Robust Response to COVID-19 Demand
By Christa Myers, Pharmaceutical Market Sector Lead, CRB | 03.31.20
What it’s going to take to develop, scale-up, and manufacture the products needed to address the COVID-19 outbreak.
Multiple products are undergoing testing for the COVID-19 coronavirus. Each product that shows effectiveness has interesting aspects that must be considered: How much do we need to make, and how quickly can we make it? Some treatments are oral solid dosage forms (tablets, capsules, etc.). Others are injectable drug products. For any of these products, the short-term questions will drive the industry to do things based on expediency. There will also need to be long-term, strategic decisions made to ensure business continuity.
The landscape for the entire pharma industry is changing, and CDMOs (Contract Development Manufacturing Organizations) will be in the spotlight to address both short-term and long-term needs. Development of a suitable vaccine or treatment relies on a close look at the supply chain. For the short term it is essential for each company to specialize in the technologies where they operate the best and outsource to others that excel in a different technology. This will mean that full collaboration across organizations will be needed to research and develop, scale-up, and manufacture the products that will have profound effect on the patients and even the bystanders to the COVID-19 outbreak.
Unbridled enthusiasm for the treatment must be tempered by the truth: It takes time to make and test drug products so that they are safe and effective. A great deal of work must occur to plan a facility so that the product can be produced and filled into the final vial or syringe that shows up in the clinical setting. One of the ways to shorten the duration and provide product sooner is to utilize an existing facility or existing equipment.
Detailed evaluations are used to assess availability and capacity of the process systems, and the support systems within current facilities as well as with partner companies to determine which solutions offer the best timeline for the given production. Mathematical modeling and risk assessments are important tools to evaluate the functional throughput and strengths and weaknesses of each situation being considered. A risk ranking process can be used to succinctly grade the most needed requirements and identify items that could cause cost or schedule issues.
Using existing equipment or and existing facility will often allow for commercialization to occur sooner and will allow for productivity.
In a recent conversation with a general media journalist, I was asked about repurposing existing facilities, and whether a facility already at work on other types of vaccines might be quickly mobilized for coronavirus treatment production. These types of products can be made in a number of ways and the appropriate equipment is not the same across every vaccine. Matching the correct equipment to the process and confirming the throughput capability takes an effort to understand the process and how much “spare” capacity can be found. Companies review the design and mathematical modeling for their facilities and compare that to the new requirements. Often an additional process or partner is needed to finish the product so that it can be sent out as a proper packaged product.
It is not just a matter of asking one facility engaging in one type of work to culture and grow cells for another. Each vaccine is made differently, and changeovers cannot take place overnight. Some pieces of equipment required for even simple repurposing or retrofitting might have a four-to twelve-month procurement lead time – and that may be a conservative estimate, in today’s supply chain landscape.
Many companies find it necessary and effective to rely on CDMOs. Undoubtedly the fastest way to increase capacity is to work with contract development manufacturers. The catch is that many CDMOs are reaching the top limits of their capacities. Finding organizations with capacity may become increasingly challenging as time wears on. Many of the CDMOs have spent time in the past few years upgrading and adding onto their current facilities to meet demands.
Construction and engineering efforts have changed over the years and many companies are leaning towards more lean systems that allow for control of budget and timeline. The project planning and delivery method used to move your project forward has to be thought through, agreed upon, and committed to on a daily basis in order to deliver the right solution at the right time and the right price point. Both CDMOs and companies that manufacture their own products are pushing for the right solution to provide patients with a cost-effective and timely product.
Even in the best of circumstances, it can take years to get from phase one of a vaccine to manufacturing in bulk. To address the current urgency, the industry can expect to see – almost simultaneously – increased retrofitting of existing facilities, increased new facility construction, and increased reliance on CDMOs. To the extent that CDMOs may be the easiest path, there will almost certainly be some upheaval in CDMO plans and processes.
Now, more than ever before, it is essential for organizations to work together, globally, to better understand capacity and how partnering companies can help address the global demand for coronavirus treatment.
Christa Myers is the Pharmaceutical Market Sector Lead for CRB. She can be reached at firstname.lastname@example.org