Whether you need help with a specific phase of your program, or you require full-scale support from development to commercialization, we provide complete CDMO (contract development and manufacturing organization) services for injectable pharmaceuticals and medical devices.
As a global manufacturer of sodium hyaluronate, decades of success with difficult and highly viscous products (in excess of 100,000 cP) prove that we’re capable of undertaking any new challenge, big or small.
Sustaining Customer Confidence
High-quality, U.S.-made sodium hyaluronate (5KDa – 1.8MDa) produced using a proprietary microbial fermentation and purification process.
- Pharmaceutical grade
- Research grade
- Hydrogels
- Custom modifications
Moving from the Bench to the Clinic
Expert process, analytical, and supply chain assistance from concept to commercialization with a focus on efficiencies throughout.
- Formulation
- Process development
- Analytical method development and monitoring services
Optimizing Pharmaceutical Production
Injectable products for clinical and commercial use manufactured by skilled staff at three cGMP facilities.
- Sterile filtration and aseptic filling with expertise on complex products
- Multiple vial, syringe and cartridge sizes and configurations
- In-house labeling and packaging
Care and quality to the core,
no matter whose name is on the product.
As a manufacturer of our own products, our quality and safety culture has advanced the Lifecore brand for decades. When CDMO customers entrust us with their brand and reputation, we demonstrate the same commitment to quality by providing exemplary products, services, and communication.
Quality Management System (QMS)
Our QMS ensures we comply with applicable standards, regulations, and statutory requirements.
In-house experts ensure sterilization processes, controlled environments, equipment, and cleaning processes are routinely monitored and revalidated as needed.
Lifecore’s QMS supports:
- Active Pharmaceutical Ingredients (API’s)
- Medical Devices
- Pharmaceutical drug products
- Combination products
QMS Compliance and Certifications
Compliance
- 21 CFR 820 (FDA Quality System Regulation)
- 21 CFR 210, 211 (FDA Good Manufacturing Practice)
- EudraLex Volume 4 (EU Good Manufacturing Practice)
- EN ISO 13485, Medical Devices – Quality Management systems – Requirements for regulatory purposes
- ICH Q7, GMP Guide for Active Pharmaceutical Ingredients
Certifications and Registrations
- Registered FDA Device and Drug Establishment
- Certified ISO 13485 Quality System
- Certificate of Suitability to the Sodium Hyaluronate Monograph of the European Pharmacopoeia
- European GMP Certification
- Japan Foreign Manufacturer Accreditation
- MNSHARP Certification (MN Dept. of Labor and Industry)
Customer Support and Audits
- Pharmaceutical development, quality assurance and regulatory experts offer timely guidance supported by robust data which enables regulatory submissions and ensures the safety and compliance of clinical materials and commercial products.
- All customer and agency audits are managed by QA and regulatory departments along with dedicated project support teams. Keeping services in-house provides a central point of contact for a smoother compliance process.
Decades of experience, infrastructure, and expertise enable unique capabilities to serve all types of customers.
Get to Know More about Lifecore
From our people and purpose to our facilities and focus, learn why customers partner with us for end-to-end solutions.
Discover Our Analytical Services
Experienced staff at our on-site labs maintain greater control of samples and products, minimizing risk and shortening timelines.