12 services found
CELONIC Group Services
-
Fed-Batch & Perfusion Service
We have developed many continuous and fed-batch bioprocesses to manufacture complex proteins. Our manufacturing philosophy is based on single use technologies. For fed-batch and perfusion processes we have single use bioreactors of up to 1000 L in operation. Our Heidelberg facility routinely performs perfusion processes with up to 2000 L harvest volume per day over 30 days. For cell retention we are able to / can apply different systems like ...
-
Fast-Track Antibody Development Service
A powerful platform process, smart mitigation strategies, and state-of-the-art technologies – an elegant combination that can expedite your innovative therapeutics to the ...
-
Bio-Development Services - Process Development
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 products – support your challenges.
-
Cell Line Development Services
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 ...
-
USP Development Services
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 ...
-
DSP Development Services
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 ...
-
Analytical Method Development Services
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 ...
-
Bioassay Services
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 ...
-
Formulation Development Services
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, ...
-
Fill & Finish Services for Liquid-Formulated Drug Products
We offer comprehensive Fill & Finish services for liquid-formulated drug products – from aseptic filling to QC tests, labeling, packaging, storage, and release. Our solution-driven GMP-complaint processes come with unparalleled flexibility, fully-adaptable to the unique needs of our clients. Having completed over 300 GMP filling batches, our scientists are highly experienced in keeping product losses and vial rejections to an absolute minimum, ...
-
mRNA Custom Development and GMP Production
Leveraging over two decades of experience in biotherapeutics development and GMP manufacturing, Celonic now offers expertise and capabilities for GMP-compliant process development and the scalable manufacture of mRNA drug substance (DS) for therapeutics and vaccines. Synthetic mRNA manufactured using in vitro transcription (IVT) represents a new class of drugs with applications in infectious diseases, cancer, and regenerative medicine. In vitro-transcribed mRNA can be engineered to transiently express proteins-of-interest within cells. Over the years, multiple technologies have been developed to overcome the inherent challenges of this drug class (e.g. delivery, immunogenicity and translational efficiency of synthetic mRNAs). As more mRNA candidates enter the development pipeline, there is an increasing demand for custom, high-quality, scalable GMP mRNA production capabilities.
-
Tailored mRNA Process Development Services
Celonic utilizes advanced instrumentation, multi-scale bioreactors and leading-edge technologies for process development, production and purification of mRNA ...
-
Compliant GMP Manufacturing Services
Leveraging its more than two decades of experience in the GMP manufacture of complex biomolecules, Celonic provides tailored solutions to its ...
-
In-House Analytical Solutions for mRNA
Using state-of-the-art technology and instrumentation for mRNA characterization, Celonic provides custom analytical method development, specific to the client’s target molecule. The analytical capabilities ensure high quality, consistency and reduced timelines throughout development, GMP testing and release: Content and identity using fluorometric assays, qPCR, mass spectrometry and fragment analysis. Purity assessment and characterization of ...