Webinars

    Biopharmaceutical Process Characterization

    Biopharmaceutical Process Characterization

    06.11.20

    Thursday, June 11th, 2020 | 10:00 AM ET

    Laboratory scale process characterization provides in-depth process understanding and documentation of a manufacturing process needed to establish critical product and process parameters, determine proven acceptable control ranges and minimize the risk of manufacturing failures at production scale. Here we present process development and characterization strategies at Samsung Biologics required to support commercial scale manufacture of antibody therapeutics. The webinar will discuss approaches to demonstrate process understanding needed to develop a robust and scalable manufacturing process to support successful GMP manufacture of biologics.
     
    SPEAKERS:

    Kenneth Dawson Green
    PhD / Senior Director, Manufacturing Science & Technology Team
     
    Thomas Rene Gervais
    PhD / Director, Manufacturing Science & Technology Team - Downstream


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    Pharma Packaging Considerations for Radiation Processing

    Pharma Packaging Considerations for Radiation Processing

    05.20.20

    Plus, a discussion on the new container closure integrity testing: Mass Extraction
     

    NOW AVAILABLE ON-DEMAND

     

    This webinar is designed to build your foundational knowledge of pharma packaging. The type and method of packaging is an important consideration for radiation processing using gamma and electron beam. This webinar discusses how product packaging and presentation (density, weight and product orientation) can affect routine processing. Examples will be presented about how certain considerations are taken into account when developing the product packaging to ensure an effective radiation sterilization process. The webinar will also cover mass extraction, a relatively new container closure integrity test which is included on the USP 1207 list of approved deterministic CCIT test methods. You will learn the basic methodology behind a mass extraction test, the advantages of mass extraction testing over other CCI methods, and how the test is performed.

     

    Speakers:

     

    Jennifer Gygi  

    Validation Specialist III / Technical Consulting Manager, Nelson Labs

     

    John Schlecht 

    VP, Radiation Technical Services, Sterigenics 


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    PRIME: A Knowledge-based Assessment Tool to Classify Pharmaceutical Processes

    PRIME: A Knowledge-based Assessment Tool to Classify Pharmaceutical Processes

    05.11.20

    NOW AVAILABLE ON-DEMAND

    The manufacturing of API is a long and complex process. The comparison between the different processes is not easy since the chemical structures vary and therefore the compounds physical properties also change. 

     

    In this webinar we will be presenting the tool we developed to be able to take advantage of 60 years of experience in developing API process. The use of this tool allows us to develop our clients' projects using a Development by Design approach and to better manage the expectations of different outputs at different lifecycle stages of the processes. This follows a structured approach which allows for a faster process development. 

     

    What can you learn from this webinar?

    • How we score processes
    • How the knowledge can be used to develop an API manufacturing by design
    • How we can speed-up the process development.

    Join this webinar where our speakers will share their views on this new tool that is able to accelerate the development process.

     

    Speakers:

     

    Rui Loureiro 

    Director, R&D Process Chemistry Development

    Hovione

     

    Filipe Ataíde 

    Senior Scientist, R&D Process Chemistry Development

    Hovione


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    ICH Stability Testing and Method Development

    ICH Stability Testing and Method Development

    04.22.20

    NOW AVAILABLE ON-DEMAND

    Stability testing is a vital part of product development and is conducted throughout a product’s life cycle. Stability is part of a biotherapeutic’s quality target product profile, and results help analysts understand how critical quality attributes (CQAs) of both drug substances and products are influenced under specific conditions of temperature, relative humidity (RH), light, storage, pH, and other factors. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO and or other agencies. This presentation will provide a brief overview of the ICH guidelines for Stability testing, as well as aspects of analytical method development.

    Speaker:
     

    Shiri Hechter

    Chemistry Senior Lab Operation Manager, M.Sc., ASQ CQA and CSSGB

    Nelson Labs Fairfield
     

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    New Horizons in Formulation

    New Horizons in Formulation

    03.24.20

    NOW AVAILABLE ON-DEMAND

    A Revolution in the Production of Mono-Dispersed Controlled Release Microparticles

    Are existing technologies fit-for-purpose in terms of quality, control, efficiency and throughput volumes for manufacturing complex 21st century therapeutics? A new generation of proven, energy efficient, high volume membrane emulsification equipment, promises to be a game-changer for contract pharma. In this webinar you will learn:

    • The enhanced therapeutic performance potential for emulsions, double emulsions and encapsulated particles in pharma applications with improved mono-dispersity;
    • Why membrane emulsification offers significant advantages over both traditional homogenization and microfluidic processing; and
    • Through specific case studies, how this new technology can significantly reduce or eliminate downstream processing steps with significant manufacturing savings.
    Speakers:
     
    Dr. James D. Oxley, Ph.D
    Southwest Research Institute (SwRI) in San Antonio, TX, USA.
     
    Sam Trotter MSc
    Operations Manager at Micropore Technologies Ltd.


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    Serialization 2.0 – What’s Next?

    Serialization 2.0 – What’s Next?

    02.12.20

    NOW AVAILABLE ON-DEMAND

    The road to serialization has been long and arduous for the pharmaceutical industry. Yet, there are still many hurdles to overcome in the next few years—saleable returns, line aggregation and interoperable data exchange just to name a few.

