Webinars
Live Webinar
Storage and Stability Series: Stability Studies in R&D Support
21st November 2024 | 3-4pm CEST
Forced degradation studies identify potential degradation products and pathways by exposing the drug to extreme conditions, while comparative stability studies evaluate the stability profiles of different formulations or batches. Holding time studies validate the stability of bulk drug substances during manufacturing hold periods.
During the webinar we will discuss:
- Forced degradation
- Holding time
- Choice of formulation
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Live Webinar
Storage and Stability Series: Management of internal and external flows: the importance of validating the transport plan for a stability study
4th December 2024 | 3-4pm CEST
Discussion on the technical characteristics of storage equipment and conduct temperature/humidity mapping and on-call and maintenance: the keys to success.
During the webinar we will discuss:
- Technical characteristics of storage equipment
- Conduct temperature/humidity mapping
- On-call and maintenance: the keys to success
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Live Webinar
Storage and Stability Series: Exploitation of Stability Data
12th December 2024 | 3-4pm CEST
The use of stability data allows extrapolation of shelf life, analysis of off-trend data and definition of specifications (release and shelf life) based on the different stability studies.
During the webinar we will discuss:
- Extrapolation of shelf-life
- Out of Trend (OOT)
- Specifications of product
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Live Webinar
Storage and Stability Series: Guidelines for Stability Testing of Biotechnological and Biological Products
23rd January 2025 | 3-4pm CEST
ICH Q5C provides guidelines for conducting stability testing on biotechnological and biological products to ensure their quality, safety, and efficacy over their proposed shelf life. It covers testing parameters, storage conditions, and data analysis methods specific to these complex products.
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On-Demand Webinar
Accelerate biologics product release with seamless viral testing
Viral contaminants can be introduced throughout the complex biopharmaceutical manufacturing process via any number of mechanisms, including raw materials, cell banks, and manufacturing personnel. Accurate, timely Unprocessed Bulk (UPB)/Bulk harvest testing is critical not only to product safety, but also to prevent contamination of downstream processing equipment which results in lengthy and costly decontamination procedures and critical product shortages. Streamline your product development by partnering with a vendor that offers integrated testing services at a single location. This approach ensures continuous support throughout the product lifecycle and provides flexible testing solutions to address the growing complexity and diversity of biologics products.
During this webinar, we will dive into:
- A brief introduction to key concepts and regulatory updates
- Unprocessed Bulk Testing Requirements, Viral Assays & non-traditional methods, including Next Generation Sequencing (NGS)
- Transmission Electron Microscopy (TEM) testing of Unprocessed Bulk via improved thin-sectioning method
- Applying data for Viral Clearance testing
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On Demand Webinar
Storage and Stability Series: Technical secrets for maintaining storage conditions
Discussion on the technical characteristics of storage equipment and conduct temperature/humidity mapping and on-call and maintenance: the keys to success.
During the webinar we will discuss:
- Technical characteristics of storage equipment
- Conduct temperature/humidity mapping
- On-call and maintenance: the keys to success
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On Demand Webinar
Storage and Stability Series: Photostability, Transport Stress, and In-Use Studies for Drug Products
Photostability testing (ICH Q1B) assesses the impact of light exposure on drug substances and products, while transport stress and in-use studies evaluate the effects of shipping conditions and product handling after opening, respectively.
During the webinar we will discuss:
- Photostability ICHQ1B and forced degradation
- Transport Stress
- In-use studies
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On Demand Webinar
Storage and Stability Series: The Key to Successful Stability Storage
Construct the design of a storage of a stability study based on the Ishikawa method: medium, material, methods, measurements, machines and manpower.
During the webinar we will discuss:
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On Demand Webinar
Storage and Stability Series: Overview of Stability Testing Requirements in ICH Q1A (R2) Guideline
The ICH Q1A guideline provides a framework for stability testing of new drug substances and products to ensure their quality, safety, and efficacy over time. It outlines requirements for testing conditions, storage, and the duration necessary to establish stability profiles.
