Grifols Partnership, is a contract development and manufacturer (CDMO) focused on added-value injectable products for small molecules, headquartered in Barcelona, Spain.
In this episode of the PharmaSource podcast, Marga Viñes Senior Business Development Manager for Grifols contract manufacturing, explains the drug development and manufacturing services that they offer to customers.
“Grifols is mainly known in the blood-derivatives field.” says Marga. Additionally the company’s “contract manufacturing experience in injectable drugs led to us offering CDMO services focusing on Orphan drugs. We are very specialised in small-volume parenteral manufacturing.”
The trend from Blockbuster to Nichebuster
Grifols Partnership typically focus their contract manufacturing expertise on developing smaller-scale programmes targeting rare diseases in the United States and Europe.
“The industry is becoming more focused on orphan drugs rather than the development of blockbuster drugs with large populations” says Marga.
“The shift is being driven in part by new legislation. This paradigm creates opportunities for smaller pharma and biotech to bring new medicines to the market.”
Quality by Design
A differentiator for Grifols is their “Quality by design” philosophy, which goes beyond operating FDA, EMA and GMP-approved facilities.
“We have implemented a quality‐by‐design approach to process development and enhanced our process control capabilities. We also have an established change management control system and have introduced automation technologies to further minimise the potential for error and contamination in our parenteral products.” says Marga,
“At Grifols, safety is more than just a regulatory requirement. It is methodology that steers all operational decisions as we all strive to improve the wellbeing of patients and their quality of life.”
An example of this is how Grifols manufactures their own flexible bags on-site to obtain a perfect match between the drug and its container. This vertical integration model enables the CDMO to control the entire process and ensure the highest standards of quality at all stages of manufacturing.
Meet the Grifols Partnership team at CDMO Live 2024. Find out more here
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