About This Course

NSF International has upgraded this course for 2019, including relocating it to a biotech facility in Dublin. By interacting with our experts and taking part in plant tours, you gain insight into internationally recognized current Good Manufacturing Practice (cGMP) expectations concerning a range of bioprocesses including:

  • Seed/cell banking
  • Serial and bulk cultivation
  • Harvesting
  • Centrifugation
  • Viral inactivation
  • Chromatography
  • Ultrafiltration
  • Protein concentration

Our biotech training course discusses and interprets the cGMP requirements for each step involved with process development, validation, control, auditing, and effective quality assurance (QA) and quality control (QC). We run process simulations and have detailed discussions that promote understanding about risk assessment, deviation investigation and batch dispositioning. This course also provides a unique insight into assuring GMP for biological products when working alongside experts in the field across a complex process train.

NSF designed the course to give production, QA, QC and technical services staff detailed insight into the challenges of producing and testing biotech and biological pharma products. It allows delegates to appreciate the particular design, controls and monitoring required for ensuring consistent bioprocesses are executed right the first time. These disciplines are explained in terms of the resources needed for each of the key bioprocesses, key equipment and utilities, and commonly required critical process parameters.

The course also introduces best practices when manufacturing advanced therapy medicinal products (ATMPs), when choosing to contract out key process steps, and particular biotech concerns when formulating the finished product. As part of our course upgrade, we go into further detail about developing a QC strategy for biomolecular characterization and provide more in-depth, practical guidance on drug substance QC testing for batch dispositioning and stability testing purposes.

Utilizing guest speakers from the biotech facility, discussion groups, gemba walks and interactive plant tours, this course demonstrates how to perform a GMP audit of a biotech process/facility and is a unique introduction to this growing sector of the pharma industry.

Key Learning Objectives

On completion of this course, delegates will know and understand:

  • The common stages in the mammalian and bacterial bioproduction processes
  • How to verify the effectiveness of each bioprocess stage via online and offline monitoring and testing
  • The critical challenges associated with bioprocessing in terms of vulnerability, risk assessment and process control
  • How the pharma quality system must be designed around the requirements of the biomolecule
  • Audit bioprocesses, how they are designed and controlled, what key documentation is generated and how an effective product dispositioning system is set up (taking into account common process deviations or cGMP deficiencies gleaned from real-life experience in the field)

The course is designed to support trainee EU Qualified Persons as part of their QP application or as a valuable, highly focused continuing professional development event.

Our biotech training helps delegates learn how to:

  • Identify the key differences in bioprocessing compared to chemical synthesis of small molecule drug substances
  • Feel confident in making the right decisions at the right time with the right information when faced with the common challenges or GMP deviations associated with bioprocessing of drug substances
  • Identify what should appear in batch documentation associated with the key bioprocessing steps
  • Generate a risk-based, targeted audit agenda and be aware of the key requirements in the EudraLex GMP Volume 4, Annex 2

Delegates also become better equipped at adding value to commissioning, qualification, validation, production, operational QA and GMP auditing on-site and across fragmented global supply chains.

Course Outline

The subject matter this course covers includes:

  • The key design, controls and monitors associated with the common biotech process steps
  • The basic science and typical process controls associated with producing a high quality biological or biotech drug substance
  • An introduction to how quality is assured across the bioprocess and the insights/limitation of QC testing
  • The benefits and pitfalls of subcontracting key steps in the bioprocess
  • A summary of current hot topics in this field in terms of regulatory censure, GMP observations and trends
  • How to audit a biological or biotech facility
  • Guidance on the key concerns when acting as an EU QP or QA/production/technical services professional in this field

Key sessions include:

  • Access to a biotech facility via detailed plant tours and demonstrations, ensuring key learning objectives are met on plant
  • Three separate biotech plant tours (upstream processing, downstream processing and a mock audit of the facility)
  • Team exercises and discussion groups, including demonstrations and videos
  • Two industry expert guest speakers (new advances in bioprocessing and QC bioassay techniques)
  • Expert presentations on:
    • Major quality challenges
    • EudraLex GMP Volume 4, Annex 2
    • EU and U.S. regulatory framework and expectations
    • Design, control and monitoring of premises and utilities used in bioprocessing
    • Cell banks and seed lots
    • Starting materials, buffers and reagents
    • Cultivation and harvest
    • Purification
    • Control of transmissible infection
    • Cleaning validation
    • GMP auditing
    • Contracting out bioprocesses
    • Cold chain management
    • QC strategy and practice
    • Common GMP deviations and how to prevent them recurring
    • Regulatory GMP inspection and related hot topics
    • ATMPs
    • Biosimilars
    • Risk management and mitigation

Course Tutors

Roger Guest - Roger has held senior roles in R&D, manufacturing and QA with several blue-chip pharma and biotech companies. He has been responsible for the design and implementation of new sterile manufacturing facilities and has extensive experience in the development of IMPs and biologicals from formulation to manufacture.

John Johnson - Vice President at NSF, John has vast experience in preparing sites for regulatory GMP inspections, preparing or remodelling biopharma and steriles facilities, installing quality systems and helping companies embed the right culture for long-term sustainable growth. A passionate educator, John has a track record of improving service and margin to ensure perpetual GMP inspection readiness.