few things in life are absolutely free... In This Issue It s About the Science page 2 Quality Metrics can help reduce FDA audits page 3 Electronic Notebooks page 5 FTE locks in dedicated staff for each client page 6...Except our viral clearance guarantee. Giving you unbridled freedom to chase your wildest viral clearance goals, we guarantee they ll be met or we repeat the study for FREE. More on page 4.

2 It s About the Science by Timothy S. Oostdyk, Ph.D., President, Eurofins Lancaster Laboratories; Sr. Vice President, Eurofins BioPharma Product Testing Group In 2015, I marked my 30th year with Eurofins Lancaster Laboratories. It s been a great 30 years, and I continue to enjoy every aspect of serving our customers and growing our business. As I think about the evolution of our business over those years, one aspect that stands out to me is the transition from just being great at executing our clients laboratory methods, to being a key partner in enhancing and developing their science-all to help meet their goal of bringing better solutions to patients. Outstanding execution every day is still absolutely critical to being a great contract services provider, and it always will be, but today more than ever our customers expect and need great science as well. Delivering great science can only be achieved with talented and committed scientists. As we ve grown significantly over the years, our talented people have consistently been at the core of our successful client relationships, working long hours for complex projects, tackling advanced training and graduate degrees, and pursuing groundbreaking developments to deliver more successful scientific outcomes. Our people and company culture espouse a spirit of continual learning and improvement. One way we achieve this is through comprehensive training and development. To support our employee education initiatives and to address ongoing staff growth, in 2015 we tripled the size of our dedicated Training Facility to more than 6,000 square feet. In addition to a large laboratory module for hands-on exercises, this new expansion houses several conference and computer classrooms with seating for up to 50 people, as well as space to bring in strategic vendors for specific high-level training on new and advanced technologies. As we continue to build our talented team, approximately 350 of our US based BioPharma Team now hold a Ph.D. or Master s degree. And we have a lot of exciting scientific developments being pursued, with some examples presented below: Our Biochemistry Team is active in many different areas of development, including the following: Research on biosimilars was recently presented at CASSS MS in Brooklyn Studies performed on Intact Mass Analysis and light/heavy chain and three-part subunit analysis using the Fabricator enzyme Investigation in heat-accelerated stress on Adalimumab and attempting to identify acid and base degradants observed in Imaged Capillary Isoelectric Focusing (icief) and Capillary Electrophoresis (CE) experiments, using peptide mapping, intact mass analysis, and ion exchange chromatography Peptide mapping experiments on Adalimumab and Avastin to demonstrate sequence coverage, sequence variance, disulfide mapping, and post translational modifications Involvement in a NIST collaborative Glycan study of a reference monoclonal antibody Performing experiments on a MALDI TOF/TOF MS to investigate N-Linked glycans using a simpler and more rapid approach The goal of all of these studies is to gain an understanding of the structure, develop platform methods, and generate data that can be presented to potential clients. Our Extractables and Leachables Team is investigating accelerated verses real-time aging of bioprocess bag films to determine if accelerated aging is an accurate prediction of real-time leachables profiles. These studies will help us as we guide our clients and develop protocols that yield accurate information about disposables and other materials. Our Cell and Molecular Biology Services Team has a proven track record in successfully developing and executing qpcr, ELISA and cell based potency assays intended for product release, characterization, and stability studies. Our success in these areas is due to the efforts of our team of expert scientists as well as a rigorous training program, and this team has now grown to more than 80 people housed in our Lancaster and Munich sites. Recently the department in Lancaster established a dedicated Assay Development Team consisting of Ph.D. scientists with extensive knowledge and hands-on experience in cell line engineering, biopharmaceutical product development, cellular signal transduction pathways, protein structure-function analysis, and state-ofthe-art molecular techniques. The Assay Development Team is responsible for developing ready-to-use assays, such as the array of release and characterization assays for