Disposable Bioreactors pp 1-31

Part of the Advances in Biochemical Engineering / Biotechnology book series (ABE, volume 115)

Disposable Bioreactors: Maturation into Pharmaceutical Glycoprotein Manufacturing

Abstract

Modern biopharmaceutical development is characterised by deep understanding of the structure activity relationship of biological drugs. Therefore, the production process has to be tailored more to the product requirements than to the existing equipment in a certain facility. In addition, the major challenges for the industry are to lower the high production costs of biologics and to shorten the overall development time. The flexibility for providing different modes of operation using disposable bioreactors in the same facility can fulfil these demands and support tailor-made processes.

Over the last 10 years, a huge and still increasing number of disposable bioreactors have entered the market. Bioreactor volumes of up to 2,000 L can be handled by using disposable bag systems. Each individual technology has been made available for different purposes up to the GMP compliant production of therapeutic drugs, even for market supply. This chapter summarises disposable technology development over the last decade by comparing the different technologies and showing trends and concepts for the future.

Keyword

Disposable Bioreactor Technologies Wave Bioreactors Disposable Stirred Bag Bioreactors Hollow Fibre Bioreactors Extractables Leachables GMP Production Pilot Plant Commercial Facility 

Abbreviations

ADCC

Antibody derived cytotoxicity

ASTM

American society for testing and materials

BPC

Bioprocess container

CAGR

Capacity annual growth rate

CAPEX

Capital expenditures

CHO

Chinese hamster ovary

CIP

Cleaning-in-place

CMO

Contract manufacturing organisation

COGs

Cost of goods

DO

Dissolved oxygen

EP

European pharmacopeia

EPO

Erythropoietin

EVA

Ethylene-vinyl-acetate

EVOH

Ethylene-vinyl-alcohol

FDA

Food and drug administration

GMP

Good manufacturing practice

ICH

International conference on harmonisation

IMP

Investigational medicinal product

ISO

International organisation of standardisation

ISTA

International safe transit association

JP

Japanese pharmacopeia

mAb

Monoclonal antibody

MCB

Master cell bank

MEM

Minimum essential medium

PAT

Process analytical technology

PE

Polyethylene

S.U.B.

Single use bioreactor

SBA

Summary basis of approval

SBBSlug

bubble bioreactor

SIP

Steam-in-place

USP

United states pharmacopeia

WCB

Working cell bank

WFI

Water for injection

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Copyright information

© Springer-Verlag Berlin Heidelberg 2009

Authors and Affiliations

  1. 1.ProBioGen AGBerlinGermany

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