4 Program Management. In the current competitive climate, managerial competence is equally significant as technological competence. Poor program
management can cause a technologically sound process development project to underperform. Respondents emphasized the importance
of communication, transparency, proactive partnership, and confidentiality.8 An apparent lack of transparency and communication can be enough to instigate distrust and lead to the breakdown of a client–contractor
relationship. This can disqualify the contractor for future projects.
A contractor should appoint a designated project manager responsible for all aspects of the process development project and
reporting progress on a weekly, fortnightly, or even monthly basis. Depending on the client's needs, communications can be
as simple as email updates or may involve more comprehensive systems such as video conferencing or site visits.
Process development projects should be treated as partnerships, with a focus on developing communicative relationships with
clients. This encourages a strong collaboration and assists in solving technical problems, meeting deadlines, and remaining
5 Other Criteria. Other criteria of lesser importance highlighted in the studies include:
Availability of capacity
With the increasing interest in biologics comes an increase in demand for manufacturing services. Survey respondents expressed
a fundamental concern about facing a situation in which their provider does not have sufficient production capacity available
when needed. Clearly, a lack of available resources hampers the delivery of program objectives on time and in budget, and
can eliminate time and cost advantages.
Realistic lead-times to include process development and technology transfer
Technology transfer can appear simple on paper, but in practice, it can be difficult to execute. Technology transfer is often
regarded as a process that just happens. However, whether it is a case of an in-house scale-up or a transfer to a third party
manufacturer, technology transfer can confer a competitive advantage if it is given due planning and attention. Significant
reductions in both time and cost can be realized.
Cultural fit and overall attitude
Cultural fit and overall attitude are questions of confidence and trust. If one company has misgivings about the other, it
can be to the detriment of the developing biologic. A strong focus on communication and transparency can go a long way to
bridge cultural gaps and build successful client–contractor relationships.
Surprisingly, close proximity of the contractor repeatedly rates low. It appears companies are far more interested in the
contractor's technical capability. If real synergism exists, there is an overall willingness to deal with contractors afar.
In conclusion, biopharmaceutical companies are becoming more sophisticated and flexible in their business operations so that
they can remain competitive. Because industry trends indicate the need for reduced COGS, a key competitive advantage lies
in process development. Companies are becoming increasingly aware that a more pragmatic way to keep pace with new technologies
and platforms is to access them through outsourcing rather than attempting to build these capabilities internally. Under-used
in-house resources are costly, and it simply does not make strategic sense to have resources idle when capacity and expertise
can be purchased through outsourcing. Instead, the biopharmaceutical company can refocus asset use on core competencies.
Outsourcing process development is becoming a rational long-term strategy that is integral to biomanufacturing. A thorough
screening of prospective process development contractors can result in a highly beneficial contractor–client partnership with
handsome dividends for the process development investment.
Stephanie Morris is scientific and marketing support for protEcol Services at Hospira, Adelaide, Australia, +61 8.8234.2660, email@example.com