    Additionally, industry experts now realize that serialization alone will not solve the ever-increasing global threat of counterfeited and diverted pharmaceutical products. The investments made to date on serialization are staggering and pharmaceutical companies are now looking to leverage these efforts to more effectively fight their supply chain and compliance issues.

    Join us as we discuss the future of the pharmaceutical supply chain and review innovative technologies that will not only get us to the 2023 DSCSA deadline, but are changing the landscape for brand, product and consumer protection.

    In this webinar we will discuss:

    • Saleable Returns and VRS
    • Secure tracking at the package level, including aggregation
    • Why your drug distribution channel is still not safe
    • Augmenting existing serialization solutions with innovative technologies
    • Leveraging existing package labeling to fight supply chain threats
    • Cost-effective solutions to prevent counterfeiting and diversion
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     Designing Auto-Injectors for Multiple Drug Viscosities

    Designing Auto-Injectors for Multiple Drug Viscosities

    11.26.19

    NOW AVAILABLE ON-DEMAND

    The global injectable drug delivery market and, more specifically, the auto-injector market is booming.  That growth is predicted to continue skyrocketing through the next decade.  With such a huge market in play, and given the range of physical properties of drugs and biologics being administered via auto-injectors, it is crucial for pharma and biopharma industry OEMs to optimize device designs to be as adaptable, and thereby as cost-effective, as possible.  Learn how to effectively partner with contract manufacturers and what design support they readily provide to you and your peers.

    SPEAKER: Dave Philbrick

    Dave Philbrick is Business Development Manager & Lead Product Engineer for Economy Spring, an MW Industries Company. For more than 38 years he has been involved in supporting new product development for medical instrumentation & drug delivery systems for Medical / Pharma OEM’s. He is a specialist in metal component development, design and integration.


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    Microbiological Control in a Pharmaceutical Manufacturing Environment

    Microbiological Control in a Pharmaceutical Manufacturing Environment

    10.29.19

    NOW AVAILABLE ON-DEMAND

    Part 1: Microbiological environmental monitoring data and establishment of alert and action levels
    This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data. We will review microbiological trending and how it can assist in understanding what is significant in each particular situation. The discussion will cover how the analysis of this trended data enables a company to establish alert and action levels as methods for determining these levels.

    Part 2: Pharmaceutical Environments Cleaning Validation Programs and Associated Disinfectant Studies
    We will review cleaning validation protocols, methods, and procedures to evaluate and define a robust program to protect your products, personnel, and equipment. We will discuss correlating disinfectant validations with the trending of routine-environmental monitoring data to establish a compliant program in a cleanroom environment.


    Part 3: Water Quality; Water Impurities, Purification Methods, Validation, and Process Controls
    Water is perhaps the most extensively used raw material in pharmaceutical manufacturing. Its use as an inactive ingredient, active pharmaceutical ingredient (API), analytical reagent, and even as a solvent in cleaning processes, leads to potential product and environmental contamination from residual water impurities. This presentation addresses the removal and control of microbiological and chemical impurities in a quality water system.


    Speakers:
    Martell Winters - Director- Scientific Competency
    Danina Rinaldi - Laboratory Technical Services Manager
    Paul Littley - Consulting Manager


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    Designing an End-to-End Sterility Assurance Program

    Designing an End-to-End Sterility Assurance Program

    07.25.19

    NOW AVAILABLE ON-DEMAND

    Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process. There is some recent movement in the health care industry regarding the term End-to-End Sterility Assurance, along with a document being written through AAMI to provide guidance on the topic. Effective sterility assurance includes extensive collaboration with parties across the product life cycle. In the webinar we will address the various aspects of sterility assurance and provide guidance on establishing a complete program.

    Speakers:
    Martell Winters - Director of Scientific Competency, Nelson Labs
    Wendy Wangsgard, PhD - Senior Scientist, Nelson Labs


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    Stability Testing as a Quality Control Measure

    Stability Testing as a Quality Control Measure

    06.25.19

    NOW AVAILABLE ON-DEMAND

    Optimizing the Process throughout the Product Lifecycle

    Assessing a compound’s stability is a complex and lengthy process with objectives varying by the development phase. A poorly designed stability study can cause delays that extend to years, create significant budget overruns and even result in product failure. Thus, stability testing requires scientific expertise and very specialized experience in order to minimize development costs and avoid severe consequences. This webinar will discuss the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.

    SPEAKER:
    Guoqiang (Gary) Dong, PhD
    Executive Director of Analytical Services of CMC
    Frontage Laboratories


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    Terminal Sterilization or Aseptic Assembly? Consider all options for your Pharma product.

    Terminal Sterilization or Aseptic Assembly? Consider all options for your Pharma product.

    05.21.19

    NOW AVAILABLE ON-DEMAND

    Regulation is clear that, whenever possible, products intended to be sterile should be terminally sterilized in their final container. Only if terminal sterilization is not possible, filtration or aseptic assembly should be applied. This webinar will focus on elements to evaluate prior to selecting aseptic assembly for the manufacturing of sterile drug products. Participants will learn about various mitigation possibilities for the use of terminal sterilization with gamma radiation or ethylene oxide. Understanding the fundamental differences between aseptic assembly and terminal sterilization is a critical factor in overall patient safety.

    SPEAKER:
    Annick Gillet, Technical Director EO Pharma


    Register Now!