New Category 5 suites deliver ADC free-drug testing & payload prep at the industry’s only laboratory network for highly potent compounds of its kind
Daniel Peckman, M.S., BioPharmaceutical Sr Manager, Eurofins Lancaster Laboratories, US, DanielPeckman@EurofinsUS.com
Materials, such as the cytotoxic payload of an antibody drug- conjugate (ADC), can require strict handling guidelines and engineering controls such as dedicated isolators in order to protect those that come in contact with them due to their extremely low occupational exposure levels. With a significant increase in client requests for safe testing options of highly potent/toxic materials, Eurofins BioPharma Product Testing has built new 1,100 ft2 and 660 ft2 Category 5 laboratory suites with space for expansion. The addition of Category 5 testing areas within the Eurofins network in Lancaster, PA, and Columbia, MO, allow for specific stability and release testing to be performed on finished products that present safety challenges for traditional chemistry laboratories.
Eurofins’ state-of-the-art labs are built to safely test Category 5 materials where HPLC or spectrophotometric methods are required. Capabilities include controlled/ isolated receipt of shipped materials, weighing and solution preparation in isolation, and LC and UV-Vis analysis of APIs, drug substances or drug products. The increased control ensures the safety of the analysts while maintaining the same testing platforms applied in non-Cat 5 areas of the laboratory.
The suites comprise an entry corridor leading into a controlled access preparation room connected to an active room via entry and exit anterooms. Eurofins’ unique suite layout and design provide for a single directional flow of personnel and a cascade pressure gradient to protect the integrity of the inner room and isolate the active area from all other lab space.
Eurofins’ New CAT5 Labs offer:
- The ability to include free-drug testing of CAT5 level payloads within clients’ ADC stability and release testing panel
- Space to expand for additional testing on Category 5 compounds in the future
- Dedicated weighing and preparation isolators, HPLCs with UV and PDA detection, dedicated Biosafety cabinets and UV-Vis spectrophotometric capabilities.
Applications can range from potent compound weighing/aliquoting projects to HPLC testing for the determination of size, purity or chirality of APIs or free-drug payload.
With this new service offering, Eurofins BioPharma Product Testing delivers a one-stop-shop for comprehensive QC testing of antibody drug conjugates.
For more information, visit: www.eurofins.com/biopharma-services/product-testing/services/biopharma-product-testing-services/category-5-highlypotenttoxic- materials-testing/
N-Nitrosamine contamination of drug products: regulatory challenges in a constantly evolving scenario
Davide Tartaglione, Senior PharmaConsultant, Eurofins BioPharma Product Testing, Italy, DavideTartaglione@eurofins.com
Two years have passed since N-nitrosodimethylamine (NDMA) contamination was first discovered in a batch of Valsartan. The carcinogenic risk associated with compounds of the N-nitroso family and the great media coverage led to one of the widest mobilisations of scientists and regulatory experts. After similar contamination was identified in different drugs such as ranitidine, nizatidine, and metformin, it became clear that the issue was not limited to a short list of manufacturers. FDA, EMA, and other international agencies started an intense collaboration to share experience, data, and knowledge.
At first, regulators had to carefully balance possible drug shortages with the need to ensure patients health; marketing of contaminated drugs with a valid clinical alternative, such as ranitidine, was suspended in the US and Europe as a precaution, although the decision does not yet seem definitive. Where this approach was not feasible (i.e. for Sartans), strict temporary limits on levels of these impurities were introduced in the Test section of the related Ph. Eur. Monographs as well as a general chapter (2.4.36) for all active substances. Regulatory decisions were based upon the necessity of increasingly sensitive and specific testing methods (such as Hi-Res techniques), and the common opinion that an in-depth review of the manufacturing processes would be needed to mitigate the risk of contamination.
As a result, a risk based evaluation for all drugs is required by EMA. The extended deadline for this step is now March 2021. In a recent guidance for industry issued by FDA at the beginning of September, the US agency fully aligned with Europe. Notably, biological products are now included, even though they were not initially considered due to very low risk of contamination. This change in approach aligns with the agency’s expectations to cover all marketed and newly submitted drugs.
EMA is also running a lessons-learned exercise. As a result, the international guidelines that are now effective for controlling mutagenic impurities, such as ICH M7, will most likely undergo a long and complex revision cycle to avoid the repetition of similar situations in the future.