biosimilar products. They also provide technical consultation to assist with the optimization of challenging client methods. Importantly, the team has been tasked with identifying and anticipating industry scientific and regulatory trends and expectations to ensure that the department remains cutting edge. Behind all this exciting science are many talented and motivated scientists. With our employee turnover at half the typical industry rate, investing long-term in our people enables us to provide our clients with both great execution and great science. And in today s ever evolving marketplace, this is clearly what it takes to be a strategic partner with the aspiration and objective of supporting and enhancing our clients effectiveness in bringing better solutions to patients. Bio/Pharmaceutical NEWS 2 Winter 2016

3 FDA guidance requires comprehensive, consistent contractor management Eurofins Lancaster Labs Quality Metrics program can help clients reduce FDA audits The FDA recently issued a new guidance to the bio/pharmaceutical industry regarding contractor management, which detailed that manufacturers are ultimately responsible for all operations of the supply chain, including contract vendors. The agency is seeking to have efficient, flexible and compliant firms without extensive regulatory oversight by developing meaningful quality metrics, not just for the firm itself, but for all involved supply chain partners. In order to meet the desired state required by FDA, firms must establish an effective quality system through implementation of a strong quality culture and proactive management. Companies that abide by this guidance and successfully present quality metrics to the FDA would potentially be considered low risk, thus decreasing the frequency of required audits by the FDA. Eurofins Lancaster Laboratories has taken proactive measures to help our clients meet this requirement with the development of our Quality Metrics Report. The report serves as a score OOS OOA/OOT/NRR Unplanned Deviation Client Request/Complaint Operator Related Errors Product Related Lab Contamination Tests # Tests w/ OOS % OOS # Tests w/ OOA/OOT/NRR % OOA/OOT/NRR # Tests w/ UD % UD # Tests w/ CRR % CRR Tests w/ ORE & ORE Tests w/ PR % PR Tests w/ LC % LC Total # # On Time % On Time card to measure key quality and operational indicators throughout a client s project with us. All reports are available on our online data access portal, LabAccess.com SM where clients will also find a history of all previously saved reports to provide access to this important, historic information with the click of a button. We will also provide supporting documentation along with the report when needed. Among the first laboratories to offer this report in response to the FDA s new guidelines, we maintain a strong regulatory profile through successful inspections by the most prominent domestic and international authorities, such as FDA, EMA and DEA. With a ratio of one quality staff member for every 10 technical staff members, our vast quality unit is able to sufficiently monitor our laboratory operations and procedures. Type of Data Reported While the report can be fully customized to meet individual needs, Q Q Q Q our standard metrics report includes key operational and quality indicators, such as: Total on-time release of test Out-of-specification (OOS) Out-of-trend (OOT) Non-representative result (NRR) Unplanned deviation Client requests or complaints Product related sample group Lab contaminated sample group Types of Reports Project-specific report - shows data for a specific project Client report - shows data for any or all projects for the client Location or site-specific report - shows data for any or all projects from a particular client site Frequency of Reports The reports are automatically generated on a quarterly basis, but can also be performed for any defined time period per the client s request. We can also provide retroactive reporting, as needed, to show up to three years of historical data. Format of Reports We provide the Quality Metrics Report in a spreadsheet format as shown here at left; however, we can also generate pivot tables (as shown above) for any of the quality indicators to allow you to identify common trends, understand the correlation between your data elements and further analyze your metrics. Bio/Pharmaceutical NEWS 3 Winter 2016

