Final Fill Videos & On-Demand Webinars

April | 2017

• Presenter: Dr. Paul Beckett, Technology Manager Life Sciences, EMEA
• Abstract

  Overview of available TFF solutions for achieving high viscosity of monoclonal antibodies and plasma IgG, and strategies for reliable cycle-to-cycle cleaning.
  
  Current trends in the bioprocessing industry are driving mAb and plasma producers to formulate at higher protein concentrations. As a result, formulating using tangential flow filtration (TFF) may be limited in reaching these concentrations due to high pressures caused by highly viscous feed streams. Filtration devices used during processing have to be optimized in order to handle both high viscosity and pressures while maintaining high flux and excellent product recovery.
  
  In this webinar, we will review a recent study in which a family of filtration devices was evaluated to characterize the impact of membrane material and channel geometry on process performance and cleanability when working with high concentration feed streams. The results show the performance of each filtration device over multiple re-uses and presents a solution that can overcome process limitations due to high viscosity formulations.
  
  In this webinar you will learn:

  • Options to achieve higher concentration
  • Cleaning recommendations for TFF cassettes used in high viscosity feedstreams
  • Performance comparison between device design in TFF cassettes

Dec. | 2016

• Presenters: Jessica Shea, E&L Global Technical Services Manager, Provantage® Lab Services; Arun Prashanth, Manager for Validation Project Coordination team, Provantage® Lab Services, India
• Abstract

  Regulatory guidance requires a risk based extractables and leachables evaluation for drug manufacturing processes. Concerns about the increasing use of hybrid and fully single use systems in manufacturing processes and what they may contribute the bulk drug substance and final drug product has highlighted the need for thorough risk evaluations. Awareness of the risk each unit operation represents a strategy to deal with the risk is crucial.
  
  An outline of a manufacturing process will be presented along with each unit operations potential risk. This discussion will define an extractables testing strategy based upon the Biophorum Operations Group (BPOG) Extractables Protocol for the highest risk process step - sterilizing filtration in a point of use filling line application that is in direct contact with drug product. Analytical results from multiple methods for six model solvent streams will be shown: water, 0.5N NaOH, 0.1 M Phosphoric Acid, 50% Denatured Ethanol/ 50% Water mixture, 1% Polysorbate 80 and 5M NaCl; using time points of <30 minutes, 24 hours and 7 days. A comparison of the compounds identified by each method, solvent and time point will presented.  The extractables data from the sterilizing grade filter will be used to perform a patient safety evaluation for a typical process and a representative drug product.  The calculated extractables concentration per dose will be compared to the Permissible Daily Exposure (PDE) level for individual compounds.
   
  In this webinar you will learn:

  • Evaluation of the single-use manufacturing process and the highest risk application of final fill
  • Comparison of BPOG test condition and the USP draft of plastic components and systems used in pharmaceutical manufacturing
  • Patient safety evaluation for the final fill filter using data from testing following BPOG

Nov. | 2016

• Presenter: Michael Felo, Director Mobius Single-Use, Merck
• Abstract

  Single-Use systems, enabling faster more cost effective bio-pharma manufacturing, must also meet high quality parameters and standards while conducting component qualification, manufacturing operations, inprocess testing, and final product release.

  For single use systems, quality control during the manufacturing process is critical. In a traditional stainless-steel system, the end user has significant control over the design, construction, qualification and validation, and maintenance of the system. When implementing a single-use system, the supplier of the single use product takes responsibility for many of these functions from the user. It is therefore important that the single use supplier has established and follows a strong quality control system. This presentation will highlight the quality systems, processes, facilities, and personnel required to assure the performance, robustness, and sterility of single use systems.

  In this webinar you will learn:

  • The process used to qualify components, suppliers and sub-suppliers
  • Managing documentation control, change control, process particulate control, risk mitigation practices
  • See examples of Extractables Testing, Validation of MFG processes, MFG Controls, Sterilization Qualification, Realease Testing and Certification, Integrity Assurance

Nov. | 2016

• Presenter: Emily Peterson, Biomanufacturing Engineer, Merck
• Abstract

  Strategies to overcome key limitations and challenges such as higher molecular osmotic pressure and lower membrane permeability when customizing small molecule (3-10 kDa) TFF processing.

  Due to their higher osmotic pressures and mass transfer coefficients, small molecules in the range of 3 – 10 kDa, like insulin, often require unique processing conditions as compared to those of larger molecules. TFF processing strategies developed for larger molecule applications may not be appropriate and can lead to an increase in process variability and sub-optimal performance.