During the webinar we will discuss:
- Life cycle of drug product
- Testing frequency and storage conditions
- Bracketing/Matrixing (ICHQ1D)
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On Demand Webinar
Virus Strain, Selection, and Titer: Maximizing Results for Viral Clearance Studies
Ensuring that viral clearance studies achieve the needed log reduction values (LRV) or viral reduction values (VRV) for regulatory requirements is critical in avoiding delays in clinical trials or manufacturing schedules. While researchers and contract manufacturing organizations (CMOs) may be knowledgeable about their specific molecules and purification processes, they often lack comprehensive understanding of the various factors influencing virus selection for clearance studies.
The selection of specific viral strains, ideally a non-human infectious model virus, is critical to ensuring the viral challenge to the purification evaluation is representative of endogenous or introduced viral contaminants. The chosen strains must also align with regulatory guidelines based on intended filing location, product development stage, and exposure risks. Additionally, the evaluation of viral clearance should consider worst-case scenarios, including factors such as time, temperature, pH, and robust virus titers.
The critical aspects of viral clearance studies are essential for meeting regulatory standards and preventing delays in clinical trials or manufacturing. Join our webinar as we explore:
- Understanding the significance of achieving log reduction values or viral reduction.
- Identifying common gaps in knowledge among researchers and contract manufacturing organizations.
- Importance of selecting appropriate viral strains, including non-human infectious models.
- Consideration of worst-case scenarios in viral clearance evaluation.
- Balancing minimal virus volume with maximum challenge by adjusting environmental and solution matrix conditions.
- Highlighting crucial components of viral clearance studies to ensure successful outcomes and regulatory compliances.
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On Demand Webinar
Determining How to Set up a Comparability Study to Validate a Matrix for Rapid Mycoplasma Detection Testing
With the advent of rapid mycoplasma detection, regulatory agencies have been stringently requiring comparisons of any developed rapid method to the compendial-derived methods. Recently, both the FDA and EMA have required comparability studies for every unique matrix, as filed, for any rapid mycoplasma detection method used to determine whether mycoplasma are present within the product. These studies are necessary to determine the Limit of Detection, the robustness, and the specificity of the rapid method for each matrix as per USP <1223> and Ph. Eur. 5.1.6. Each matrix is different, and may require a different approach to fulfilling the requirements set down by the agencies.
In this webinar, we will discuss:
- The rapid qPCR methods available at Eurofins: Thermofisher’s MycoSEQ and Biomeriuex’s Biofire
- The regulations the agencies refer to
- Decisions to determine the best approach for a matrix to be validated on a rapid mycoplasma detection method
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On Demand Webinar
Selecting the Correct Deterministic CCIT Method for your Container Closure System
Pharmaceutical products and medical devices are expected to be free from microbial contamination and safe to use from production through the end of their shelf-life. A container closure system needs to be able to contain the product without leaks while also providing a barrier to keep harmful materials from reaching the drug product. Due to the variety of product/packaging configurations and regulations, there is no one method of container closure integrity testing (CCIT) that can test all products. Per USP <1207> there are multiple techniques that can be used for CCIT; and determining the best method for a product requires understanding of the product being tested and the technique being employed.
The purpose of this webinar is to:
- understand the basic CCIT regulations.
- examine the different deterministic techniques available, along with advantages and disadvantages of each.
- review how a newer technique, Carbon Dioxide Headspace testing, can be utilized as a tool in CCIT, along with the more established methods.
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On Demand Webinar
Explore the Complexities of Compendia Testing and Maintain Compliance
Maintaining compendia compliance in a rapidly changing and unpredictable industry magnifies the complexity of testing raw materials. Adapting to the constant flux of a dynamic and unpredictable industry poses significant complexity to maintain compliance, especially with ever evolving global compendia. Monitoring multiple compendia (USP, EP, BP, JP) for updates, revisions, new text, etc. is a manual and tedious process. Do you have the expertise, staff and time to perform the daily tasks required to remain compliant with compendia updates?