4 Clients rave about our viral clearance services and guarantee Your team s expert assistance, execution, and turnaround times far exceeded my expectations for our viral clearance study. - Scientist in Downstream Bioprocessing, Manufacturing and Technology, Mid-Size Biopharm Company Great group to work with. Lots of experience in viral safety validation, super insight into what the regulators expect and excellent sanity check for experimental design and strategy documentation. We plan to work with Eurofins Lancaster Labs to compile our complete viral safety package. - Vice President and Ph.D., Process Development, Mid-Sized Biopharm Company We have been very happy with the Level 3 service offered by Eurofins Lancaster Labs for viral clearance studies. The scientists expertise in understanding and performing our scale-down model experiments has been very good. Scientists are quite open and flexible in incorporating our customized ideas for study design, data collection and data reporting. - Director and Ph.D., Global Biologics Firm We are so confident in our Viral Clearance technical expertise, regulatory experience and study management approach, that we offer the only guarantee in the industry. We will work with you to design your viral clearance study, and if we do not meet your viral clearance goals, we will repeat it for free. It is a way for us to show our clients that we believe in our product and ensure that your clearance goals will be met. Approaching each study design as a collaboration between the client and our team, we have detailed discussions with the client regarding the product purification process and the clearance targets for each individual spiking virus. Our management team has over 80 years of combined experience in viral clearance, has served on multiple task forces, is actively engaged with global regulators and has helped many clients defend their data to regulatory agencies. This regulatory support continues for the life of the product. Because our team implements an ongoing best practices program to evaluate and optimize all the parameters of study design and performance, we evaluate multiple options for performing a study and offer a design that we can recommend and guarantee as the best way of achieving viral clearance targets. We offer several study options ranging from basic virus spiking to a complete turnkey model. For our Basic Service model, we provide the virus spike, and the client is on site to perform each process step. The client is also on site for our Enhanced Service model, but our staff will perform the less complicated steps (e.g., inactivation and viral filtration steps). For our Full Service model, we perform a technology transfer of the scaled down model (previously qualified by the client), and then our staff will perform the entire study without the client being present. Finally, our Turnkey Service model involves design and qualification of a scale down model and performance of the complete viral clearance study. The final data includes a CMC-ready scale down and viral clearance reports. For all stages throughout the development, manufacturing and release of your biological product, we offer comprehensive, fully cgmpcompliant viral clearance services, and all of our assays are fully validated to meet ICH Q2 requirements. Our new facility has four completely independent client suites, including laboratory and office space, which are conveniently located, providing constant access to our personnel during a client s stay. Each suite has separate keycard access, keeping all client information confidential. Viral clearance offerings include: A variety of validated and well characterized viral stocks to support animal- and human-derived products Purified virus stocks Viral stocks with titers of 10 7 pfu/ml or greater Validated qpcr assays Infectivity assays performed real-time Large volume assays Ongoing regulatory support upon study completion Disinfectant Efficacy and Cleaning Validation Studies designed to quantify the elimination of viruses during the cleaning procedures used at your manufacturing facility Facilities and Instrumentation: Multiple HEPA-filtered virus clearance labs Multiple AKTA chromatography systems Spectrometers, ph meter, Conductivity meters and other basic lab equipment Capacity to accommodate studies with minimal delay Beyond our state-of-the-art instrumentation and facilities, we have some of the industry s top scientific talent who transform science into an outstanding service experience. Approaching each study as a vested partnership, when a client s study succeeds, we all succeed. For more information, visit EurofinsLancasterLabs.com Bio/Pharmaceutical NEWS 4 Winter 2016

