CELONIC Group services

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 centrifugation and Alternating Tangential Flow.

A powerful platform process, smart mitigation strategies, and state-of-the-art technologies – an elegant combination that can expedite your innovative therapeutics to the patients.

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.

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.

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.

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.

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.

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.

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, which is especially critical for clients with low bulk volumes (1– 10 L).

Celonic utilizes advanced instrumentation, multi-scale bioreactors and leading-edge technologies for process development, production and purification of mRNA candidates.