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Accelerating Biomanufacturing by Modelling

Sep 15 - Sep 18, 2019
Clausthal-Zellerfeld, Germany

  • Education
  • Europe

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Program Highlights
The course takes place at Clausthal University of Technology.

Overview

Innovative biologics, including cell therapeutics, VLPs, exosomes, recombinant proteins, peptides etc. seem to substitute monoclonal antibodies as the main therapeutic entities in manufacturing over the next decades.  This molecular variety causes a growing need for a general change of methods as well as mindset in the process development stage as there are no platform processes available like for mabs.

Moreover, market competitiveness demands hyper-intensified processes, including accelerated decisions toward batch- or continuous operation of dedicated modular plant concepts. This indicates gaps in process comprehension, when operation windows need to be run at the edges of optimization.

In this trainings course potential methods are demonstrated for possible solutions throughout the workflow from process development over piloting towards manufacturing operation from process engineering point of view and experience. Especially, the state-of-art for modelling in biologics manufacturing is assessed, clarifying differences and application of statistical, rigorous physical-chemical based models as well as cost modelling. “Digital-twins” are described and efforts vs. benefits for new applications exemplified including the regulatory demanded QbD-(quality by design) and PAT-(process analytical technology)-approaches towards digitalization or industry 4.0 based on advanced process control strategies. Finally, an analysis of obstacles and possible solutions for any successful and efficient industrialization of innovative methods from process development over piloting towards manufacturing, operation, robustness, and analysis results in some recommendations. A central question is exemplified: Under the mindset of QbD and PAT demanded by authorities since 2004, could any biologics manufacturing process be regulatory approved without being modelled by a digital-twin as part of the filing documentation?

Scientists and technicians, involved in process development, should be familiar with the way, how Downstream Processing Sequences are efficiently transferred from preparative into pilot- and production-scale. Profound theoretical and experimental knowledge as well as comprehension of newest design methods will help to meet the time pressure and enormous experimental efforts in daily project work.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Day 4
  • Sunday, 15 September 2019

    19:00
    Check-In and Dinner in Restaurant 'Pixhaier Mühle'


    20:00
    Networking Event: Oberharzer Wasserregal and Mining History

  • Monday, 16 September 2019

    8:30
    Welcome and Introduction


    9:00
    Introduction Biomanufacturing Modelling


    10:00
    Fermentation Modelling


    11:15
    Lunch Break

    12:00
    Institute - Guided Tour


    13:00
    Chromatography Modelling


    13:45
    Liquid-Liquid-Extraction (LL-Extraction) Modelling


    14:30
    Membranes Modeling


    15:30
    Experiments in the Laboratoryn
    Part I: Fermentation, Membranes, Chromatography, LL-Extraction


    18:30
    Networking Event: Guided Tour Mining Museum and Dinner


    22:30
    Return to Hotel 'Pixhaier Mühle'

  • Tuesday, 17 September 2019

    8:30
    Introduction into Fundamentals of Modeling and Simulation Software


    9:15
    Experimental Model Parameter Determination


    10:15
    Crystallization/Precipitation Modelling


    11:15
    Lunch Break

    12:00
    Experiments in the Laboratory
    Part II: Cryst./Precip, LL-Extraction, Lyophilization, PAT with PLS/PCA


    16:30
    Networking Event: Guided Tour and Dinner in Goslar


    20:00 - 24:00
    Midnight Session at Hotel 'Pixhauer Mühle': Simulation Tutorials Fermentation, Chromatography, Membranes, Extraction, Lyophilization, 'Clausthaler-Mitternachtsschrei'

     

  • Wednesday, 18 September 2019

    8:30
    Fundamentals QbD and PAT


    9:15
    Cost Modelling


    10:15
    GMP Regulatory Continuous Bioprocessing (CBP)


    11:15
    Lunch Break

    12:00
    Quality by Design (QbD) - Technology in Total Process Design


    12:45
    Lyophilization


    13:30
    CBP-Industrialization


    14:15
    Process Analytical Technology (PAT) and Bioanalytics, Regulatory


    15:00
    Discussion, Q&A


    15:30
    End of Course

Trainers

Jochen Strube
Jochen Strube
Clausthal University of Technology - Institute for Separation and Process Technology

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon completion of the course participants will be

    • able to apply modern Upstream and Downstream Processing and process design methods in the daily project work
    • familiar with handling of fermentation, membrane, extraction, crystallization / precipitation, chromatography and lyophilization equipment
    • able, to evaluate platform-technologies and the consequences of the 'Quality-by-Design'(QbD) approach incl. 'Process Analytical Technology' (PAT) initiative from 'American Food and Drug Administration' (FDA)
    • in the position to propose experiments for design of USP and DSP unit operations
    • able to make a scale-up transfer of total processes well informed about possibilities and limitations of process design of USP and DSP processes by aid of simulations
  • Who Should Attend

    Who Should Attend

    Scientists and laboratory technicians involved in process development and / or manufacturing. Besides some basic knowledge in computer handling no previous knowledge will be assumed.
  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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Clausthal University of Technology

Leibnitzstrasse 15
Clausthal-Zellerfeld, Germany
Phone: +49 53 23 22 15

  • Accommodations

    Waldhotel 'Die Pixhaier Mühle'
    An der Pixhaier Mühle 1
    38678 Clausthal-Zellerfeld
    Germany
    Hotel Website


    Transfers are offered and organized TU Clausthal.
    • from/to Göttingen ICE Main Station(on first Course Day and after Course End)
    • in Clausthal between Hotel "Pixaier Mühle" and course locations

    In the Mensa of the University opportunity for lucnh is given (self-pay basis)

  • Amenities

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Registration Fees

Regular Price
Registration Type Price
All Participants €2.750

All fees given in Euro and excluding VAT

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

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