Eurofins BioPharma Product Testing network of GMP labs has the capability and capacity to assist clients through all the steps of the investigation process – from initial risk assessment to analytical methods validation and from screening and confirmatory testing to routine quality control in order to confirm nitrosamine levels in drug substances and drug products.
For more information, visit: www.eurofins.com/bpt
Eurofins’ new WebLab System offers real-time formulation analysis services
Junko Imoto, Research Fellow, Eurofins BioPharma Product Testing Kyoto, JunkoImoto@eurofins.com
There are a variety of dosage forms in pharmaceuticals, and formulation development is conducted daily so that the active ingredients work effectively and also patients can take them easily. In formulation development, it is very important not only to make sure that the pharmaceuticals are manufactured as designed; it is also important to analyse the structure of the drug product in order to investigate the cause when an abnormality occurs in the product after the market launch.
Eurofins BioPharma Product Testing Kyoto (BPT Kyoto) uses various imaging technologies to help visualise and analyse the structure of drug products. In formulation analysis, especially imaging analysis, it is critical to decide which part of the formulation should be focused on, which differs depending on each customer.
Eurofins BPT Kyoto has started its WebLab service in 2020. With this service, an analysis screen can be connected with the customer’s PC using the internet. A customer can witness the analytical work in real-time, without visiting the Eurofins Lab in Japan, by simply turning on the PC switch at the given analytical time. It is also possible to connect with multiple sites. Therefore, customers can efficiently and accurately perform their desired measurements by directly instructing analysts what they want them to pay more attention to, pointing out the positions where they want to analyse, and by having discussions with analysts, all in real-time manner. The WebLab system is now utilised as one of the best tools of working remotely in this COVID-19 situation.
Eurofins BPT Kyoto joined the Eurofins Group via Astellas Pharma in 2018 and has extensive experience in the field of formulation analysis. By utilising the WebLab system, it is possible to meet customer demands more reliably and in a timely manner.
For more information, visit: www.eurofins.co.jp/eurofins-biopharma-product-testing-kyoto/analytical-testing-services/advanced-expert-analysis/
Injectable products : Eurofins BPT France is at the forefront of packaging testing
Emmanuelle Ory, Testing Business Unit Manager, Eurofins BioPharma Product Testing France, Les Ulis, email@example.com
Regulatory changes in the European Pharmacopeia in 2019 have been very challenging for most laboratories. New specifications for autoclave cycles led to significant decrease in the number of compliant cycles. A solution needed to be found quickly to ensure customer satisfaction and product safety. With years of experience, Eurofins BioPharma Product Testing (BPT) quickly responded and achieved qualification of all autoclaves and now delivers 100% compliant cycles for:
- Rubber closure according to Eur. Ph. 3.2.9 and USP NF <381>
- Glass, from a nominal volume of 1mL to 500mL according to Eur. Ph. 3.2.1 and USP NF <660>
- Designed qualified cycles for specific volumes
At the same time, Eurofins BPT France increased its capacity with the acquisition of new autoclaves, and dedicated a team of analysts to this specific activity.
Eurofins BPT France is now able to deliver analytical results for more than 100 batches weekly – not only for large and medium size biopharma companies which already trust Eurofins for many years, but also for new clients. Analysis of heavy metals on glass containers by AAS, ICP-OES, ICP-AES or ICP-MS is also part of Eurofins’ expertise, and its scientists are working closely with regulatory agencies on the topic of elemental impurities testing.
Eurofins BPT France can support every client involved in injectable solutions production. With almost 10 years of experience in packaging quality control testing, a scope of advanced equipment, including qualified autoclaves needed to simulate use in production conditions, the laboratory performs full testing of glass and rubber closures in accordance with GMP and European and American Pharmacopeias.
For more information, visit: www.eurofins.com/bpt
Eurofins Bioanalytical Services expands technology footprint with the addition of Novocyte Quanteon™
Kristy Galkowski, Marketing Manager, Eurofins BioPharma Bioanalytical Services, US, KristenGalkowski@eurofins.com
Today’s leading scientists continuously seek new approaches to achieve a more holistic understanding of the cell and cellular mechanisms. These highly differentiated cellular workflows provide a deeper insight into live cell samples by providing both quantitative and phenotypic results, faster. The Quanteon is a 4 laser flow cytometer that can be configured with up to 25 independent photomultipliers for meeting the most demanding sample panels. The proprietary photomultiplier technology employed in the Quanteon provides superior sensitivity, stability, and a 7.2 log dynamic range. When developing large colour panels, the Quanteon saves hours of setup and analysis time. Superior fluidics provide steady and consistent sample delivery, with high reproducibility and absolute counts, without the use of expensive beads, which will save clients time and money.
