The Case for Outsourcing Biologics Process Development - Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider. - BioPharm International

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The Case for Outsourcing Biologics Process Development
Four reasons why outsourcing may be the best option, and key factors to consider when selecting a provider.


BioPharm International
Volume 21, Issue 12


Figure 1. Throughout the manufacturing steps (plasmid construction through regulatory compliance) involved in manufacturing a biologic expressed in E. Coli, specific expertise is required at a number of varying stages during the manufacturing strategy. The skills sets such as molecular biologist, process engineer, and regulatory manager are needed for shorter, definite intervals, whereas the collective skill sets (shown in ovals) are required on a more lengthy basis, possibly even throughout the entire duration of the manufacturing program (depending on the program).
Consider the manufacturing streams for biologics expressed in E. coli: plasmid construction, cell transformation, fermentation, protein recovery, refolding, purification, analytical evaluation, validation, engineering, and regulatory compliance (Figure 1). Each of these areas requires specific expertise and professional skill sets, although not necessarily equally nor concurrently. How does a company manage this quandary, retaining both professionals and supporting infrastructure?

By outsourcing, an organization can gain access to an entire complement of skill sets like these, as well as to new generation or proprietary technologies, all the while reducing overall developmental risk. Outsourcing offers flexibility, allowing the organization to refocus asset utilization on its own core competencies, saving time, money, and potential heartache.

FACTORS IN OUTSOURCING PROCESS DEVELOPMENT

At Hospira, we have identified important factors that organizations contemplate when determining whether their operations will benefit from outsourcing process development.

Economic Efficiency and Opportunity Cost

Resource mismanagement and production inefficiency can have long-term, detrimental effects on investor confidence. Maximum economic efficiency is key to a healthy ROI.

Economic efficiency embodies both allocative and production efficiency. Allocative efficiency is the allocation of resources to the products most desired, and production efficiency is the adoption of least costly production techniques. Operating outside the realms of maximum efficiencies, and thus comparative advantage, is damaging and unsustainable. Opportunity cost is therefore an important consideration when deciding whether to outsource.

Reduction in COGS

Compared with the manufacture of small molecules, the manufacture of biologics is eminently labor intensive, very technical, more costly, and inefficient.6 At Hospira, we have determined two key elements that drive the COGS for biologics: molecular complexity and quantity required.

Protein length and sequence affect yield and purification efficiency whereas quantity requirements affect the scale of production. Each factor ultimately determines the choice of production systems, e.g., chemical synthesis or recombinant manufacture, or bacterial or mammalian-based expression systems. Production processes will also inevitably evolve as developmental requirements change.

A company needs to decide if it is capable of supporting the necessary production systems, taking into consideration compliance issues. Process development contractors are using innovative, state-of-the art manufacturing technologies to expand production capabilities and efficiencies. As such, the industry is seeing an array of new proprietary technologies, particularly those having significant effects on production yields and protein purities. Amateur production is no longer realistic.


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