CELONIC Group 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 costs.

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).

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.

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.

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