At Elise Biopharma, we understand that bringing a product to market involves more than just scientific innovation—it requires reliable, high-quality manufacturing at every stage. Our Contract Manufacturing & OEM Services are designed to meet these needs by combining extensive bioprocess expertise with an unwavering commitment to compliance and customer satisfaction. From raw material sourcing through final packaging, we provide a truly end-to-end solution that can scale with your success.
Comprehensive Manufacturing Capabilities
- Raw Material Sourcing
- Global Supplier Network: We partner with vetted, trusted suppliers to secure critical inputs—ensuring consistency, traceability, and competitive pricing.
- Quality Verification: Inbound materials undergo rigorous testing to meet predetermined quality standards, reducing the risk of contamination or impurity.
- Formulation
- Customized Solutions: Whether you’re developing a clinical diagnostic reagent, therapeutic protein, or industrial enzyme, our team can optimize formulations for stability, shelf life, and performance.
- Liquid & Lyophilized Formats: We offer flexibility in final product forms, tailoring formulations to meet the specific demands of your application or market.
- Packaging
- Small & Large-Scale Packaging: From bench-scale vials to bulk containers for large production runs, our packaging options cater to diverse operational needs.
- Labeling & Kitting: We handle private labeling, barcoding, and kit assembly, ensuring a professional, fully compliant presentation for end users.
- Cell Banking
- Master & Working Cell Banks: Secure, well-characterized cell banks are crucial for long-term reliability of biologics. We store, track, and maintain your master and working cell banks under strictly controlled conditions.
- Regulatory-Ready Documentation: We meticulously document each step in the cell banking process, providing the detailed records essential for regulatory submissions and audits.
Scalable Production: From Bench to Commercial
- Bench-Scale
- Early Feasibility: For new or emerging products, our bench-scale capabilities allow you to refine methods and gather critical data before ramping up production.
- Flexible Batch Sizes: We accommodate small lots, essential for R&D projects and proof-of-concept trials.
- Pilot & Demo Scale
- Validation Runs: Pilot-scale production helps validate manufacturing processes, optimize yields, and confirm batch-to-batch consistency.
- Cost-Effective Testing: Demo-scale runs bridge the gap between lab work and commercial readiness, saving time and resources.
- Commercial Scale
- High-Volume Manufacturing: With extensive fermentor capacity, downstream processing suites, and automated packaging lines, we deliver efficient production for large-scale market supply.
- Global Distribution: Our streamlined logistics, combined with top-tier compliance, facilitate seamless shipping to worldwide destinations.
Compliance & Quality Standards
- ISO Certifications (13485 & 9001)
Our manufacturing facilities and quality management systems are certified to ISO standards, ensuring product reliability for medical device and general industrial applications alike. - FDA Registration
Elise Biopharma operates in accordance with FDA guidelines, meeting stringent U.S. regulatory requirements for safety, efficacy, and traceability. This status streamlines the path to market for products destined for the U.S. healthcare ecosystem. - OEM Partnerships for Third-Party IVD Manufacturers
We specialize in white-label and OEM manufacturing for diagnostics and medical device companies. Our collaborative approach ensures that each product aligns perfectly with your brand, specifications, and regulatory obligations.
Why Choose Elise Biopharma for Contract Manufacturing & OEM?
- End-to-End Expertise
By integrating raw material sourcing, formulation, production, and packaging under one roof, we reduce complexity, risk, and turnaround times—giving you a faster route to market. - Technical Excellence
Our team of scientists and engineers draws on decades of combined experience in bioprocessing, ensuring robust solutions for even the most complex production challenges. - Customization & Flexibility
Whether you need small batches for specialized testing or large runs for commercial distribution, our scalable processes and modular facilities can adjust to meet evolving demands. - Regulatory Peace of Mind
With ISO certifications, FDA registration, and a proven track record in compliance, Elise Biopharma provides confidence that your products are manufactured under globally recognized quality standards. - Dedicated Partnership
We view ourselves as an extension of your team, offering personalized project management and transparent communication. Our success is measured by your milestones, and we commit ourselves fully to helping you achieve them.
Collaborative Path to Market Success
At Elise Biopharma, contract manufacturing is more than just producing a product—it’s about forging a strategic partnership that accelerates your journey from concept to commercialization. Whether you’re an emerging biotech in need of pilot-scale support or an established diagnostics leader seeking a reliable OEM partner, our comprehensive services can be tailored to your precise requirements.
Ready to scale up or streamline your production?
Contact our Contract Manufacturing & OEM Services team today to discuss your project goals and discover how Elise Biopharma can help you bring high-quality, compliant products to market—efficiently and confidently.