Services
Secure Scalable Supply of Critical Assay Proteins for Diagnostic R&D
Supporting your transition to commercial IVD production with consistently high-quality complex diagnostic antigens and enzymes manufactured under robust quality management systems
Learn moreRecombinant Expression Tailored for Difficult Targets and Reliable Scale-up
Our custom expression platform directly addresses the primary host limitations in early-to-mid stage assay development:
- Inclusion Bodies & Solubility Challenges
- Requirement for Eukaryotic Processing & Glycosylation
- Scale-up Reoptimization Bottlenecks
Benefits & Features
Our specialized EntoEngine® genetics and scalable biomanufacturing provide the exact biological tools your development team needs to express hard-to-produce targets that aren’t available anywhere else.
Whether you need recombinant antigens or enzymes, we provide the reliable protein materials required for your assays, seamlessly integrating into your design controls and supplier qualification frameworks.
Batch Reproducibility & Traceability
Secure a reliable, high-quality supply of your target protein, produced through SOP-governed operations, rigorous quality controls, and end-to-end traceability through our eQMS.
Flexible & Rapid Scaling
Accelerate your assay validation timelines by transitioning seamlessly from initial discovery sequences to gram-scale pilot lots in record time.
Cost-Effective Alternatives to CHO/HEK
Eliminate the steep costs and lengthy development cycles associated with traditional mammalian host platforms during the crucial assay optimization phase.
Quality Manufacturing
Built-in Excellence
At Instar 1.0, manufacturing is executed in segregated ISO Class 7 and 8 Cleanrooms and supported by rigorous environmental monitoring programs.
On track to obtain ISO 13485:2016 Certification, we are expanding our QMS to encompass ISO-specific requirements and GMP principles.
Case Study
From Sequence To Scale In Seven Months: The EntoEngine® Achieves Rapid Commercial Scale With Stable Strains
Learn MoreCase Study
Manufacturing Glycosylated Erythropoietin Without 𝛼1,3-Fucosylation Using the EntoEngine®
Learn MoreDownload the tech brief
Learn how our EntoEngine® can produce your antigen or enzyme and resolve supply chain constraints.