5 Electronic Notebooks: Implementation and utilization of new technology Transforming how raw data documentation is managed at Eurofins Lancaster Laboratories by Travis Emig, Senior Director, Pharmaceutical Services Eurofins Lancaster Laboratories has recently taken yet another innovative step to continue to improve processes and quality in our laboratory services portfolio by offering Electronic Notebooks (ELN). As noted by Quality Assurance Manager, Anjan Mittal, benefits of an electronic documentation system for raw data include improved quality and legibility of records. There is real-time elimination of data omission. Template QbD design dictates accurate, complete, and efficient experiments. Data specific to samples, equipment, materials, etc. are captured through validated scanning of bar codes, meaning a single record in LIMS can be used as source information for all subsequent uses. There is automation in creating PDF files for data package delivery. With customers implementing their own use of ELN based products, and today s regulatory environment, which is focused on electronic management of records and data integrity, the ELN implementation at Eurofins Lancaster Laboratories aligns with industry expectations for a third-party CRO. This product allows for more integrated partnerships with clients, will open the door for future connectivity with LIMS products, and will drive continued focus on control and integrity of electronic records. Challenges exist with developing and implementing an ELN system in a CRO operation. Besides the normal challenges any Pharmaceutical organization would face in design and validation of such a product, the CRO environment adds a huge variable, and that is customized requirements for each individual customer. An additional layer of product functionality was created to manage and link client parameters into the ELN product, allowing general experiment templates to be used for various clients. The logistics to procure hardware (laptops, scanners, WiFi) must also be managed. How has ELN already improved operations for Eurofins Lancaster Laboratories? Microbiology Manager Harolyn Clow stated, My area has already achieved a 50% reduction in preventable analyst errors in documentation. The ELN templates essentially check analysts work as it is being performed, so errors are identified and prevented before negatively impacting an experiment. The laboratories using ELN show appreciable reductions in errors and investigations. They note that raw data is always accessible, no need to locate paper notebooks to retrieve records. Batches and lot numbers for samples are searchable in the ELN system, and the status of test batch information is available in one location. Further, Pharmaceutical Chemistry Group Leader, Dana Cunningham, added, Management of reagent preparations has improved significantly, with clear records and labels that allow for direct scanning into an experiment record. As a supervisor, I like having the access to progress of each experiment I have assigned, from initiation through completion, data review, and data package. I have real time ability to view test status and no longer have to track down notebooks. How is Eurofins Lancaster Laboratories using the ELN product today? Microbiology, Water Chemistry, Reagent Preparation, Chemistry and Biologics testing all have several templates in production or development. A team of template developers led by John Jegla works in conjunction with laboratory management to identify opportunities and set requirements for new templates to be generated. What are next steps in expanding the use of the ELN product? As expertise with an ELN platform expands, review by exception is a feature that can be incorporated to streamline QA approval. Automated upload of results into With customers implementing their own use of ELN based products, and today s regulatory environment which is focused on electronic management of records and data integrity, the ELN implementation at Eurofins Lancaster Laboratories aligns with industry expectations for a third party CRO. View our Webinar Series Are you Effectively Monitoring your Contract Lab? Save the date for our upcoming webinar on February 11, 2016, to learn how to foster your relationships with contract partners to develop a quality surveillance program that will surpass FDA scrutiny. Visit our web site for details: com/webinars. For information and access to past webinars, visit: EurofinsLancasterLabs.com. Contact us LIMS is feasible. Capture of raw data from equipment such as balances is also being developed. Customers of Eurofins Lancaster Laboratories have already started to see ELN data reports in their final compiled data packages for various testing areas and the expectation is for the utilization of the product to expand tremendously through For more information, contact Biopharmaceutical Business Development at For information on services, literature requests or address changes, please contact: Bio/Pharmaceutical Business Development, or pha@lancasterlabs.com See how our Flexible Service Models can meet your project needs at: EurofinsLancasterLabs.com. Bio/Pharmaceutical NEWS 5 Winter 2016

