Understanding the development journey of biopharmaceutical medicines is crucial for appreciating their impact on healthcare. mAbxience, a leader in the biopharmaceutical industry, has been at the helm of this journey, leveraging cutting-edge technology and expertise to make high-quality medicines accessible across the globe.

In this blog, we share insights from our dedicated team at Genhelix in León (Spain), about the intricate development process of these therapies.

Scalable growth and harvest: the upstream phase

In biopharmaceutical manufacturing, upstream processing involves the initial stages of production, focusing on the cultivation and growth of cells. Key activities include cell line development, media preparation, cell culture, and fermentation. These steps are designed to generate a sufficient quantity of the desired biological product, such as proteins or antibodies, with high yield.

“With single-use bioreactors ranging in capacity from 200L to 2000L and a second line of up to 4000L bioreactors, we are able to speed up the development of the product. We can also produce different products within the same day with no cross-contamination, adapting with flexibility and agility to our clients’ needs,” explains Belén Chico, Upstream Production Technician at Genhelix.


Refining to purity: the downstream process

At this stage, the product obtained from the harvest in the upstream processing is purified and refined through filtration and chromatography techniques. The goal is to achieve a highly purified, safe, and effective biopharmaceutical product ready for therapeutic use, ensuring it meets all regulatory and quality standards before packaging and distribution.

David Picó, Downstream Manufacturing Operator, unveils: “State-of-the-art filtration technology is applied, like AKTA systems and high-performance chromatography techniques like anion and cation exchange chromatography (EC) and other specialised chromatography techniques like pyroconversions.”

“Apart from purifying the proteins, we perform viral inactivation and a last stage of nanofiltering to eliminate any substances that shouldn’t be in the final product,” adds Elisa Santiago, Downstream Manufacturing Supervisor. “Once we have achieved an optimal degree of purity, we can prepare the protein for fill and finish to send to our colleagues in Madrid.”


And to the lab bench for analysis: quality control

Quality control (QC) in biopharmaceutical manufacturing is a comprehensive process involving rigorous testing and analysis to ensure that the final product is safe, effective, and of the highest quality. This stage is vital as it safeguards patient health and provides data that can be used to refine and improve the processes, optimising production and quality.

Coral Carretero is the Quality Control Coordinator at Genhelix, supervising the team of scientists who “perform assays at both the production stage and the final products ready to be delivered to the patients”, as she explains. “We use high-resolution liquid chromatography (HPLC and UHPLC), particularly Waters’ latest generation technology”.

Overall, the QC stage includes sampling and analytical testing for potency, purity, identity, and stability, as well as microbiological tests for sterility, endotoxins, and bioburden. Physical and chemical tests such as pH, osmolality, and viscosity assessments are conducted, alongside short-term and long-term stability studies. All results are meticulously documented to maintain regulatory compliance, ensuring consistently high standards.

mAbxience’s facilities have been endorsed with Good Manufacturing Practices (GMP) certifications by major regulatory agencies, including FDA, EMA, Japan PMDA, Australia TGA, Canada, Saudi Arabia, COFEPRIS (Mexico), Russia, Turkish MoH, ANVISA (Brazil), among others.


From bench to market: quality and innovation across the world

The journey of a biopharmaceutical medicine from development to market is a complex and meticulous process, involving upstream cultivation and growth of cells, downstream purification and refinement, and rigorous quality control to ensure the highest standards of safety and efficacy. mAbxience has been at the forefront of this journey, leveraging advanced technology and a dedicated team to produce life-saving medicines. Our three global state-of-the-art Biologic Drug Substance (BDS) facilities, such as Genhelix in León, and our commitment to quality and innovation have led to a solid portfolio and global market partnerships ensuring access to quality medicines across the world.

For more insights and updates on our latest innovations, follow mAbxience on LinkedIn. Stay informed about our continued efforts to advance healthcare and make high-quality biopharmaceuticals accessible to patients worldwide.