Plants for the Fractionation of Human Blood Plasma
Proteins are macromolecules consisting of amino acids and forming the main cell building blocks of living organisms.
Proteins used for medical purposes are obtained, among others, from human blood plasma. Several emergency medicine drugs with proteins as pharmaceutical substances, e.g. for treatment of coagulation disturbances, immune defects and wound healing disturbances are obtained from this valuable starting material.
Obtaining proteins from blood plasma is carried out via the complex process of plasma fractionation and purification. The required cleanliness and unique characteristics of fractionation products make not only very high demands on the organisation of the production processes but also require a complete proving chain, allowing retraceability of the way of blood plasma from the donator to the finished dosage form. Compliances with these requirements is subject to international controls.
High demands towards automation, information technology, building and clean room technology, and planning according to the requirements of Good Manufacturing Practice (GMP) presuppose interdisciplinary planning teams and application of continuously further developed tools and processes for plant design.
Linde-KCA-Dresden belongs to those engineering and contracting companies that may refer to this qualification.
Selected References
Example 1
Plant for filling of large volume parenterals
Client:
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Location:
Vienna / Austria
Type of plant:
New plant for filling of blood plasma fractionation products (isolation technology)
Scope of work: conceptual engineering basic engineering detail engineering qualification utility piping |
Planning period:
2002 - 2004
Example 2
Plant for fractionation of human blood plasma
Client:
Octapharma AB
Location:
Stockholm / Sweden
Type of order:
Revamp and extension of plants for the fractionation of human blood plasma, for the production and for the finishing of blood plasma products
Products:
Gamma-Globulin, Albumin and Blood Coagulation Products
Scope of work:
Master planning
Planning period:
2003 and 2006/07
Example 3
Plant for the fractionation of human blood plasma
Client:
Biotest Pharma GmbH
Location:
Dreieich / Germany
Type of order:
New plants for the fractionation of blood plasma and the production of blood coagulation factors
Products:
Immunglobuline, human albumine and blood coagulation products
Scope of work: Project management and controlling Engineering Site coordination Controlling Qualification |
Planning period:
2001 - 2004
Example 4
Plant for the fractionation of human blood plasma
Client:
Aventis Behring GmbH
Location:
planned for Marburg/Germany
Type of plant:
Plant for the fractionation of human blood plasma
Products:
Basic fractions of human blood plasma and products of down stream processing
Scope of work:
Concept and basic engineering for process, architecture, civil engineering, infrastructure, IT
Planning period:
2001 - 2002
Example 5
Blood plasma fractionation plant
Client:
Bayer Biologicals s.r.I.
Standort:
Rosia / Italy
Type of order: Plant concept ,Grass roots‘ plant New buildings: fractionation, warehouse and QC Revamp utilities building |
Products:
Bulk intermediates
Scope of work: Conceptual design based on Bayer draft Basic: site development, fractionation, warehouse, utilities Detail: QC, administration |
Planning period:
1998
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Further references
Plant concept for a blood plasma plant
Reconstruction and extension of a blood plasma fractionation plant in compliance with GMP as well as filling of fractionation products for Octapharma Pharmazeutika Produktionsgesellschaft m.b.H. in Vienna (Austria),
concept design including layout planning in 2002 and first stages of realization until 2004