In this webinar, we will explore the complexities of compendia surveillance and Eurofins BioPharma Product Testing’s processes and industry leadership position in maintaining compliance, including:
- Processes needed to properly monitor global compendia
- Technology-based solutions for information management
- Information sharing across the Eurofins global network
- Relationship with the USP
- Industry involvement and leadership in updates and new content
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On-Demand Webinar
Syringe Testing: Navigating Extensive Testing to Ensure Patient Safety
With the growing desire for end users to self-administer pharmaceutical products to treat chronic illnesses, the need for pre-filled syringes and autoinjectors has increased, compared to the traditional vial and syringe delivery. While companies are keenly focused on developing the product that goes inside the syringe, this growing trend requires companies to navigate a complex landscape of testing requirements of syringes in order to comply with FDA and international health and safety regulations. Therefore, developing an appropriate test plan for syringe functionality testing is of utmost importance with the globalization of the Medical Device and Pharmaceutical products to ensure patient safety.
During this webinar, we will share insights, testing requirements, commonly performed tests, and test plan rationales to save you time and avoid delays in your product development cycle, including:
- Overview of various testing standards required to get your product to market
- The current status and expectations of regulatory agencies
- How to design a test plan for design verification or lot release of the product
- Answers to common syringe testing questions
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On-Demand Webinar
A Roadmap to Choosing the Right Mycoplasma Testing Method for your Drug Product
Detection of mycoplasmas is a time consuming task. Once detected, the typical course of action is to eradicate the affected lot with intensive cleaning and verification so that the raw materials used are clean of the contamination.
Traditional microbiological methods used to detect mycoplasma, such as direct culture and indicator cell culture, are well established and reliable, but have several limitations. To overcome these limitations, NAT method (Nucleic Acid Techniques) detection of mycoplasma is becoming more accepted. NAT methods, such as MycoSEQ, MycoTOOL and Biofire are faster, but they require specialization in order to be properly performed. By utilizing the traditional compendial methods and rapid NAT assays, detection of mycoplasma in a variety of sample matrices can be achieved.
During this webinar, our experts will take a deep dive into the various Mycoplasma testing methods, including:
- A comparison of available Mycoplasma testing methods, including pros and cons for each method
- Guidance for choosing traditional compendial methods or rapid NAT assays for a given a sample matrix and timeline requirements
- A summary of applications that are best suited for rapid methods
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On-Demand Webinar
Transition your Therapeutic Program from R&D Cell Line Development to GMP Bank Manufacture in Preparation for Clinical Trials
Demand is growing for mammalian cell banking in support of the monoclonal antibody therapeutic and cell and gene therapy fields. Proper cell line development followed by GMP banking is required in order to introduce your therapeutic product candidate into clinical trials. In addition to protein/viral production levels and molecule structural attributes, regulatory considerations are needed during final clone selection prior to transitioning to GMP banking.
During this webinar, our experts will focus on mammalian cell line development and GMP banking requirements to transition your research from an R&D environment to the GMP regulated manufacturing world to take your molecule into the clinic. Some of the topics that will be discussed during this webinar include:
- Cell line development considerations for CHO and HEK-293/Sf9
- Cell line selection and clonality
- GMP documentation and GMP cell bank production
- Considerations for characterization and release testing of production cells banks for clinical use
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On-Demand Webinar
Verify the Safety of your Bioreactor with an Expedited UPB Release Testing Strategy
Contaminants such as viruses, bacteria, and fungi can enter the bioreactor during the biopharmaceutical manufacturing process. Due to this potential risk, a comprehensive biosafety testing strategy for Unprocessed Bulk (UPB) materials can help identify, take quick corrective actions to prevent future occurrences, and minimize costly delays in your pipeline.
Join us for a webinar to discuss unprocessed bulk testing approaches, logistics, and regulatory considerations to reduce the risk of contamination, including:
- Common test methods used to assess UPB Biosafety, including Mycoplasma, IVAA, MMV PCR and TEM.
- Testing strategies and turnaround times, including a rapid, 21-day approach.
- Use of risk assessments to determine the best testing strategy.
