MANUFACTURING
Our laboratory and pilot facilities enable the custom manufacturing of plasma protein candidates and the optimization of existing proteins – providing flexibility from early-stage research through to GMP-compliant production.
Service Scope:
– Production of high-purity material in research-grade quality.
Purpose:
– Custom-tailored solutions for diverse projects, utilizing versatile multi-use equipment.
Scaling:
– Flexibly adaptable to research requirements.
Quality:
– research standard
Service Scope:
– Seamless scaling based on laboratory-scale development & dedicated test runs on pilot equipment prior to full-scale GMP production.
Purpose:
– Tox campaigns & utilization of both single-use and multi-use equipment.
Scaling:
– Up to 300 liters
Quality:
– oGMP-like production processes, strictly governed by PreviPharma’s comprehensive Quality Management System
Service Scope:
– Manufacturing of material for GLP toxicology studies and clinical trials, Production up to Drug Substance (DS) stage & fill & Finish services through qualified strategic partners.
Purpose:
– Use of single-use systems in a validated environment.
Scaling:
– 100 L & future expansion projected up to 2,000 liters.
Quality:
– Fully GMP-compliant production, recognized according to FDA and EMA standards.
From research to GMP production: flexible, scalable, and regulatory-compliant for a seamless transfer into industrial application.
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We would be happy to provide you with further information and discuss the possibilities for cooperations with you.
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