How it works
Manufacturing
IntegoGen’s HCT/P contract manufacturing offers comprehensive end-to-end solutions for companies in regenerative medicine, biopharma, and healthcare. We empower our clients to deliver high-quality, compliant, and effective products to their markets with confidence.
Comprehensive HCT/P Product Development
Tissue Sourcing and Procurement
- Ethical and regulatory-compliant acquisition of donor tissues.
- Management of donor screening and testing to meet FDA and AATB guidelines.
Custom Product Design
- Tailored processing methods for amniotic tissues, placental tissues, and other HCT/Ps.
- Collaboration with clients to develop product formulations that meet specific clinical needs.
Regulatory Support
- Assistance with IND, IDE, and BLA submissions (as applicable).
- Guidance on FDA 21 CFR Part 1271 compliance.
Manufacturing and Processing Services
Cleanroom Manufacturing
ISO-certified, GMP-compliant facilities for aseptic processing.
Advanced Processing Techniques
Decellularization, lyophilization, or sterilization processes based on client requirements.
Batch and Lot Tracking
Rigorous documentation for full traceability.
Cleanroom Manufacturing
ISO-certified, GMP-compliant facilities for aseptic processing.
Advanced Processing Techniques
Decellularization, lyophilization, or sterilization processes based on client requirements.
Batch and Lot Tracking
Rigorous documentation for full traceability.
Private Labeling Services
Branding support for clients' proprietary products.
Small Batch to Large Scale Production
Capabilities to meet the demands of startups, mid-sized companies, and large enterprises.
Customization and Adaptability
Flexible manufacturing processes to accommodate changes in clinical or commercial requirements.
Private Labeling Services
Branding support for clients' proprietary products.
Small Batch to Large Scale Production
Capabilities to meet the demands of startups, mid-sized companies, and large enterprises.
Customization and Adaptability
Flexible manufacturing processes to accommodate changes in clinical or commercial requirements.
Quality Assurance and Compliance
Rigorous Quality Control Testing
- Sterility, biocompatibility, and functionality testing.
- Endotoxin and microbial contamination assessments.
Documentation and Certification
- Support for compliance audits and inspections.
- Creation of comprehensive product dossiers and Certificates of Analysis (COAs).
Third-Party Audits and Validation
Independent audits to validate processes and regulatory compliance.
Supply Chain Management
Distribution and Logistics Support
End-to-end distribution services, including product packaging, labeling, and shipping.
Inventory Management
Real-time monitoring of raw materials and finished products.
Research and Development Support
Preclinical Studies
Testing for safety, efficacy, and usability.
Innovation Services
Development of new tissue products and integration of emerging technologies.
Partnership and Strategic Collaboration
Turnkey Solutions
Full-service support from concept through commercialization.
Consultation Services
Expert advice on market positioning and commercialization strategies.
Onboarding for Client Teams
Training on HCT/P product handling, storage, and usage.
