HOW TO DECIDE
When deciding whether to build your own capacity or buy it from a CMO, prioritization of what is most important to you as
a company should be key. Although your available budget and the return on investment must be considered, your choice shouldn't
be made on potential costs alone. Several factors should be weighed before you make your choice:
- Risk tolerance: Are you willing to put some (or all) of the responsibility for product development and manufacturing into the hands of a
- People/expertise/core competencies: Can you assemble a team to execute various project tasks, or do you require support from an external source for things like
basic process development and manufacturing, or for specialized activities like fill-and-finish?
- Manufacturing scale and production forecast: How much of your product will you need to complete your clinical trials or to support commercial demand? Will your company
have available capacity at the proper production scale to meet your needs?
- Technology: What technologies will be required to manufacture, test, and finish your product? Do you already have the appropriate science
and equipment in place? Do you have the budget and time to obtain the required technology, or is partnering with a CMO the
- Timelines: Is there pressure from investors or the market to achieve a clinical or commercial milestone by a particular date? How will
the required project tasks fit with the expected timeline? Will building or retrofitting a facility fit with the timeline,
or do you need to use a CMO to achieve your milestones?
- Geography/cultures/currencies/ communication: Does closer necessarily mean better? Are currency exchange rates critical to your project budget? Are you prepared to communicate
across various time zones and possibly cultural influences?
- Regulatory affairs (RA)/clinical sites: What is your target market and will you need to include several locations around the globe in your plan to submit a regulatory
filing? Do you need to have your own facility and RA staff in the same location as the clinical sites? Is there a CMO out
there that can fully support your regulatory plans?
- Intellectual property/control: Does your company wish to control its IP completely, or are you willing to share your know-how with a trusted CMO partner?
Will you grant a license to a business partner who will take your product through to commercialization, or do you prefer to
maintain control, including manufacturing, throughout the product's lifecycle?
- Number of products and their development/clinical phase: You should plan for success, but the "what ifs" of failure also need to be considered. Do you have one or two products in
the early phase of development, or is your portfolio well balanced with products in all stages of clinical development and
clinical trials? It does not make sense to build a new facility if your pipeline cannot support it.
GREENFIELD OR RETROFIT?
If you have the option to build a facility from scratch ("greenfield") or to retrofit an existing space, you must carefully
scrutinize what is available to support the production of your product. A greenfield facility will be fit for purpose from
the beginning, but various challenges may arise for a company that choses to build, including keeping to the construction
budget and timeline; employing people with the proper background to ensure that the facility is fit for purpose; and training
staff to install, validate, and operate equipment. On the other hand, it may be more difficult to retrofit an existing space
because the existing space must be able to accommodate the new equipment while perhaps maintaining (and re-validating) some
of the legacy infrastructure (e.g., clean-in-place and steam-in-place skids, utilities, tanks, water supply). Any compromises
in facility design will need to be weighed against planned production and regulatory requirements.
If you do decide to build, consider that there are several manufacturing technologies to choose from:
- Disposable, single-use, or limited-use manufacturing equipment: Some of the benefits of these components and systems include a low initial capital outlay, fast installation, and reduced
routine operating costs, because these can reduce or eliminate the requirement for cleaning or cleaning validation. Although
the use of a completely disposable production train is not common, biotechnology companies are beginning to investigate this
as an option.4 For particular types of products such as viral vaccines, disposables are indispensable.
- Stainless-steel systems only: Stainless-steel systems are proven for manufacturing products reliably and reproducibly; the technology is common, so process
transfer between manufacturing sites (internal and external) is relatively straightforward, and these systems can support
various types of products. But consideration should be given to budget and timeline requirements for installation because
they tend to be expensive and time-consuming to order, install, and validate. Cleaning will be a continuous challenge for
the lifetime of the system.
- Hybrid systems consisting of disposable and stainless-steel components: This option seems to be the most popular for manufacturing biopharmaceutical products.4 Systems can be designed to meet your facility and product requirements, using a "best of both worlds" approach.
Before making your decision to build or retrofit, consider that regardless of the equipment you choose to install, maintenance
and materials supply will be a continuous endeavor. Planning for time and costs to operate and maintain these systems should
be included in your overall product lifecycle design.