Considerations in Biopharmaceutical Outsourcing - Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges. -


Considerations in Biopharmaceutical Outsourcing
Because of the complexity of the manufacturing processes for biologics, transfer of these processes to a contract manufacturer presents challenges.

BioPharm International Supplements
Volume 25, Issue 3, pp. s6-s11


BioPharm: There has been a trend among many large companies to consolidate suppliers. Has your company changed its offerings, or is it considering do so, as a result of this new outsourcing environment?

Zinselmeier (Baxter): We have always had what we considered to be a broad service and technology offering. We proactively looked at those services valued by our clients that enable provider consolidation. We believe there is mutual benefit and efficiency to the preferred provider model and strive to create a portfolio approach that enables clients to use BioPharma Solutions for many projects. The reduction in cost and risk for our clients has been well documented. For example, we have seen one pharma client reducing service providers from more than 60 to five during the past seven years. This has required incredible coordination and commitment to the desired benefit, and seems to be a trend that is accelerating.

Payne (Catalent): We focus on providing integrated services from gene to market and continue to invest/partner in order to expand our offerings. By providing a breadth of solutions, our customers demand we create more valuable relationships with them. Beyond our own innovation efforts, partnering with companies such as CEVEC with their CAP human cell line and Xencor's humanization technology is another way we have expanded the tools available to our customers.

BioPharm: Capacity, and specifically overcapacity of biological API manufacturing, is another hot topic in outsourcing these days. In your experience, how can a CMO best take advantage of potential overcapacity? What key considerations need to be taken into account to remain competitive in this regard?

Payne (Catalent): Our customers are looking for integrated solutions; we do not believe a business model that provides capacity alone will be successful. We have looked to leverage existing capacity in new geographies through partnership in addition to internal capacity expansion efforts.


BioPharm: Are there areas in which outsourced biopharmaceutical services demand continues to exceed supply?

Zinselmeier (Baxter): When considering service demand you also need to include another variant—the timing of the need for that capacity. Ideally, each party would have a robust understanding of future volume requirements and would be able to manage capacity to meet this demand. We all know that is a difficult paradigm to manage. There is often a critical need for capacity in a shortened time horizon, and this creates challenges for all parties and results in a demand imbalance. The manufacturing services space has been especially turbulent this past year, with providers exiting due to financial constraints and regulatory issues. This can create upheaval and is a recent example of the situation mentioned here.

Wolff-Long (Cangene): Areas where demand exceeds supply would perhaps include fill/finish of cytotoxics, and also medium scale syringe filling for small niche drugs, which is a core competency at CBI.

Payne (Catalent): We are expanding in order to meet the increased demand from our GPEx technology customers. Especially in the early development and manufacturing phases, there are more options and less capacity issues.

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