Bioprocess Development
We develop stable and robust cell lines and establish cell banks (MCB and WCB). We also develop and optimize processes for the manufacturing and purification of recombinant proteins. Our world-class analytical capabilities and best-in-class formulation development in collaboration with Leukocare complete our portfolio.
Cell Line Development
We offer you comprehensive expertise in the development of robust, high-performance cell lines. Do you have a sequence or a vector? We develop and establish a stable cell line and cell banks (MCB and WCB) for your molecule.
Our Expertise
- Application of mammalian cell lines for the expression of recombinant proteins
- Development of high-yield production cell lines
- Animal component free media
- Our in-house platform for difficult-to-express proteins (directed integration)
- CellcaCHOTM platform (random integration)
Your Benefits
- Predictable, robust, and scalable CHO cell lines
- Compliance to cGMP guidelines
- For all types of recombinant proteins
- Expression platform seamlessly integrated into USP platform process
Process Development
We are specialists in development, optimization and validation of cell culture and the purification of recombinant proteins. We work with economical best-fit technology platforms. We develop processes customized to your active pharmaceutical ingredients and ensure an efficient process transfer.
Our Expertise
- Development of customized upstream processes (USP) and downstream processes (DSP), process transfer and process optimization for optimum yields
- Platform as well as customized processes
- Process characterization and validation
- Cell culture in fed-batch, continuous & perfusion mode
- Enrichment of your protein and removal of all process-related impurities
Your Benefits
- Established experience in process development
- Reliable and fast process implementation
- Transfer and optimization of your processes
- Customized concepts for a broad range of biopharmaceuticals
- Our unrivaled know-how with complex and difficult-to-express proteins
Formulation Development
Strategic Alliance with Leukocare AG
Rentschler Biopharma’s strategic alliance with Leukocare offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process.
Expertise
Operating at the interface of drug substance and drug product development, Leukocare combines profound knowhow in biopharmaceutical formulation development combined with innovative biostatistics and artificial intelligence (AI) expertise. By applying a maximum design space and specifically combining excipients in a DoE based approach, Leukocare is able to add value to the product. This leads to stabilizing formulations tailored to the product’s needs. Leukocare holds development laboratories and offices in Milford, MA, USA, located at Rentschler Biopharma´s Milford premises.
Your Benefits
- Best-in-class formulation provides significant competitive advantages
- Advanced formulation maximizes product potential
- Provides optimal direct benefit to patient, physicians, payers
- Maintains efficacy and safety of products during storage
- Improved cost efficiency in product planning and development
- Optimizes planning of clinical trial programs (especially timing the start)
- Early adoption of an advanced formulation in clinical trials can avoid the need to repeat them and simplify compliance with regulatory agencies
- Improved market implementation logistics
Analytical Development
With almost 50 years of experience in the development of a wide range of analytical methods, we ensure the quality and purity of your product in accordance with all cGMP guidelines.
Our Expertise
- Development of various testing services including identity, purity and potency testing
- Broad spectrum of analytical methods
- cGMP compliant method validation and transfer
Your Benefits
- Fast and flexible development of robust analytical methods
- Established experience and reliability
- Expertise with diverse recombinant proteins
