We provide tailored solutions and enable your high-potential molecules to become a market success. Our integrated services – from cell line development to commercial manufacturing of drug substance– support your challenges.
- Market Supply
- Clinical Supply
- Formulation Development
- Analytical Method Development
- Cell Line Development
- Fill & Finish
- Pre-Clinical Supply
- Process Development
- Cell Bank Manufacturingt
- Antibody Engineering
Cell Line Development
Our cell line development services provide a GMP-compliant and cost-efficient basis for your project. Our proprietary technologies, CHOvolution® and human-based GEX® cell lines, offer solutions which can be adapted according to clients’ specific needs. CHOvolution® and GEX® enable high titers and fast-track development. Furthermore, GEX® enables fully human and/or specific glycosylation patterns and the efficient expression of difficult-to-express proteins.
Have a look at our Cell Line technologies:
- GMP-compliant cell lines for both R&D and all the way to commercial market
- CHO and human cell line based platform technologies
- Glycosylation optimization (fucose, mannose and sialic acid content)
- Manufacturability and/or developability testing
- Mock cell line generation
- Accelerated cell line development in 4 months
- Cell line stability studies
- cGMP cell banking and storage
- Documentation for IND filing
Our highly experienced USP development team provides you with robust and cost-efficient process development. From media development to process optimization, we have the know-how to adapt and optimize processes in order to increase expression titer and strengthen cell viability.
- Media development/optimization
- Feeding development/optimization
- Optimization of process parameters
- Shear stress testing
- 1 L, 10 L, 100 L and 200 L volume bioreactor systems for non-GMP development and affordable pilot runs.
Efficiency is the key for a good downstream process to obtain consistently a pure and high quality product while recovering as much target protein as possible. Celonic has set up a downstream platform process for antibodies, often recovering more than 75% of the target mAB. This saves considerable development time and costs.
In addition, our experience in process development for non-antibody products enables us to maximize the product recovery during platform adaptation.
- Adaption of state-of-the-art purification processes for mABs
- Process development for non-antibody products
- Process intermediate stability studies
- Virus clearance studies
- Extensive experience in purifying products from in-house CHOvolution® and the human GEX® cell line
Analytical Method Development
Our analytical method development department is equipped with state-of-the-art instruments, such as capillary electrophoresis and mass spectroscopy, providing a broad spectrum of relevant standard antibody methods. Celonic also has substantial experience in developing analytical methods for non-mAb molecules ab initio.
We perform method development, including GMP-compliant method validation and stability studies. We also collaborate with well-established partners with extensive experience in specialized characterization methods so that we can offer a full service within an all-round care package. We have expert knowledge of a range of molecules, such as monoclonal antibodies, antibody fragments, fusion proteins, blood factors and enzymes. Celonic is also experienced in developing analytical strategies for biosimilars, including reference product sourcing.
We have outstanding technical expertise and put a strong focus on our collaboration partners and clients. Flexibility, fast individual response and customer support are a natural part of our daily business.
Bioactivity of final products is a key feature in the specification of biopharmaceutical drug substances and clinical samples. Therefore, choosing the right partner for bioactivity and technically challenging cell-based assays is crucial. Consistent assay performance requires a controlled setting, highly skilled analysts with a deep understanding of cell physiology and well-developed and characterized methods. Successful development of such assays requires expertise – and that only comes with experience.
Celonic is your dedicated expert partner for all aspects of bioassay development, validation, method transfer and long-term assay maintenance. We have broad experience in GCLP assay development at Celonic and a proven track record in establishing qualified and validated methods for product quality control. For decades, we have successfully applied our know-how, proficiency and expertise in immunology and routine assays. With our broad experience, we stand for quality completion of your testing program.
We specialize in:
- Specific binding assays
- FcgRIIIa binding assays
- Antibody-dependent cell-mediated cytotoxicity (ADCC)
- Cell proliferation assays, cell based potency assays for rhGH, G-CSF and GM-CSF
- Custom-made NK cell cytotoxicity assays
- Custom-made lymphocyte proliferation assays
- Evaluation of customer-provided samples
ProJect Pharmaceutics* builds quality into formulation and processes and applies high-throughput predictive stability technologies (Predictive Formulation Analytics, PFA) to ensure manufacturing consistency. Using such a regulatory-compliant Quality by Design (QbD) step at an early stage will result in an accelerated and risk-mediated downstream process (DSP) development. It will also generate a more stable final drug substance formulation that, ideally, results in a consistent formulation for drug substances and products.
- Quick identification of protein’s likes/dislikes (comfort zone) based on basic formulation profiling
- Optimized yield based on rationale design of stabilization concepts per DSP step within identified comfort zones
- Minimized aggregation tendency, even at high concentrations, based on rationale UF/DF development
- Accelerated drug product formulation based on thorough DSP groundwork
*A sister company of Celonic