In the business world, the mantra “fail fast” is often used to describe an approach where success can be achieved by knowing what to do and when to do it. In that model, risk takers have to be willing to embrace their failures, as a way to determine the path forward quickly. However, applying this model in the pharmaceutical industry can be far too costly when it comes to achieving first-to-market goals. Any delays that slow progress, impact a company’s bottom line, or have regulatory ramifications are going to result in projects that may not make it to market before any competitors’ products, if at all.
Therefore, rather than failing fast, you must figure out a way to succeed as quickly as possible. This requires a comprehensive assessment of your company and its capabilities. In some cases, you may find your company has the in-house resources necessary to do it on your own. In others, though, achieving your goals could require tapping into external expertise that helps save time and gain speed to market.
By checking the pulse of your organization first, it is possible to identify any gaps and develop a plan for how to address them, so you can make the right decisions at the right time. Knowing which path is best for your company and choosing the right partner (when necessary) mitigates risk and accelerates outcomes, moving you faster and further in this highly competitive environment.
Does your business strategy align with your capabilities?
When assessing your organization’s capabilities, you must be brutally honest about its resources and technical and capacity capabilities. Overcommitting in any of these areas can become a liability when you overextend. For example, you may have the technical capabilities but not the resources or the infrastructure, which could ultimately cause bottlenecks. External expertise in certain manufacturing strategies may also be required, such as in single-use technologies.
Capacity and capital: Are you prepared?
One major risk to a company’s supply chain is demand volatility. Underestimating the demand of a product can lead to a drug shortage, preventing patients from receiving what can sometimes be life-saving medication. However, overestimating demand is just as risky, as this can lead to wasted inventory and even lost jobs. Nevertheless, a company must have enough capacity for its drug demand. The decision then becomes: Do you have the capacity and/or capital to control your own manufacturing destiny on your own, or do you need to engage the help of a contract development and manufacturing organization (CDMO)?
If you do not have the financial budget to support building a biomanufacturing facility or a bioprocess train, partnering with another company early can delay any CAPEX investments. Choosing a single-source partner that has access to not only end-to-end biomanufacturing capabilities but also to product development and innovations in biomanufacturing equipment, cell culture media, resins, and single-use devices can increase efficiency and speed to market.
In-house expertise: Are you covered?
In addition, while small to midsize biotech companies may possess an arsenal of brilliant minds, they must have a full wing-to-wing understanding of media development, from discovery through commercialization and scale up. If that knowledge is not available in the early phases, the company will likely spend far too much time and money repeating experimentation. There could be issues later, too, if analytical assessments are not completed properly and the focus is on something like titer instead of on product quality attributes. With the right expertise, you can move forward very quickly with the design of your biomanufacturing process and then dovetail into other critical factors, such as cost of goods and availability of raw materials during scale up.
A thorough understanding of the availability of raw materials is also necessary, or you could find yourself in a situation where you are missing a critical component of your process. This triggers regulatory considerations, which may require additional clinical work to determine the impact. Having products and services in one place with a single-source provider can facilitate troubleshooting any raw material supply issues. There are various types of requirements for import and export, as well as trade barriers in some regions of the world that could affect availability.
Regulatory considerations: Are you compliant?
The nuances between regulatory bodies across the world are often overlooked when determining a company’s ability to work on its own. A formulation has to not only be scalable but also accepted (and approved) by the country’s governing body, whether that be in the U.S. or in an emerging market, such as China. The latter is a particularly challenging area, as it does not allow clinical data to be leveraged globally. Instead, it must be performed again within the country, which can add three to six years of work. You must understand the impact any changes during development can have on not just the final formulation for your drug but also its eventual approval. Compliance should be considered as early as drug discovery, especially in biologic products, as the first-to-market company is the one that ultimately ends up owning that market space. Other companies that follow are at a disadvantage and must then adopt a new strategy, such as discounting their product, in order to be successful.
Overall, it is important to be honest about what internal capabilities exist and whether the necessary skills and resources are available in-house to deliver the intended outcome in a timely manner. If they are not, it makes smart business sense to engage a CDMO, in order to avoid any major failures and/or a longer lead time to market. But what benefits should be expected from this relationship and how do you choose a partner that is right for it?
Considerations for choosing a CDMO
The experience and expertise of a well-established CDMO can offer many benefits, especially if your business strategy is to ultimately control your own manufacturing destiny. Partnering with a CDMO can offer the training necessary to prepare you for that independence. This requires openness and collaboration with teams working openly side by side. If this happens, a CDMO’s team is not just developing the process with you but also sharing the reasons why it is being done a specific way.
Transparency: Does the CDMO foster an open partnership?
An open partnership depends on how the CDMO manages its customer on-site. It is up to you to vet any potential CDMOs and find out how open they are willing to be over the course of the relationship. Ask questions, such as does the CDMO allow both teams to work openly in a pilot plant, or is your team allowed only in specific areas of the building during processing steps? Also, find out what the CDMO intends to provide at the end of the project. Does it provide documentation, such as analytical testing requirements and SOPs, and will it speak openly with you to support it on an ongoing basis, even after the service work is rendered?
Regulatory experience: Is the CDMO prepared for the challenges of global manufacturing?
When it comes to regulatory expertise, a CDMO should have the knowledge necessary to successfully deal with local authorities, particularly in emerging markets. It may even lean on established relationships with regulatory agencies. For example, when developing a process globally, work has to be done very early in the developmental setting to meet the needs of the market in which a company wants to enter. Having an understanding of what level of acceptance there is from the local regulatory agency is imperative. There are different challenges in various regions of the world that expose some of the IP associated with the molecule or the process itself.
Intellectual property: How will the CDMO protect your critical IP?
Additionally, a CDMO should be able to help build a strategy around protecting and preserving that critical intellectual property. It may use a well-established entity to do so. This includes establishing terms and conditions of an agreement all the way through the engineering modifications required to protect any electronic data generated during the process or even security in the laboratory to protect the cell line, such as cameras, physical locks on the bioreactors, and restricted access to cell line storage/cultivation. Another strategy would be to use a black-box approach, where the CDMO does not know what the molecule is, or it may not perform the testing itself. It provides only the development work and then sends the samples back to the customer for any testing. Having a plan to protect IT is especially critical in emerging markets, where there is the potential for differences in legal requirements to leave vital information dangerously vulnerable.
In the end, leveraging service support externally can lessen the risks associated with drug development, such as building an infrastructure, especially if your strategy is based on unpredictable demand. This tightens up cash flow internally prior to having a commitment that a drug product will meet approval in the market space. A single-source partner that is both a service provider and a product developer can give you optimal results in a drug development setting through access to early product innovations and a holistic understanding of the process and equipment requirements. By receiving this kind of insight in advance, you reap the benefits of both worlds, which help you not only go faster to market but also further.
About Fast Trak Services
Cytiva has Fast Trak service centers in the USA, Sweden, India, South Korea and China and satellite Fast Trak Centers in Turkey, Japan and Singapore. The centers are specifically designed to help biopharmaceutical manufacturers increase their process productivity, reduce cost and enable them to bring their product to market faster. Contact us for more information.