Abstract
Transmissible spongiform encephalopathy (TSE) agents, or prions as they are commonly referred to,
are a significant concern to the biologicals and biotechnology industries. With the BSE epidemic in
the UK in the nineteen eighties and the subsequent demonstration that the BSE prion has crossed the
species barrier and manifested itself in humans as variant Creutzfeldt-Jakob Disease (vCJD), risk
assessment when ruminant and specifically, bovine-sourced materials are used in the manufacture of
biopharmaceuticals is imperative. The altered tissue tropism of vCJD (localized in the lymphoid
tissues rather than the central nervous system), combined with the resilience of prions to most
inactivating agents, the extended incubation period (measured in years and decades rather than days
and months) and lack of validated prion detection assays for detection during the subclinical phase
of the disease have escalated the stakes for biotherapeutics from a TSE-safety standpoint.
There is no evidence to date that BSE has been transmitted by the use of ruminant-derived raw
materials during the manufacture of biopharmaceuticals. Whether blood and blood products transmit
prions is not unequivocal; nevertheless, researchers have demonstrated that blood could potentially
transmit prion infections in experimental animals. While every effort is being made to move away
from ruminant-sourced products such as enzymes, media additives and serum during biopharmaceuticals
manufacturing, these products cannot be totally excluded from many manufacturing processes. As BSE
continues to be a pandemic problem, in the interests of protecting public health and safety, the
potential risks of exposure to these agents must be minimized.
Scope
This Report offers valuable insight into the challenges encountered during manufacture of
plasma-derived products or ruminant-sourced raw materials employed in biopharmaceutical
manufacturing. The Report highlights the importance of risk management in order to ensure
biopharmaceutical safety from a prion-safety standpoint. In addition, this Report provides
information on the nature of prions based upon currently available knowledge, and covers
specifically the issues that need to be addressed in biopharmaceuticals manufacturing in order to
produce a safe and efficacious product and comply with the regulations.
Key Reasons to Buy
- Get an up-to-date perspective on TSE agents (prions) through a state-of-the-art overview of
issues related to prions and their relevance for biopharmaceutical safety.
- Discover the implications for medicinal products that either directly use bovine-sourced
products or are supplemented with bovine products during the various stages of manufacturing and
downstream processing.
- Understand the crucial contribution of controlled sourcing through a comprehensive look at the
various production process control approaches and their relevance in strategic and long-range
planning.
- Gain insight into available detection methodologies via a complete review of the various prion
detection methods used in biopharmaceutical manufacturing process validation and research studies.
- Obtain information on manufacturing methods with potential for prion clearance through a
discussion of various industry-validated and innovative technologies.
- Recognize the pivotal role of risk minimization and management from a prion safety standpoint.
- Learn about process validation (clearance evaluation) study design for prion clearance and
pitfalls to avoid with coverage of the issues that need to be addressed.
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