6 Full-Time-Equivalent (FTE) enables clients to lock in dedicated staff, capacity and resources to meet GMP compliance in US and EU Working in our GMP-compliant facilities in the US and Europe, our trained FTE scientists use our infrastructure, quality systems, validated equipment and consumables to meet our clients project testing needs, while integrating our operations with client quality systems and SOPs. Throughout the 15 years we have offered the FTE service model, we have refined our FTE options to provide the most flexible approach available in the industry. Eurofins Lancaster Laboratories offers four unique choices designed to meet the testing needs of virtually any project, including: Traditional FTE Ideal for customers who know they have a level of work that requires a consistent, dedicated team and are looking to maintain a steady, monthly cost that is identified up front, this model is based on a minimum headcount of five, including a team leader and dedicated scientists to support a program for a minimum of one year. Hybrid FTE/FFS Ideal for method establishment on large stability and release programs, the method establishment (validation and/or transfer) activities are performed under an FTE agreement that is based on an estimated headcount and timeframe required to complete the work. Time spent on this phase is tracked and billed on a monthly basis against a blanket purchase order that is established up front. All subsequent stability and release work, along with storage and management of samples, is conducted and billed according to the Fee-For- Service (FFS) quote. Flexible FTE Ideal for clients who would like a dedicated team and a monthly invoice but are unable to predict the scope of work or total resources needed, this is our most flexible FTE option. We create a core FTE team, including a designated team leader and a minimum of one scientist, and monitor the testing needs to adjust capacity as needed. Team size is variable and can flex with sufficient notice and approval. Managed Hours FTE Ideal for clients who are looking for the benefits of a simplified invoicing process but do not have the work flow for a dedicated team, all hours are tracked and billed monthly according to agreed-upon rates. No matter which option is chosen, we determine the specific skill set needed for each project and assign team members based on the project s specialized needs to ensure all areas of expertise are covered. Staff members on FTE teams work very closely together to share expertise and strengthen the testing capability within the group. We can also shift resources to accommodate changes to projects and priorities as needed. With a history of providing FTE services for more than 15 years, 25% of our total work utilizes one of our FTE service model options. Our program allows substitution of FTE hours to accommodate services not typically included in FTE programs, such as microbiology, raw material assays or material characterization. We drive cost-control measures and eliminate rush surcharges for expedited testing to reduce overall project costs as well as generate customized metric reports on FTE team performance. Through our LabAccess.com SM portal, we offer 24/7 access to raw data and reports with a timely and secure window to comprehensive laboratory information. And we offer optional integration into client IT platforms, such as LIMS. Our FTE Programs typically support: Comprehensive stability and release programs for clinical and marketed products. Benefits to our FTE Solutions: Provides a high level of expertise with technical and productivity enhancements by offering a team dedicated to a single customer. Allows the client to lock in capacity and resources. Provides simplified payment options through monthly billing. Offers a high level of integration & customization to meet specific testing needs. Offers the ability to track the performance of the team. Method establishment, including method development, feasibility, optimization, cgmp qualification, validation and verification of compendial methods. Method Remediation. Options for Reporting and Deliverables Eurofins Lancaster Laboratories offers flexible deliverables and tools to demonstrate how our FTE model provides value to pharmaceutical and biopharmaceutical companies, including customized reports that work with our clients systems. Clients can choose the metric, frequency and appearance of reports, including but not limited to: Utilization Hours Per Activity Workload vs. Headcount Metrics Detailed Staffing Forecast Accountability Monthly Utilization Reports Productivity Scorecard Turnaround Time Quality Metric For more information, contact Biopharmaceutical Business Development at Bio/Pharmaceutical NEWS 6 Winter 2016