- Phase-appropriate validation considerations for early clinical trial stages through late stage and BLA filings.
- Logistics & execution, including sample submission, online ordering, raw data availability, Certificates of Analysis and more.
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On-Demand Webinar
Considerations for Cell Banking in Support of Cell and Gene Therapy Manufacturing
Demand is growing for mammalian cell banking in support of the cell and gene therapy field, following strict GMP regulations and tight timelines, to bring the novel biologic products to market faster. It is important to understand the difference between cell banking in support of traditional biologics, such as monoclonal antibodies using CHO cells, and cell banking in support of viral vector manufacturing.
During this webinar, our experts will focus on mammalian cell banking and cell line characterization with a deep dive into CHO and HEK293 cells, including:
- Current and future needs for cell banking in support of biologics manufacturing including cell and gene therapies
- The expectations around production and testing of producer cells or cells for transfection as they compare to CHO cells for biologics manufacturing
- Cell line manufacturing documentation, best practices, and necessary compliance controls
- Considerations for characterization and release testing of production cells banks
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On-Demand Webinar
Allogeneic Stem Cell Testing: From Donor to Transplant
The development of Allogeneic Cell Therapies is vastly different than traditional biopharmaceutical products, including other cell and gene therapy products, and the complexities of this novel therapeutic treatment span the development pipeline.
With the increasing prevalence of allogeneic cell transplantation (allo-HCT), the importance of securing a cellular product safely from a donor, and ensuring that the product is without additional risk to the recipient, continues to be of critical importance.
Please join industry leaders from Eurofins VRL and Eurofins BioPharma Product Testing as we share our expertise in testing allo-HCT for routine collection and storage of cells for use in transplantation, immune therapies and other medically-validated indications.
During this webinar, our experts will discuss:
- Required testing for donor source cells: Infectious Disease
- Relevant donor source testing: Sterility, Endotoxin, Mycoplasma
- Determining Eligibility
- Post cell processing/manufacturing GMP biosafety testing
- The need to repeat the infectious disease testing
- Specialized testing based upon raw materials/reagents used in cell processing
- Relevant testing and why it is performed
- Technical and regulatory considerations
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On-Demand Webinar
Viral Clearance – Challenge your Downstream Process Steps
Biologic manufacturing processes inherently have the potential to become contaminated with a virus. Process inputs, downstream purification, and final substance/product have to be assessed for potential viral contaminations. A well-designed viral clearance study is a complementary part of the overall virus testing and safety strategy for biologics. These are custom for each product and process. This webinar will focus on the downstream purification process and the need to perform viral clearance studies to support the manufacture of biologics.
During this webinar, our experts will discuss:
- Key factors to consider when designing and executing a clearance study from risk assessment to virus selection and service models to meet client needs.
- The steps for setting up a successful viral clearance study using a typical CHO process as an example
- Regulatory expectations and technical requirements
- Executing viral clearance studies in partnership or under a process transfer
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On-Demand Webinar
Minimize Risks and Enhance Speed and Flexibility with Sterile Fill/Finish Support for Clinical Supplies
Industry changes, such as shorter timelines and increased product complexity, can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns. Additionally, the advent of personalized medicines brings challenges to manufacturing and supply chain structure, emphasizing the need for speed and flexibility.
Join Eurofins BioPharma Product Testing and Vanrx (now part of Cytiva), for an in-depth discussion covering ways to eliminate human error and other associated risks when producing small batches of sterile GMP product for Phase 1 and 2 clinical trials. Learn how we can help increase speed and flexibility to drive your drug product into the clinic, and ultimately to patients faster with:
- In-process capabilities for sterile fill/finish manufacturing
- An overview of large and small molecule product types supported, including cell and gene therapy products, personalized medicines, and more
- An in-depth look at the design specifications of the Vanrx Microcell Vial Filler and the benefits of using a closed robotic system for aseptic filling
- A comprehensive overview of the specifications supported, such as batch sizes, vial types and container closures, options for sterile filtrations, labeling, kitting, distribution and logistics, and more
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On-Demand Webinar
Learn how your discovery and bioanalytical strategies impact IND-enabling program design!
