We service clients that develop protein products (independent of product area).
Biopharmaceuticals, Diagnostics, Biotech, Med Tech and Laboratory Chemistry
- Rational planning in Development of purification of protein products.
- Focus is on early characterization of process performance and time-lines in development of production.
- Cost efficient planning (development and production economy).
- Process development – from laboratory to pilot scale verification, both management consultancy and laboratory work (practical and R&D support).
Investing in planning of the early work is especially important within the Biopharmaceuticals sector. The time-lines are crucial and the financial risks involved in prognostic statements in Communication with Investors are huge.
The importance for early decisions on CMC strategies and timelines, is often overlooked by companies that focus on the pre-clinical development. Ideally our Bioharma clients contacts us at the pre-clinical stage before entering the TOX stage. At the latest shortly after TOX, as a follow up of quality issues in the future scaling-up of production based on the current development for production of TOX materials. We like to help out in developing a production perspective, including the needed documentation already at this early stage.
With a focus on a cash flow sensitive value creation, we can make a difference for our customers in securing scalable process development.
In this we include process scaling and removal of technologies or methods that are unsuited for future GMP production.
Ceffort ControlSep is a Contract Research and Development Organization partner (CRDO). Our CMO services are limited to transfer of a designed production process (including operational procedures) to the chosen production site or manufacturing partner.
We adapt the development strategy of your production process to current international regulatory and other guidelines for the intended use.