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


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

Technical and Operational Capabilities

The accreditation of an external contractor provides assurance of its quality systems and implies operational expertise. A vigilant company may also perform its own quality audit and validate technical competencies.

Consideration should be given to the range and depth of complementary services the external contractor can offer. For example, can the contractor supply material for both clinical studies and commercial requirements? Does the contractor have fill/finish capabilities? There is a growing trend toward dealing with only one company for an array of services, which can result in numerous benefits and considerable savings. Not only does the company's bargaining power increase ("the more you buy, the more you save"), it also avoids the need for multiple technology transfers. The contractor also becomes more familiar with the developing product, encouraging a stronger affinity with the developmental program.

Strategic Fit and Developmental Risk Mitigation

Risk management can be critical to a biologic's developmental success. Biopharmaceutical development is considered one of the more formidable risk management climates to be operating in.7 Drug development is highly regulated, costly, and lengthy, particularly given the low success rates.

By outsourcing, the company can leverage the contractor's experience, significantly reducing developmental risk. Because many regulatory bodies now dictate that risk-management strategies be implemented, a prudent company may opt to collaborate with relevant, experienced experts to formulate a robust and successful risk management strategy.

Criteria for Selecting an External Contractor

Many have surveyed organizations worldwide to ascertain the attributes sought when selecting an external contractor. At Hospira, we continue to survey clients as part of our real-time performance management. Our respondents exemplify current opinions as reported by commercial market reports. Although the exact order of criteria varies, the following issues are repeatedly regarded as the most important.8–12

1 Technical Ability and Reputation of the Contractor. A significantly weighty criterion is the contractor's technical ability, experience, and reputation. This extends not only to biotechnology capabilities and expertise of staff, but also includes experience and familiarity with regulatory agencies and similar policies. 8,9

Figure 2. Alignment of contractor services with a development strategy
Figure 2 summarizes how a range of manufacturing services align with a particular phase of a typical development strategy. A proven background of providing pertinent assistance is important, demonstrating excellence, quality, and technical aptitude.

Intellectual Property (IP), novel technologies, and healthy patent portfolios owned by the contractor confers competence. Such IP can also be leveraged by the developing organizations to augment their own IP position, provided that access to IP is relatively simple and transparent. A simple way to address this question is to examine past case studies, noting a track record in excellence and quality, technical aptitude, and use of modern technologies.

2 Price and ROI. The manufacture of biologics is a customized undertaking. It generally requires more time and financial commitment earlier in the development cycle than traditionally seen in the manufacture of small molecules. However, not only does price reflect project complexity, it is also representative of a contractor's expertise, capacity utilization, and the bargaining position of both contracting parties. Commonly, a contractor is selected because it has demonstrated the cost effectiveness of its services.

Some contractors are now offering an alternative approach to full-scale process development studies for recombinant biologics. Contractors divide process development into sequential modules, each incorporating a defined "go–no go" end point. With this approach, an organization need only undertake one module at a time, offering a more flexible and cost-effective development program.

3 Schedule Compliance and Flexibility. A portion of survey respondents indicated that time management and schedule compliance are critical when selecting an external contractor. Meeting deadlines and milestones can be imperative to a program's success; therefore, a contractor must be capable of keeping timeline commitments. It requires that the contractor be a well organized, flexible service provider with optimal infrastructure administration.

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