Biopharmaceutical Global Partners

Our head of Biopharmaceutical Testing Pablo Cobo, Chemistry graduate and biologics pioneer, remembers his early days at Ipsen when peptide product development was quite different:

“Back in 1994 biopharma companies did most of their development work in-house but because of the high costs of specialized personnel and instrumentation they began to outsource testing activities to third-party research organizations” states Mr. Cobo. “Nowadays companies lacking the necessary infrastructure can develop specific biologics and biosimilars in a cost-effective way thanks to specialized CROs and CDMOs.” 

Current challenges in the testing of biopharmaceuticals 

KYMOS’ biopharmaceutical department focuses on quality control of innovative biologics and biosimilars, the two main biopharma segments, but the demand for biosimilar comparability studies has increased significantly in recent years. Pablo Cobo has an idea about why that might be:

“Similarly to what happened with generics in the 80s, many blockbuster biopharmaceuticals are seeing their patents expire and are now in high demand as biosimilars. We are currently working with dozens of biosimilars and transferring methods from clients across the globe: Monoclonal antibodies (mAbs) from Asia; recombinant hormones from Latin America; growth factors from Europe… Working with biosimilars and their reference biologics is challenging because they are as diverse as they are molecularly complex and being equipped to perform all the different assays required for their characterization is not always the most efficient option. As a result, companies interested in entering the biosimilars market tend to outsource testing services more often than generic firms did before.” 

This positive trend is so strong that despite the coronavirus outbreak, Pablo’s team has experienced a 2.5-fold rise in service demand and a 44% increase in the average value of approved quotes compared to the same period in 2019.
“We foresee in the mid-term biosimilars will amount to the largest percentage of our department’s activity,” concludes Mr. Cobo.

What can KYMOS’ biopharmaceutical testing team offer than other CROs do not?

Pablo Cobo is proud of his team of in-house trained experts and well-provided facilities, but there is yet another important reason why our clients choose KYMOS as their reference laboratory:

“Many of our customers come from countries like China, South Korea, Singapore, Lebanon, India or Argentina, where other CRO alternatives and business-friendly regulations can be found,” begins Mr. Cobo. “However, all medicines manufactured outside of the EU/EEA, including biopharmaceuticals, must be tested by a certified EU laboratory before market release. The fact that we are also certified importers and manufacturers, able to provide importation, batch testing and QP batch release services, makes it more convenient for those firms to transfer their manufacturing methods to KYMOS: We can assist them throughout the entire process.” 

One of such global clients is CELLTRION, a leading South Korean company specialized in biosimilar mAbs and innovative biologics. Yong Suk Yang, Global QC Operation Team Manager at CELLTRION, shares his experience working with KYMOS:

“We are currently developing multiple new biosimilar projects beyond our flagship product Remsima (an infliximab biosimilar sold as Inflectra in the US) and consider KYMOS one of the best CROs in Europe for drug release and testing.” 

Pablo Cobo adds to Mr Yang’s words with his personal take on previous projects:

“CELLTRION is a company with robust analytical methods and a deep understanding of their portfolio. Working for them has been a true privilege, as it has given us the opportunity to implement high-performance mAb characterization techniques such as capillary electrophoresis or image isoelectric focusing Protein Simple (iCE3).” Mr. Cobo continues: “I consider our clients’ projects as a partnership that works both ways: We assist them in all their QC needs and acquire valuable know-how in the process. After many years testing innovative biologics and biosimilars our experience speaks for itself.”

Future expectations
In 2012 KYMOS’ Biopharmaceutical Testing department consisted of only two members. Today, after one relocation and two laboratory extensions Pablo’s team has grown nearly tenfold and enjoys an optimistic growth forecast fueled by current outsourcing trends. Their consistent and reliable work has earned positive feedback from clients worldwide and has placed KYMOS as one of the TOP 10 global biosimilar service providers. So with such an enviable position, what more could Pablo Cobo ask for? His response is immediate:

“A new lab! We just expanded our facilities last year but are already running short of space!”

Here you can view more information about KYMOS’ Biosimilar Testing; Characterization of Biologics and Biosimilars and Bioanalysis of Biologics and Biosimilars or contact us on commercial@kymos.com.

CELLTRION is a leading force in the Korean pharmaceutical industry. They launched the world’s first “antibody biosimilar” from a country with a relatively underdeveloped pharmaceutical sector and plan on growing as a global biopharma company with unique approaches to small molecule pharmaceuticals and new businesses such as the Ubiquitous-healthcare platform business. For more information about CELLTRION contact them on contact@celltrion.com.