Innovation and Compliance Services for Recombinant Albumin
Four decades of experience pioneering albumin enabled solutions makes us the perfect partner to drive your project toward commercialization. We offer a range of bespoke innovation and compliance services.
Innovation Services
Albumin Enabled Solutions We Deliver
Our experts can help increase your likelihood of technical and commercial success, working to optimize performance, quality, or consistency to benefit your processes.
Albumin-enabled solutions can be delivered through several services, including:
For a More Seamless Transition Into the Clinic
Complex biopharmaceuticals and advanced therapies can present challenges during preclinical development. When implementing an albumin-based solution, Sartorius can help avoid unnecessary complications in your preclinical testing by creating species-specific recombinant albumins to suit your preclinical models.
Using our proprietary recombinant expression and bioprocessing platform, we can create a surrogate albumin to match your preclinical model, which is consistent with the same high quality, purity, and human- and animal-free nature that you can expect from our Recombumin® products. Our species-specific albumins are manufactured in our state-of-the-art Technology Centre to ensure suitability for your preclinical development programs. In using the same albumin production host and representative manufacturing processes, we can help you transition more consistently and seamlessly into the next phase of clinical development.
Unlock the Full Therapeutic Potential of Your Biopharmaceuticals
Albumin is a well-documented, safe, multifunctional formulation excipient for biopharmaceuticals and advanced therapies enabling it to address key formulation and stability challenges not possible with classical formulation strategies.
What works for you, works for us. Sartorius scientists can provide customized support to suit your needs; whether it be developing bespoke formulations of recombinant albumin for use within your application or improving your final product formulation with our Recombumin® products. From solving solubility issues, improving stability, enhancing cell viability and cryopreservation through to improving transduction efficiency of viral vector based therapies and vaccines, the possibilities with an albumin-based solution are endless.
Drive Efficiency in Your Process to Improve Overall Product Performance
Not only is albumin’s use as an excipient well-documented in formulation development, it can also offer many benefits during processing to improve both yields and quality. Sartorius is continually researching ways in which our Recombumin® products may improve performance, quality and consistency, meaning we can use our learnings to optimize your process.
Our albumins may be particularly beneficial in improving cell viability and efficacy throughout the cell therapy production process such as harvesting, expansion, cryopreservation, and thawing of your product. Using our albumins and expertise, Sartorius can develop bespoke media tailored for your cells at each process stage in order to maximize success throughout manufacture into storage and beyond.
Similarly, we have seen benefits of our albumins when used in viral vector manufacture from its production in cell culture, through the downstream processing and into formulation, Recombumin® can be used to improve the yield and quality of your viral vector. Using our know-how, Sartorius can refine how and when Recombumin® is used effectively in the production of viral vectors and vaccines to enhance transduction efficiency, viral integrity, and reduced viral aggregation.
One Size Doesn’t Fit All – Let’s Find a Solution That Fits Your Needs
With our longstanding albumin heritage, we can utilize our knowledge and expertise to produce a recombinant albumin as unique as your product and application demand.
From bespoke formulations to alternative presentations, our dedicated recombinant human albumin GMP manufacturing facilities can meet your needs. Similarly, our state-of-the-art technology centre can accommodate development and production of bespoke recombinant albumin suitable for use in discovery through to preclinical studies.
Compliance Service
Our experienced quality and regulatory teams can be on hand with a range of bespoke compliance services, designed to empower success in your development.
Compliance Services offered include:
Navigating the complex and ever-evolving regulatory landscape can be difficult. As 'time to market' continues to be a challenge across the life science industry, in-depth knowledge and strategic oversight into the regulatory realm is becoming an increasingly important consideration.
Our albumins are not only the highest quality and consistent on the market but are also supported by the most comprehensive regulatory package available. With 40 years' of experience, our team of regulatory experts has a proven track record of successful interactions with many world-leading regulators to help you navigate regulatory hurdles no matter what stage of development or lifecycle management. Whether it be the provision of our extensive Drug Master File documents, or the creation of a bespoke regulatory package and response to agency questions, our in-house regulatory experts carefully balance regulatory requirements, scientific standards, and ethics to get you onto the market quickly and safely.
Sartorius manufactures the highest-quality recombinant human albumins available in our commercial-scale manufacturing facility, operated at ICH Q7 GMP standards. Certified by the MHRA, as well as having been inspected by other world-leading authorities, it's safe to say we know a thing or two about upholding high quality and regulatory standards. Through our proven systems and processes, our QC, QA, and validation experts are available to lessen your quality and analytical challenges by providing assistance with:
- GMP incoming-lot testing
- Bespoke stability studies
- Custom Certificates of Analysis
- Method validation
- Tailored audits
Our four decades of album experience has led to us learning a lot about the characterization challenges that working with and implementing protein-based solutions can present.
Are you spending valuable time developing assays to account for albumin interaction? If so, we can help! Using our extensive experience in modulating albumin to optimize performance, our technical team can work side by side with you to develop robust and reliable methods tailored to suit your application.
