July 06, 2018

Biologics CDMO: 3 qualities often overlooked

By Cytiva

Bringing in external service support might feel risky when you want to maintain control over your process outcome and protect your intellectual property. A CDMO can offer 5 major benefits to your biomanufacturing organization. Here are 3 that are sometimes overlooked.

The experience and expertise of a well-established biologics CDMO can offer many benefits, especially if your business strategy is to ultimately control your own biomanufacturing destiny. Partnering with a CDMO can offer the training necessary to prepare you for that independence. This requires openness and collaboration with teams working openly side by side. If this happens, a CDMO’s team is not just developing the bioprocess with you but also sharing the reasons why it is being done a specific way.

Five Key Qualities of a CDMO

1. Transparency: Does the biologics CDMO foster an open partnership?

An open partnership depends on how the CDMO manages its customer on-site. It is up to you to vet any potential biologics CDMOs and find out how open they are willing to be over the course of the relationship. Ask questions, such as does the CDMO allow both teams to work openly in a pilot plant, or is your team allowed only in specific areas of the building during bioprocessing steps? Also, find out what the CDMO intends to provide at the end of the project. Does it provide documentation, such as analytical testing requirements and SOPs, and will it speak openly with you to support it on an ongoing basis, even after the service work is rendered?

For more detailed tips on building a transparent partnership with your CDMO, take a look at this article – The transparent CDMO: Maintaining autonomy in your biomanufacturing partnership.

2. Regulatory experience: Is the CDMO prepared for the challenges of global manufacturing?

When it comes to regulatory expertise, a CDMO should have the knowledge necessary to successfully deal with local authorities, particularly in emerging markets. It may even lean on established relationships with regulatory agencies. For example, when developing a process globally, work has to be done very early in the developmental setting to meet the needs of the market in which a company wants to enter. Having an understanding of what level of acceptance there is from the local regulatory agency is imperative. There are different challenges in various regions of the world that expose some of the IP associated with the molecule or the process itself. 

3. Intellectual property: How will the biologics CDMO protect your critical IP?

Additionally, a CDMO should be able to help build a strategy around protecting and preserving that critical intellectual property. It may use a well-established entity to do so. This includes establishing terms and conditions of an agreement all the way through the engineering modifications required to protect any electronic data generated during the process or even security in the laboratory to protect the cell line, such as cameras, physical locks on the bioreactors, and restricted access to cell line storage/cultivation. Another strategy would be to use a black-box approach, where the CDMO does not know what the molecule is, or it may not perform the testing itself. It provides only the development work and then sends the samples back to the customer for any testing. Having a plan to protect IT is especially critical in emerging markets, where there is the potential for differences in legal requirements to leave vital information dangerously vulnerable.

About Fast Trak Services
Cytiva has Fast Trak service centers in the USA, Sweden, India, South Korea and China and satellite Fast Trak Centers in Turkey, Japan and Singapore. The centers are specifically designed to help biopharmaceutical manufacturers increase their process productivity, reduce cost and enable them to bring their product to market faster. Contact us for more information.