7 At Eurofins Lancaster Laboratories, we believe that our people provide our strength. Their dedication to quality, professional 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 Lancaster Laboratories an industry leader. With the Lab since 1984, Deb Marcuson has always appreciated the steady growth of the company, and in turn, that of her career. Whether transitioning from the Environmental Division to Foods to Pharma Product Testing in 1998, Deb s primary driver has always been developing one-on-one close relationships with her clients. As an FTE Group Leader since Aug 2011, Deb, and her team of 31 Analysts, Data Reviewers, and Group Leaders, forge a bond with their FTE client to understand and embrace their corporate culture, processes, and expectations to mirror their ways of doing things and serve as their off-site lab. What does your current job entail? As an FTE Group Leader my responsibilities include overseeing/managing Analysts and Data Reviewers for an FTE team to support the FTE client projects. This also includes daily communication with our client s Project Managers via conference calls, Instant Messaging, and /or . What is the scope of your group? We support developmental and stability studies to support FDA new drug filings. The size of the team fluctuates based on client s drug pipeline. Our core team typically has 16 Analysts, four Data Reviewers and two Group Leaders. During our largest team ramp, we had 30 Analysts, three Group Leaders and seven Data Reviewers. Our FTE team is unique in that we use the client s chromatog- People are the chemistry raphy system (Empower), client LIMS, client (yes we have a Eurofins Lancaster Labs (ELLI) address and a client address). To accommodate access to client s systems, we work using two PC s. One is linked to the ELLI network, and the other is linked to the client s network. To switch from the ELLI network to the client network we use a switching box. With a simple click, we can switch to the other network. That way we only need to use one keyboard and one monitor. What process improvements does your group initiate to serve clients better? Since we use our client s LIMS system for reporting, we have made several recommendations to improve the process. We have also participated in client internal discussions when the system is upgraded. Due to the volume of samples we test, our input is greatly valued by the FTE client since we are one of the primary users of the LIMS system. We also participated in our Client s Lean Initiative to minimize the number of client SOPs used by ELLI analysts. Prior to this initiative, analysts were following the client s SOPs, in conjunction with ELLI SOPs (to fill in the gaps) and numerous protocols required for the stability studies. The team had significant efficiency gains being able to use ELLI SOPs. You ve been here for over 30 years and seen countless changes. Is there anything that hasn t changed during your tenure? Lancaster Laboratories has always emphasized the importance of servicing our clients to the very best of our ability and to always maintain our high level of quality. This started with our founder Dr. Earl Hess, continued with past president Dr. Wilson Hershey and still continues with our current president Dr. Tim Oostdyk. And job security has also been very important to me. And when you re not working? During my time off, I look forward to trips to Portsmouth Island ( an 18- mile barrier island that is part of Cape Lookout National Seashore in North Carolina). My husband and I enjoy surf fishing there in the spring and fall. Our trips there are very relaxing and give me time to recharge my batteries. It is a remote island that is accessed by a family owned ferry service. The ferry is reservation only and very small (only holds about 4 6 vehicles). Once we are there, we can completely relax. There are no amenities on the island, just 10 rustic cabins managed by the National Park Service and the office where you can get ice and gas. We stay in our truck camper, better known as Deb s beach house the entire time we are there. What s really great about it is if you don t like the neighbors, we just move down the beach! Bio/Pharmaceutical NEWS 7 Winter 2016

8 Lancaster Laboratories 2425 New Holland Pike Lancaster, PA RETURN SERVICE REQUESTED Presorted Standard U.S. Postage PAID Lancaster, PA Permit No. 87 Find us us at... CASSS WCBP Washington, DC January Daniel Peckman, Biochemistry Manager, presenting: Using Micro Flow Imaging as a Stability Indicating Method. Jeri Ann Boose, Ph.D., Sr. Biopharmaceutical Director, Facilitator of Roundtable Session: Viral clearance and the use of advanced technologies such as NGS in the detection of adventitious agents in biologics. Biosimilars & Follow-On Philadelphia, PA March 2-4 Biologics 2016 Americas John Snyder, Ph.D., Biochemistry Research Fellow, presenting: A Review of Current Analytical Methods and Recent Advancements in the Characterization of Biotherapeutic Monoclonal antibodies. BioProcess Oakland, CA March International West CASSS Bioassays Silver Spring, MD April 4-5 Extractables & Leachables Bethesda, MD May 9-11 USA 2016 Get the inside look through our Virtual Tours Tour our state-of-theart laboratories online for an in-depth look at our expertise, capabilities and capacity at: EurofinsLancasterLabs.com, under News & Events. Bio/Pharmaceutical NEWS is published for clients, employees and associates of Eurofins Lancaster Laboratories Editor: Lisa Bamford (717) , Fax: (717)