Complementing its existing suite of Flow Cytometry platforms, this technology is highly advantageous for use in decision-making throughout the drug development life cycle, from early preclinical through to late phase clinical studies.
Eurofins commitment is to stay at the forefront of technology by offering the optimal choice in a fit-for-purpose approach. Its scientists now have the flexibility to choose from 25 fluorescent channels from a combination of four lasers (405, 488, 561, and 637nm) and superior sensitivity and resolutions to meet clients’ needs. Eurofins Bioanalytical Services custom designs biomarker solutions in a regulated or non-regulated environment based upon Context of Use to match clients’ drug development programmes.
With industry-leading biomarker solutions, complemented with traditional ligand-binding assays and study management services, clients can accelerate research outcomes with early proof-of-concept studies and throughout the development life cycle.
For more information, visit: www.eurofins.com/bioanalyticalservices
Eurofins PSS delivers scientific laboratory management and testing solutions at the client’s site when needed the most
Lisa Collins, PSS US West Coast Business Development Specialist, LisaCollins@eurofinsUS.com; Carolyn Garrett, PSS US East Coast Principal Business Development Specialist, CarolynGarrett@eurofinsUS.com
Clients’ challenge case study: When the global crisis of COVID-19 hit, many PSS clients did not have existing policies/procedures in place to support employees who needed to remain onsite and those who now had to work remotely. Additionally, cost control measures were instigated in preparation for the financial impact of COVID- 19 with hiring freezes proving to be the most common strategy. Programmes needed to advance and still required support; companies found themselves unable to hire their own staff, recognising temps as typically not an optimal option. With internal management from resources already stretched, they searched for alternative solutions.
PSS Background/Solution: A global, award-winning managed service provider, Eurofins PSS Insourcing Solutions® (PSS) places its people at clients’ sites dedicated to managing laboratory services while eliminating headcount, co-employment and project management worries with 2,500 employees, 85 sites, 17 countries. As COVID-19 spread globally, the PSS Leadership Team pivoted and implemented a comprehensive COVID Response Action Plan to ensure employees’ safety and maintain business continuity. A Crisis Management Team was established by working with clients to identify critical work to be performed onsite/ remotely, culminating in a COVID Preparation Response Action Plan, including:
- Comprehensive communication plan (employees and clients)
- Physical assessments
- Work schedules adhering to social distancing guidelines
- Checklists/guidelines for an identified illness
- Contact lists/backups
- Training plans
- Daily inspiration to encourage employee’s engagement/wellness
Since Eurofins PSS has decades of laboratory management experience, global teams were prepared to proficiently recruit, hire, manage, and perform laboratory and manufacturing operations, while using clients’ quality systems/equipment and accommodating groups of any size/length of term to safely maintain business continuity when client headcounts were not available.
Keys to PSS success? The PSS approach is systemised and proven successful, and clients across the globe see value in having a strategic partner now more than ever. PSS forges a strong partnership with clients, understanding expectations, agreeing on metrics, and establishing on-site leadership who report to PSS management to ensure the team is motivated, engaged, and exceeds client expectations. Celebrating 18 years with 15 strategic partner awards for delighting clients, HR and great place to work best practices, PSS customises solutions to fit clients’ individual needs. The PSS philosophy: “Find great people, take great care of them, so they in turn will take great care of clients” is at the heart of every action and has never been more crucial than when faced with a global pandemic.
A Client’s Feedback: “We are very appreciative of Eurofins employees supporting our group at this difficult time. Eurofins colleagues have been on-site delivering quality work with added stress on themselves and their families having to leave their homes and commute to labs while interacting with others. Eurofins employees have maintained professionalism helping to identify areas of improvement for social distancing guidelines to ensure safety. Thank you for all of your dedication and commitment!”
For more information, visit: www.eurofins.com/biopharma-services/product-testing/services/professional-scientific-services/