Outsourcing vaccine development and manufacture
As described, the complexity of vaccines creates a unique set of challenges during process and product development. Within
a portfolio of vaccines, there may be a wide range of products, each requiring different production technologies—viral, microbial,
and mammalian. Very few CMOs have the expertise and facilities required for all these technologies, meaning that vaccine developers
must manage multiple vendors, relationships, and locations to progress development of their vaccine portfolio.
Companies outsourcing mAb production enjoy a reasonable mutual confidence that a small-scale in-house developed process can
be transferred to a variety of CMOs for scale-up. In contrast, vaccine developers will typically need to engage with CMOs
earlier in development to avoid the possibility of transfer issues at a later stage. In addition to specific manufacturing
capabilities, it is necessary to find a CMO that can provide expertise in a range of ancillary functions such as characterization
and formulation, as described above. Outsourced fill and finish of vaccines can also be challenging, as very few contract
service providers have the capability to formulate and fill live bacterial or viral vaccines.
With the above considerations in mind, many vaccine developers have chosen to establish their own facilities. We argue, however,
that this can represent considerable commercial risk and a deployment of capital that might otherwise be used to expand product
development portfolios. In many cases, well-managed outsourcing of vaccine development provides manufacturers with opportunities
to accelerate speed to market, mitigates their risk, and provides task-specific technical and regulatory expertise that is
otherwise expensive to hire and retain. Effective outsourced vaccine development is achievable as long as the right partners
are chosen and the relationship is well managed. The following are a few recommendations to consider when choosing and working
with a CMO during vaccine development (11):
Develop a request for proposal (RFP) that includes:
- Comprehensive information about your product and any existing process (e.g., molecular characteristics, cell line to be used,
analytical methods used for testing)
- Information about your project, including estimated time line, production scale required, how much material will need to be
delivered, stage of product life cycle (i.e., preclinical, Phase III, etc)
- A delivery date for the proposal
We recommend that you contact at least three CMOs to provide proposals to compare capabilities, capacity, quality systems,
project management, and pricing. It will be necessary to establish Confidentiality Disclosure Agreements (CDAs) to continue
to share more detailed information.
Shortlist to CMOs that have:
- Experience with product classes that are the same as or similar to the composition of your vaccine.
- A successful track record in guiding biopharmaceuticals through all phases of clinical development and an associated in-depth
understanding of the technical and global regulatory challenges to be faced.
- A compliant and validated facility, with appropriate equipment at the scale needed to complete the project in a timely manner
and at a reasonable price.
- Available facility space in a timeframe that supports your project time lines. A flexible production schedule is beneficial,
especially during early development when time lines are not easy to predict
- A scale of operation that will grow with your product, either in-house or through chosen third parties throughout the supply
- Enabling technology that is appropriate for your product and an established network of qualified third-party vendors who can
support activities (e.g., execution of advanced analytical methods, fill/finish) that will contribute to the overall project.
- Quality systems/regulatory accreditation in place (as appropriate for the phase of development and manufacturing).
- An established project management system, with experienced project management staff who can work with scientists and quality
experts to manage deliverables, communication between the CMO staff and the client and well-defined project milestones
- A clear and transparent intellectual property position and mechanisms to ensure confidentiality as well as data security.
- Formalized technology transfer/risk assessment processes.
It is very important to understand the CMO well and, where possible, to meet the people who could potentially perform your
development project before you start your project. This provides an opportunity to understand not only the technical capabilities,
but also the corporate culture, company organization, and the company's approach to clients. Following a quality systems and
facility audit, you will be in a position to choose a CMO that best fits your criteria, timeline and budget.