Drug Substance
Drug Substance production capacities
Eurofins CDMO (Contract Development & Manufacturing Organization) network of companies delivers solutions to its customers for the development and biomanufacturing of a broad range of biological molecules and product types such as antibodies, proteins, enzymes, vaccines and different types of bacteria.
All innovative products start with proof-of-concept studies, and we understand the need for quality even though initially only small quantities of material for activity studies are needed. We can perform small research scale productions, not only with a cost-efficient proposal, but also with an eye on scalability of processes, and regulatory challenges that might be met later on. The segregation in our facilities enables us to produce small (non –GMP) batches at competitive pricing, without compromising on quality.
At the core of our business is our comprehensive expertise in developing bioprocesses for a broad range of products (including proteins). Once a molecule has passed the efficacy hurdles, and in case there is a need of supply for safety studies, we will work to develop a production process optimized for rapid delivery of high quality material for preclinical and toxicology studies, and scalable – if not even fully representative – for production of clinical supply for Phase I and beyond.
Building on the CMC expertise and the comprehensive experience of our scientific experts, we will deliver a GMP manufacturing program representing an optimal balance of speed, budget, scalability to Phase III and commercial production volumes, and – last but not least – regulatory requirements.
For certain applications, our clients need very large amounts of high-quality material, manufactured in a non-GMP environment. We cater to such needs, and regularly deliver batches of grams of highly pure protein, produced under an internal quality system.
Technologies available
Our team optimizes expression of prokaryotic and eukaryotic organisms and develops the complete purification process. We have decades of experience with a broad range of microbial expression systems, from the well-known work horse E.coli (soluble and insoluble, peri- and cytoplasmic) to high-efficiency yeast systems, such as Pichia, Hansenula, or alternatives such as Streptomyces.
Cell line development
Microbial strain development services include gene and codon optimization of the expression plasmids, clone selection based on product attributes and cell culture performance, and yield optimization in small scale Experimental Design studies.
Establishing recombinant protein expression in insect cell expression systems such as S2 and Sf9 cells is another alternative we can offer – we have ample experience and expertise working with a variety of systems in this area.
Last but not least, our crew has extensive experience with a number of mammalian expression platforms, including CHO, HEK293, NS0, and Per.C6 cells, both in transient and stable expression mode.
Upstream Processing
Our Upstream processing capabilities include various options for high density fermentation, in batch, fed-batch or perfusion mode.
Culture conditions can be developed and optimized in several 1,5 L vessels that allow parallel runs with different parameter sets and DOE-type experiments to rapidly find the optimal conditions for fermentation and expression yield under production conditions. Once parameters have been fixed, the process is scaled up.
You can choose from different technology platforms : from spinner or shake flasks, wave bags, roller bottles or cell factories to stainless steel fermenters or single use bioreactors. We can up-scale from very small batches to 200 L.
Downstream Processing
Our Downstream Processing team has decades of experience and a vast amount of knowledge in the development of purification protocols and downstream processes, including protein formulation. We have established cost-efficient, rapid and ingenious small scale standard procedures, in order to screen for optimal matrices, and develop methods and protocols for purification. We have a broad range of chromatography and filtration technologies at our disposal, and are continuously expanding and updating our capabilities in this field.
Analytical QC
We have a comprehensive portfolio of Analytical Competences at our disposal, covering Biochemical and Biophysical Methods, and Bioassays. These technologies allow us to monitor the production process, characterize ' critical attributes, and allow for a tailored match regarding product release. Our services include method development, qualification and validation.
Choose Eurofins CDMO network of companies to help you with production of your biological Drug Substance:
- Flexible production of biological drug substances, tailored to your need.
- A wide range of expertise in different prokaryotic and eukaryotic expression systems.
- Cell line development, upstream development, downstream purification processes and product analysis are all aligned in-house.
- Together with you, we will plan the most time-saving and economically interesting process for your requirements.
