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Manufacturing of Highly Potent Drug Product in a Clinical Multi-Product Aseptic Facility and Transfer of Principles to Antibiotic Drug Product

  • Karoline Bechtold-Peters
  • Silke Mohl
Chapter
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 38)

Abstract

The manufacturing of highly potent drug products in a multi-product aseptic facility and the transfer of principles to antibiotic drug products is certainly a challenging field. The authors have successfully implemented this in a clinical manufacturing unit and have been able to explain the rationales to regulating authorities. The assumption of a physically imaginable worst-case approach considering various risk-reducing factors based on scientific considerations is key. Several examples of design as well as of operational features to avoid cross-contamination are described. The authors conclude that at least clinical facilities should be able to manufacture the increasingly higher potent drugs of the future in multi-product units. There is no scientific rationale why this should not also be amenable for commercial facilities from a product risk perspective.

Keywords

High potent drugs Aseptic drug product facility ADC Multi-product Cleaning validation 

Terms

ADE

Acceptable daily exposure

CFU

Colony forming units

OEL

Operational exposure level

AAC

Antibody–antibiotic conjugate

ADC

Antibody–drug conjugate

ADE = PDE

 Acceptable or permitted daily exposure

CIP

Cleaning in place

CIP/SIP/DIP

Cleaning in place, sterilization in place, drying in place

ELISA

Enzyme-linked immunosorbent assay

EU

Endotoxin unit

LTP

Liquid transfer port

MAC

Maximum allowable carryover

MBS

Minimum batch size

MDD

Maximum daily dose of the subsequent product

ppb

Parts per billion

ppm

Parts per million

RTP

Rapid transfer port

STD

Smallest therapeutic dose

TDC

Thiomab-drug conjugate

VHP

Vaporized hydrogen peroxide

WIP

Washing in place

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  1. 1.Novartis Pharma AGBaselSwitzerland
  2. 2.F. Hoffmann-La Roche LtdBaselSwitzerland

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