  This webinar explores:

  • The key limitations and challenges typically observed with small biological molecule TFF processing
  • Explains the strategies required for optimal success with your TFF step

Sept. | 2016

• Presenter: Dr. Alison Armstrong, Senior Director, Global Head of Field Development Services, Merck
• Abstract

  The requirements for the quality control (QC) of biological medicinal products are defined in guidance documents produced by regulatory agencies and international organisations such as EMA, US FDA, Japanese PMDA, ICH and WHO. Although these guidance documents are revised periodically, these revisions usually lag behind scientific advances and technical innovations.

  This webinar will describe a number of topics in the areas of cell line characterization and bulk harvest testing for contaminants where new technical innovations are occurring. The regulatory response to these developments will be discussed.

  Topics that will be covered include:

  • Current and new approaches to genetic stability and clonality determinations
  • New approaches to cell line identity testing
  • Spiroplasma testing
  • Evaluation of in vitro and in vivo assays for extraneous agent detection and replacement of in vivo assays
  • Recommendations for the virus evaluation of Investigational Medicinal Products (IMPs) from EMA and US FDA

Jan. | 2016

• Presenter: Kenneth Muzykewicz, Director of Membrane Process and Technology, Merck
• Abstract

  Changes happen. Suppliers go out of business. Plants consolidate. Drug product lifecycles exceed the lifecycles of the raw materials on which they’re reliant. We are committed to controlling, managing and communicating changes in the most stringent and highest quality manner to ensure your security of supply. In this webinar, Kenneth Muzykewicz will provide you with an overview of our change control process for critical raw materials within our filters.

  Join us for this webinar as we will focus on our:

  • Validation strategy & philosophy
  • Step by step approach to validation
  • Success criteria

  And learn how we:

  • Demonstrate no adverse effect on product performance
  • Define equivalence
  • Minimize the impact of change on your process

June | 2015

• Presenters: Jessica Shea, E&L Global Technical Services Manager, Provantage® Lab Services, Merck and Sue Walker, Market Development Manager, Final Fill, Merck
• Abstract

  The benefits of single use technologies are well documented. Risks associated with product loss, sterility and patient safety are magnified in the filling operation because of its closeness to the final product form and the patient. A systematic and thorough evaluation of the assembly manufacturing and filling process will identify risks that may be managed by the supplier and end user working together to create sound initial designs that are fit for the intended use. Managing regulatory and patient safety risks requires an accurate interpretation of regulatory requirements and the design of a step wise approach to identify and mitigate potentially toxic compounds that may leach from process components. This webinar will include remarks on key aspects of assembly manufacture and quality control; extractables and leachables, patient safety and implementation by the end user.

March | 2015

• Presenter: Sue Walker, Product Manager, Formulation and Final Fill Applications, Merck
• Abstract

  Particulates are a specific area of concern in formulation and final filling applications because of the proximity to the product in its final form. Single-use systems often come under more scrutiny than their stainless steel counterparts because the end user is no longer responsible for the manufacture of the system. With a collaborative effort between the end user and the supplier, as well as a robust particulate control strategy, single-use systems can be successfully used for this critical application. This webinar will discuss a proposed strategy for particulate control in single-use systems. Topics to be discussed will include control of raw materials, proper clean room controls and maintenance, operator training, in-process and final product inspection. With a thorough understanding and charaterization of the entire manufacturing process, single-use systems can be successfully used for final fill applications.

June | 2014

• Presenter: Sue Walker, Final Fill Product Manager, Merck
• Abstract

  There are significant benefits to single use technologies that have been well documented. However, there are also risks associated with their use that can include product loss, and questions around sterility assurance and product safety. These risks are magnified in the filling operation due to closeness to the final product in its final form. But there are considerations that can be used to mitigate risk during design, manufacture and use. During this webinar, we briefly review assembly design as well as other considerations such assembly manufacture and use, and supporting validation documentation.

Dec. | 2013

• Presenter: Randy Wilkins, Biosafety Field Marketing Manager, Merck
• Abstract

  Sterile filtration in your final filling process is a critical operation. There are multiple options in designing a sterile filtration process, for example using single stage vs. redundant filtration. Regulatory compliance and cost efficiency are challenges that require an understanding of the cost-benefits analysis. During this webinar, we will discuss a number of questions you may have as you design your sterile filtration process, looking to help you weigh the risks and benefits, and create a design that will best fit your needs.

Nov. | 2013

• Presenter: Sue Walker, Final Fill Market Development Manager, Merck
• Abstract

  The implementation of single-use technologies in the final filling process is steadily increasing. Single-use technologies can effectively meet the stringent requirements for this final process step with proper assembly design and integration. Part one of this two part webinar will discuss single-use assembly design considerations and practical applications for these assemblies in the final filling process. Particular attention will be given to the topics of flow path sterility and integrity as well as operational safety and efficiency. Part two of the webinar will focus on the filtration systems for final filling.