For large molecule lead candidates, your discovery and bioanalytical strategies can either accelerate your time to the clinic or create hurdles along the way. These strategies are critical in identifying optimal lead candidates early, streamlining CMC testing assays, and developing bioanalytical methods that are robust and can be validated. Discovery and bioanalytical strategies also influence your nonclinical development program and support your IND-enabling studies to ensure your study findings translate to Phase I and beyond.
On May 26th, Eurofins and Sinclair Research teamed up for our live webinar “Getting from R&D to IND: How discovery and bioanalytical strategy influence nonclinical development program design” presented by:
- Francisca Neethling, Business Line Leader, Biotherapeutics, Eurofins Discovery
- Stanley Prince, Senior Scientific Advisor, Biologics, Eurofins BioPharma Product Testing
- Bo Kowalczyk, Senior Vice President, Eurofins Pharma BioAnalytics Services US Inc
- Tina Rogers, Senior Scientific Advisor, Sinclair Research
This webinar will cover discovery and bioanalytical strategy considerations and how they influence your nonclinical development program and support your IND-enabling studies.
In our webinar, Sinclair and Eurofins will help you learn about:
- Discovery considerations to identify lead candidates, characterization and advantages of use for antibody generation
- Biopharmaceutical product testing considerations to include GMP cell banking and downstream antibody development testing
- Considerations for your bioanalytical large molecule program to include attributes of PK and ADA assays, the pros and cons of commercial vs custom reagents and approaches for ADA assays in preclinical vs clinical development
- IND-enabling program design considerations for large molecules
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On-Demand Webinar
Decrease Needle to Needle Time for Autologous Cell Therapies with Rapid Biosafety Testing
The development of Autologous Cell Therapies is vastly different than traditional biopharmaceutical products, or even other cell and gene therapy products, and the complexities of this novel therapeutic treatment span the development pipeline.
One primary concern for patients who may be critically ill, or have compromised immune systems, is testing to ensure the biosafety of the cells prior to delivery back to patients. With patients awaiting their customized cell therapy treatments, timing is critically important.
Biosafety testing for Autologous Cell Therapies can be expedited with the proper instrumentation, regulatory knowledge, and scientific expertise.
During this webinar, our experts will discuss relevant biosafety testing solutions to help rapidly deliver results for the patients to receive their modified cells and help support these new therapeutic approaches in the autologous cell therapy area, including:
- Rapid Microbial Detection Testing
- Rapid Mycoplasma Testing
- Endotoxin Testing
Our experts will discuss various aspects of these testing solutions, including instrumentation required, validation of the test methods, method suitability B&F requirements, timelines for results, and more.
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On-Demand Webinar
Isotopic Labeling: Planning for the Synthesis of a Labeled Drug
Isotopic labeling of pharmaceutical drugs is a technique used to determine a drug’s fate in biological systems. The radio tag used in this method allows for easier detection of not only the parent molecule, but also the metabolic processes. Carbon 14 and tritium are common isotopic labels introduced into drug substances. The sourcing, handling, and manufacturing of these unique compounds require specialized expertise and instrumentation, trained chemists, and an NRC license to perform this work. In addition, compliance with ICH Q7 Section 19 Good Manufacturing Practices (GMP) guidance for the synthesis of radiolabeled Active Pharmaceutical Ingredients (APIs) for use in clinical trials must be followed.
This webinar will profile some of the unique facets of Isotopic labeling, as well as an overview of the processes, regulations, and other topics to consider when planning for the synthesis of a labeled drug.
