Once the CMO is chosen.
The most successful outsourcing relationships are ones in which the project goals are clear from the outset, and open communication
is maintained throughout. During initial start-up meetings, it is important to establish and agree upon the deliverables and
success factors of both parties. These meetings also provide an opportunity to build a good rapport with the members of your
project team and solidify a good working relationship from day one.
- Establish a full project scope-of-work, inducing key deliverables and milestones
- Determine the baseline fee schedule and timeline and agree to terms and conditions
- Establish a suitable quality agreement
- Agree on method(s) of communication (email, teleconference, face-to-face meetings) and frequency; determine points of contact
for these communications
- Determine preferred format of development reports/manufacturing instructions etc, or review CMOs standard templates to ensure
they are suitable for your requirements
- Confirm project kick-off date, and once all documents are in place, start the project.
Progression and completion of the project:
- Request experimental designs that explain how the deliverables in the scope of work will be achieved.
- Where required, transfer your process/analytical methods to the CMO. We recommend a "person in plant" arrangement wherever
possible, as this allows any product-specific nuances to be readily communicated and facilitates rapid feedback, decision-making,
and document sign-off.
- Communication throughout the project should be based upon the agreed formula, with any "out of the ordinary" occurrences or
questions addressed as soon as possible.
- Request routine checks of the project progression against the baselines; generally the Client and the CMO's project manager
will manage this activity.
- Delivery of development reports or CGMP product, including supporting documentation that can be applied to the regulatory
filing (e.g., IND, NDA, BLA, MAA), depending on the stage of the project and product type.
Demand for the development of processes to manufacture novel and established vaccines is currently very high. The authors
have explored how new technologies and experienced CMOs are expediting and adding value during vaccine development.
Although the vaccine industry has been hesitant to adopt enabling technologies in the past, particularly novel expression
systems, economic, and regulatory influences are encouraging vaccine developers to embrace cutting-edge scientific alternatives
and to realize some of the operational and regulatory benefits enjoyed by mAb developers.
The requirement for specialized manufacturing capabilities and regulatory experience are reasons that companies have traditionally
been reluctant to outsource vaccine development, preferring rather to establish their own facilities. We argue that this represents
considerable commercial risk and uses capital that might otherwise be used to expand product portfolios. We argue that vaccine
developers should consider well-managed outsourced vaccine development.
Effective outsourced vaccine development can be achieved as long as the right partners are chosen and the relationship is
well managed. To take full advantage of new technological advances and innovative strategic approaches now creating opportunities,
vaccine developers must carefully evaluate CMOs and select only those that can provide expertise across a range of ancillary
functions. Ideally, the CMO will be able to manage a wide range of products and different technologies such as viral, microbial,
and mammalian production—and will have the manufacturing facilities required to manage a diverse vaccine portfolio.
In addition to having appropriate technical expertise and facilities, however, the complexities of vaccine development when
compared with many therapeutic biologics demand that your selected CMO is well experienced in vaccine development and can
therefore offer the necessary vaccine-specific regulatory support and guidance. Working with a carefully chosen CMO and maintaining
a strong relationship from bench to market provides opportunities to accelerate vaccine development, mitigates risk, and provides
the technical and regulatory expertise that is otherwise expensive to obtain.
Phil Ball, PhD, is a technical director, and Maria Lusk is director of client management, both at Eden BioDesign, email@example.com