Liposome cGMP Manufacturing
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CD Formulation has amassed extensive expertise through years of assisting numerous pharmaceutical companies, including the world's leading ones, in launching innovative liposome formulations. We are spearheading innovation in nanoparticles while maintaining a steadfast commitment to quality and regulatory compliance to enhance excellence. With our knowledge, flexibility, and global resources, we are well-equipped to take on any challenging project and reliably meet all your supply needs in a safe manner.
Our cGMP Manufacturing Capabilities
Our CD Formulation services facilitate the clinical production of diverse liposome formulations, including oral liquid, injectable, and oral solid formulations. Our cGMP capabilities encompass buffer preparation, filtration, phospholipid solution preparation and filtration, lipid hydration, extrusion, washing, dilution, sterile filtration, and filling processes tailored for each stage to expedite your drug's progression to clinical trials.
Comprehensive Manufacturing Support
- Support all manufacturing stages, including pre-clinical and clinical PhI - III
- Clinical sterile pharmaceutical manufacturing and filling capabilities
- Platforms for the development and manufacturing of nanomedicine products
- Dynamic manufacturing, adaptive environment
- Formal controls, robust and mature quality systems
- Process verification
- Quality control process inspection and release
- Record of timely delivery
- Extensive management and operational experience
- Enhancing manufacturing flexibility to expedite clinical development
- Commitment to ensuring quality and maintaining data integrity
- Sustaining improvement of quality
- Review the preparation and conduct an audit
- Regulatory guidance
State-of-the-Art Facilities
CD Formulation's facilities meet the demands of liposome manufacturing for each phase of development. Our cGMP facility has been designed by liposome and regulatory experts to streamline late-phase clinical liposome drug manufacturing. Key facility features include:
- cGMP facility
- ISO 7 and ISO 8 cleanrooms: multiple clean rooms Suites Compliant with cGMP Standards.
- Designated cleaning areas, including D-level, C-level, B-level, and sterile filling areas for B+A environment.
- Increased liposome capacity
- On-site Quality Control and release testing
- Buffer prep and hold area
- Aseptic bulk aliquoting suite
- Single-use consumables and process flows designed for cGMP manufacturing
Our Specialized Liposome cGMP Manufacturing Services
- Expertise in formulating and designing liposome formulations.
- Comprehensive lipid inventory with customizable formulations starting at 10 mL.
- Tailored lipid synthesis for your specific liposome formulations.
- Development of liposome drug delivery systems for active pharmaceutical ingredients (APIs), nucleic acids, proteins, small molecules, antibodies, and more.
- Scalable production techniques from 1 mL to 50 L using advanced methods, including high-pressure homogenization and microfluidic technology.
- Clinical trial material production in our cGMP production suite.
- Recommendations for sterile filtration facilities for parenteral products.
- Cross-functional coordination for analytical method development, validation, and stability studies.
- Support for technology transfer to your preferred facility.
- Enhanced production capacity tailored to your product requirements.
- Long-term integrity and quality assurance for your product.
- Seamless transition into commercial pharmaceutical manufacturing.
Why Choose CD Formulation?
- Cutting-edge Liposome Research, Optimization, and Production Techniques. We are committed to establishing a comprehensive CDMO platform for biopharmaceutical R&D and production. We are dedicated to delivering the most professional, efficient, and reliable services to expedite the commercialization of biopharmaceutical products. Our end-to-end biopharmaceutical solutions encompass contract R&D, manufacturing, testing, consulting, and other services, which we provide to clients globally.
- State-of-the-art cGMP Facilities. The cGMP facilities are designed and constructed in accordance with the GMP requirements of major regulatory agencies such as the US FDA, EMA, and PMDA. Furthermore, a comprehensive cGMP quality management system has been established to encompass all aspects including material systems, facility and equipment systems, laboratory control systems, production systems, packaging, and labeling systems. The manufacturing center is equipped with four formulation production lines; additionally, the filling line offers services for vials, pre-filled syringes, cartridges, sterile gel, and BFS in various formulations.
- Professional technical team. The core team consists of professionals from renowned biopharmaceutical enterprises, both domestic and international, specializing in vaccines, monoclonal antibodies, recombinant proteins, and chemical pharmaceutical formulations. They possess extensive expertise in the development, clinical registration, quality management, industrialization operations, and commercial production of biological drugs. The team has substantial experience in GMP certification and has obtained GMP certifications from a total of 13 countries and regions worldwide, including the US FDA, the EU EMA, and China NMPA.
As a leader in nanoparticle technology, CD Formulation is dedicated to providing professional liposome cGMP manufacturing services. Contact us for assistance in advancing your biopharmaceutical projects.
How It Works
STEP 2
We'll email you to provide your quote and confirm order details if applicable.
STEP 3
Execute the project with real-time communication, and deliver the final report promptly.
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