Lipids CDMO Services
Custom Synthetic Lipids for Pharmaceutical Applications
As a key partner in your journey to commercialization, we leverage over 25 years of experience within our globally integrated CDMO and testing capabilities. We are dedicated to supporting you through every development phase. Our customized services range from the development, optimization, and scale-up of lipid processes to accelerating your drug development program, whether you're working with grams or multi-kilograms, all at our Schaffhausen Lipids Center of Excellence.
Our Track Record
25+
Years experience of custom process development for Lipid synthesis and manufacturing
2023
Launch of new commercial kilo-lab tailored to applications in small-kilogram range
50+
lipid projects scaled-up
Benefits of our custom lipid CDMO services
Our state-of-the-art manufacturing assets are engineered to offer flexible and customized processing capabilities tailored to meet your specific needs. With a long-standing experience in lipids development and GMP production, our fully integrated analytical development team is ready to support you get access to high-quality material to ease the translation of your drug product from pre-clinical to clinical manufacturing.
Pre-Clinical
- Route scouting
- Process and analytical development
- Synthesis optimization
- Preparation of Tech-Batches
- PAD capacity: <1 kg
Clinical
- Technology transfer
- Process industrialization and scale-up
- GMP manufacturing for clinical phases
- Down filling
- Quality control
- CMC support
- Project management
- Preparation of validation campaign (Ph III)
- GMP pilot plant: <1-3 kg
Commercial
- Process performance qualification
- Commercial GMP manufacturing
- Down filling
- Quality control
- Supply chain
- Commercial project lifecycle management
- Commercial Production lines: 1-80 kg+
Let our team of experts assist you in your journey from pre-clinical to commercial. To request information about our timelines and availability, click here.
Partner with us to bring transformative therapies to patients:
- Proven track record: GMP compliant Lipids production in small to large scale quantities for all clinical and commercial phases
- State-of-the-art manufacturing assets: with more than 25 years of experience, you can leverage our internal process development expertise to design scalable synthesis routes
- Fully compliant inspected GMP manufacturing*: de-risk your program by having cGMPs and site standards that follow ICH Q7 concepts, as well as an excellent track record of customer and Health Authority inspections
- Dedicated project management: ensuring that projects are delivered on time, within budget, and to the highest possible standards
- Phase appropriate regulatory support: from our dedicated team of experts to ensure compliance across your clinical to commercial journey
In addition to our custom Lipids CDMO services, we also offer a standard off-the-shelf portfolio with optimized stability, solubility, and handling characteristics.
Related Resource
- Flyer: Lipids for Pharmaceutical Applications
Your global partner for the manufacturing of synthetic lipids.
Related Webinars
Our experts present key considerations to select the right lipid excipients and the process development steps necessary to bring a LNP formulation to GMP manufacturing and clinical trials.
This webinar gives insight into customized LNP formulation development for novel therapeutic modalities. The manufacturing, optimization, analytical characterization, in vivo testing, and scale-up strategy for LNP is discussed.
Request Information
For additional information or to be contacted by a sales representative, please complete and submit the form below.
Fields indicated by an * are required.
Para seguir leyendo, inicie sesión o cree una cuenta.
¿No tiene una cuenta?