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On-Demand Webinar
Bio/Pharmaceutical Package Testing: Avoid Thinking Strictly Inside the Box
Companies are often so keenly focused on developing the product inside the box that they can sometimes miss critical requirements for the package that is intended to protect it. Designing safe packaging that will protect products during 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, we will share insights and test plans to demonstrate how focusing on the packaging for your product can help to save you time and avoid delays in your product development, including:
- 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 techniques
- The current status and expectations of the FDA
- How to design a test plan to meet the supply chain rigors
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On-Demand Webinar
Testing of Bioprocess Residual Impurities in Gene Therapy Products
The manufacture of gene therapy products can be a complicated process. Multiple cell culture systems and a variety of process additives are often necessary to produce vector intermediates and the final bulk drug substance. To ensure the safety and efficacy of gene therapy products administered to patients, manufacturers are expected to measure and control impurities in drug substance, as well as manufacturing intermediates (where applicable), including host cell, vector components and process additives. Tracking the clearance of these residuals is also an essential part of process development and characterization. Due to the complex nature of gene therapy product manufacture, analytical method development and validation of these methods can be challenging. Furthermore, detailed regulatory guidance on acceptable limits are not available for all possible residuals.
During this presentation, you will learn:
- Typical residuals associated with the production of gene therapeutics
- Analytical approaches for residuals testing
- Challenges with platform method technology for residuals
- How to deal with matrix effect
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On-Demand Webinar
Burkholderia cepacia complex (Bcc) testing for Non-Sterile Water-Based Drug Products is coming—Get ahead of the game
During this webinar, our expert Holly Deitrick will present an overview of Burkholderia cepacia complex (Bcc) testing, testing for absence of Bcc, the FDA Guidance on prevention and detection of Bcc microorganisms, and how Eurofins BioPharma Product Testing can support your Bcc testing needs.
Topics Include:
- The history of Burkholderia cepacia complex
- The health risks associated with these microorganisms
- Recalls associated with contamination of BCC organisms and the lessons learned
- A glimpse of the current USP draft for BCC testing (USP chapter <60>)
- Burkholderia cepacia test methodology and best practices
- And more
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On-Demand Webinar
Navigating the Challenges of Residual Solvents in Pharmaceutical Products According to USP <467> <1467> and ICH Q3C Regulatory Guidelines
Understanding the regulatory expectations of residual solvents is not always easy, especially the recently published changes from the USP. During this webinar, Eurofins BioPharma Product Testing’s experts will provide a detailed summary of the changes and logical approaches for satisfying the new USP instruction, including approaches for a wide range of product types to help solve your residual solvents challenges with practical and cost effective strategies. We will share case studies addressing problematic solvents and the technical path forward. This webinar will also include:
- A Review of USP Screening Residual Solvents for Excipients, Drug Substances and Drug Products
- An Overview of limit vs. quantitation procedures and <1467> validation
- Options for Class 2, Mix C and Class 3 Residual Solvents testing
- Case studies for problematic solvents and the strategy Eurofins BioPharma Product Testing uses for successful testing
- Discussions on NCE or non-compendial test articles and ICH Q3C
Presenters:
 Erika Guerrero Principal Scientist/Group Leader Eurofins BioPharma Product Testing
|
 Danielle Newton Senior Scientist/Group Leader Eurofins BioPharma Product Testing
|
 Harley WilcoxSmall Molecule Senior Scientific Advisor Eurofins BioPharma Product Testing |
Click here to watch this on-demand webinar
The Division of Pharmacy Professional Development at the University of Wisconsin and Eurofins BioPharma Product Testing are proud to bring you this live webinar.
On-Demand Webinar
Cell Based Bioassays
Cell based bioassays are critical to determining the potency of biopharmaceuticals. The ICHQ6 B defines potency as “The measure of the biological activity using a quantitative biological assay based on the attribute of the product which is linked to the relevant biological properties.” Potency directly reflects the subtleties of the tertiary and quaternary structure of a biopharmaceutical in a manner in which physicochemical methods are incapable. But cell bioassays are also challenging as they involve use of living systems and their inherent variability. This webinar will discuss:
- Types of bioassays
- Challenges
- Lab design
- Development and Validation
Presenter:
Glenn Petrie, Ph.D.
Biologics Senior Scientific Advisor
Eurofins BioPharma Product Testing
Click here to watch this on-demand webinar
The Division of Pharmacy Professional Development at the University of Wisconsin and Eurofins BioPharma Product Testing are proud to bring you this live webinar.