Fractionation for Blood Plasma Products
Glatt Pharma+Biotech Engineering services for the fractionation of blood plasma and the manufacture of blood plasma products
Advanced lifesaving therapies by cleverly planned manufacturing processes for blood plasma products
Blood plasma products – such as Albumin, IgG Immunglobulin, Factor VIII or Factor IX – are essential to modern medicine, offering lifesaving treatments for a variety of conditions. The production of these products is highly specialized, requiring precision engineering and a deep understanding of biological processes. Glatt Process & Plant Engineering brings unparalleled expertise to this field, offering solutions that encompass every aspect of blood plasma product manufacturing.
Our focus is on innovation and quality. We design and implement processes for plasma fractionation that maximize yield and ensure the highest levels of purity. Our facilities are custom-built to support the unique requirements of plasma product manufacturing, from advanced separation technologies to stringent containment and sterilization systems. We recognize the critical nature of these products and the importance of compliance and safety in their production. Our team provides comprehensive support in navigating regulatory requirements, ensuring that your manufacturing processes meet all necessary standards for global distribution.
Sustainability is a cornerstone of our approach. We are committed to developing manufacturing solutions that not only meet the needs of today’s healthcare providers but do so in a way that is responsible and sustainable. With us, you have a partner who understands the complexities of blood plasma product production and is dedicated to advancing the field with innovative, reliable, and ethical solutions.
Our blood plasma fractionation projects
New blood plasma fractionation facility for CSL Behring, 2021, Germany
- Engineering of main process units in cooperation with GP Bideco GmbH including basic design for fractionation, buffers, CIP/SIP and further main process units, specifications and tender documents, detail engineering, supervision of implementation, commissioning and qualification (IQ/OQ)
- Scheduling for the overall project
New blood plasma fractionation facility for PlasmaGen Pvt Ltd., 2022, India
- Concept, Basic and Detail Design for overall site complex including plasma store, thawing, fractionation, purification, formulation, fill & finish, labs, utilities & energy supply
- Support ansd services for project implementation
- Products: Human blood plasma based therapeutics like immunoglobulin, human albumin and blood coagulation products
New blood plasma fractionation facility, 2020, India
- Design of process module with storage, fractionation and final goods manufacturing/packing including: Conceptual Design, FRA 1 (Facility Risk Assessment), equipment list with capacities, equipment orientation & integration, civil & architectural concepts, cGMP philosophy and PFD
- Human blood plasma; fractionation capacity 500,000 liters /year
New blood plasma fractionation facility, 2015, Germany
- Verification of concept design (process) + extended basis design for:
– fractionation process: buffer preparation, storage and distribution; precipitation vessels
– CIP units, clean utilities, clean room interior work
– tender documentation and specification sheets
– cost estimation for GIT’s scope of planning - Blood plasma derivates with capacities of 1.4 million liters blood plasma/year (5,200 liters blood plasma/batch)
New facility for the production of human blood plasma derivates for ROSPLASMA, 2010, Russia
- Turnkey project for th new production facility and set-up a network of modular plasma source establishments
- Blood plasma fractionation of 600,000 l/year to
– Albumin in 50 ml, 250 ml bottles with a capacity of 1,600,000 bottles/year
– IgG Immunglobulin in 50, 100, 200 ml bottles with a capacity of 440,000 bottles/year
– Factor VIII in 20 ml bottles with a capacity of 134,000 bottles/year
– Factor IX in 20 ml bottles with a capacity of 94,000 bottles/year
Further information on this topic and related topics can also be found in the following publications:
Link to: Glatt wins follow-up order for BioCampus MultiPilot
Copyright: ZVH Straubing
December 2023: Glatt wins follow-up order for BioCampus MultiPilot in the port of Straubing-Sand
Link to: Avoiding mistakes in cleanroom construction
Copyright: Vogel Communications Group
Published article: ‘Planning is everything. Avoiding mistakes in cleanroom construction’ PDF, Englisch
Link to: Moving the production of biopharmaceuticals to AsiaCopyright: Magzter Inc.
Published article: ‘How to move biopharmaceuticals productions smoothly and quickly into Asian markets’ PDF, Englisch
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- Copyright: Vogel Communications GroupCleanroom design. Doors, glazing, walls, fixturesAugust 22, 2024 - 3:14 pm
Copyright: Wiley-VCH GmbH
Copyright: Vogel Communications Group