Large-scale Manufacturing
Large-scale Manufacturing using SmartEnzymes Enables Next Generation Biologics
The SmartEnzymes from Genovis have not only revolutionized analytical characterization workflows but can also be used in manufacturing of novel biologics.
The unique specificity of SmartEnzymes enables processing of biological drugs into novel homogenous formats with desired clinical properties. Genovis has a track record of supplying high quality enzymes at quantities needed for manufacturing scale to enable the next generation of biopharmaceuticals.
Quality First – The Right Quality for Your Application
The use of Genovis SmartEnzymes in bioprocess applications adds new quality requirements. To meet the increasing demands from customers in regulated environments, Genovis has developed enzyme formulations at high purity with documented quality.
- Low endotoxin and bioburden specification using pharmacopeia-validated methods
- Documented animal-free origin and manufacturing process
- Advanced QC methodology to demonstrate batch-to-batch consistency
Genovis BioProcess Grade Enzymes are produced under ISO9001:2015 certification.
Genovis Capabilities
Enzymes have the potential to speed up bioprocessing unit operations by acting fast and specific. Instead of genetically engineering for antibody fragments, standard operating procedures can be used with an addition of an enzyme step.
Genovis has capabilities of producing recombinant enzymes to meet the productivity and quality requirements for material used in clinical manufacturing. The quality of the material is denoted BioProcess grade* and the specification of such material is presented in Table 1. Custom formats, such as immobilized enzyme on resin, are available to enable large-scale applications.
Table 1. Quality Specification for BioProcess Grade Enzymes from Genovis.
| BioProcess Grade | |
| Physical purity | |
| Qualified QC methods | |
| Batch records with full traceability | |
| E. coli expression system | |
| Animal-free raw materials | |
| Animal-free manufacturing | |
| TSE/BSE statements | |
| Compendial assays for bioburden and endotoxin levels | |
| ISO 9001:2015 certification | |
| Custom formats available | |
| Shipping conditions | Shipped cold |
*BioProcess grade; Genovis does not manufacture or sell products known as Active Pharmaceutical Ingredients (APIs), nor does Genovis manufacture its products in compliance with all of the Current Good Manufacturing Practice regulations.
Unique Enzymes in Innovative Formats
The Genovis enzymes can be adapted in formats to better suit your bioprocess workflow. We provide the enzymes in solution, immobilized on resin or pre-packed in ready-to-process columns for easy integration. We actively collaborate with partners with extensive experience in providing chromatography resin for bulk applications.
BioProcess News from Genovis
Let Us Know How We Can Meet Your Requirements!
Genovis is dedicated to provide unique reagents of the highest quality. We work closely with our clients to identify what specific enzyme and quality will work best for you. Let us know about your project and how we best can assist you!
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