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Trends in Process Analytical Technology: Present State in Bioprocessing

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New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins

Part of the book series: Advances in Biochemical Engineering/Biotechnology ((ABE,volume 165))

Abstract

Process analytical technology (PAT), the regulatory initiative for incorporating quality in pharmaceutical manufacturing, is an area of intense research and interest. If PAT is effectively applied to bioprocesses, this can increase process understanding and control, and mitigate the risk from substandard drug products to both manufacturer and patient. To optimize the benefits of PAT, the entire PAT framework must be considered and each elements of PAT must be carefully selected, including sensor and analytical technology, data analysis techniques, control strategies and algorithms, and process optimization routines. This chapter discusses the current state of PAT in the biopharmaceutical industry, including several case studies demonstrating the degree of maturity of various PAT tools.

Hierarchy of QbD components

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Abbreviations

ANN:

Artificial neural network

API:

Active pharmaceutical ingredient

CIP:

Cleaning in place

CPP:

Critical process parameter

CQA:

Critical quality attribute

EMA:

European Medicine Agency

FDA:

U.S. Food and Drug Administration

HPLC:

High-performance liquid chromatography

ICH:

International Council for Harmonisation

mAb:

Monoclonal antibody

MIR:

Mid-infrared

MOC:

Material of construction

MPC:

Model predictive control

MSPC:

Multivariate statistical process control

MVDA:

Multivariate data analysis

NIR:

Near infrared

OUR:

Oxygen uptake rate

PCV:

Packed cell volume

PHC:

Personalized healthcare

QbD:

Quality by Design

QC:

Quality control

ROI:

Return on investment

RQ:

Respiratory quotient

RVR:

Relevance vector regression

SVR:

Support vector regression

VCD:

Viable cell density

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Acknowledgements

Part of the explorations presented here was a collaborative work together with 4Tune Engineering Ltd., and YourEncore. We gratefully acknowledge this support.

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Authors and Affiliations

  1. Roche Pharma Technical Operations – Biologics Manufacturing, Nonnenwald 2, 82377, Penzberg, Germany

    Marco Jenzsch

  2. Roche Pharma Technical Operations – Biologics Analytical Development Europe, Grenzacherstrasse 124, 4070, Basel, Switzerland

    Christian Bell

  3. Roche Pharma Technical Operations – Bioprocess Development Europe, Nonnenwald 2, 82377, Penzberg, Germany

    Stefan Buziol

  4. Roche Pharma Technical Operations – Biologics Analytical Development Europe, Nonnenwald 2, 82377, Penzberg, Germany

    Felix Kepert & Harald Wegele

  5. Roche Pharma Technical Operations – Biologics Global Manufacturing Science and Technology, Sandhofer Strasse 116, 68305, Mannheim, Germany

    Christian Hakemeyer

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  1. Marco Jenzsch
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Correspondence to Marco Jenzsch .

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  1. Sutro Biopharma Inc., San Francisco, CA, USA

    Bob Kiss

  2. Lonza, Basel, Switzerland

    Uwe Gottschalk

  3. Solothurn Manufacturing Facility, Biogen International GmbH, Luterbach, Switzerland

    Michael Pohlscheidt

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Jenzsch, M., Bell, C., Buziol, S., Kepert, F., Wegele, H., Hakemeyer, C. (2017). Trends in Process Analytical Technology: Present State in Bioprocessing. In: Kiss, B., Gottschalk, U., Pohlscheidt, M. (eds) New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins. Advances in Biochemical Engineering/Biotechnology, vol 165. Springer, Cham. https://doi.org/10.1007/10_2017_18

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