About 15 years ago, I was a project management director responsible for moving monoclonal antibodies (MABs) from Phase III clinical to commercial manufacturing. I had the distinct pleasure of working on two new molecular entities (NMEs) at a top-tier biotech company with currently marketed products treating rheumatoid arthritis and plaque psoriasis.
Fast forward a decade plus and, now in a QA role, I still reflect on learnings from that experience through the quality optic. Given the current challenges and opportunities presented by COVID-19, these are more relevant than ever. This reflection on best practices led me to use a helpful cause and effect approach: 6M.
6M categorizes factors in cause and effect analysis so that readers can understand them better. As many investigative professionals know, 6M stands for manpower, machinery, materials, methods, measurement, and mother nature (environment). For this review, let’s take a closer look at methods, mother nature (environment), and manpower.
Note: for those that love reference material, ICH10 provides a succinct overview of the product lifecycle development and the importance of quality systems throughout the process of product development.
The facility, utility, and process comparability between R&D and Manufacturing (facilities’ stability and functionality) must be comprehensive and well documented. Of course, this is done in advance of the actual tech transfer, but is an important step nonetheless.
The methods with the tech transfer process must be project management office (PMO) driven, and from my experience, with no exceptions. It requires dedicated project managers (PMs) with the requisite knowledge, training, and education for the task. It also requires Project Management Body of Knowledge (PMBOK) style rigidity: kick-off meetings and RACI diagrams to know who is responsible, accountable, consulted, and/or informed. In other words, there must be clear roles and responsibilities.
There must be issue escalation models for problem resolution. After action reports
(AARs) and full, transparent relationships with R&D should be considered the norm, not the exception. That means all documents, methods, and tribal knowledge must be fully vetted prior to the transfer. There can be no “R&D during or after transfer.”
Decisions must be team-based and strive for consensus. Of course, in the end, the project lead may have to make “the call.” That’s OK—just document the process, usually with a risk assessment. With regard to the PMs (and I love PMs): they have diplomatic immunity. They are given safe passage and are not susceptible to prosecution. They don’t have to make people happy; they have to stay on or ahead of schedule!
In our current COVID-19 environment, methods have certainly been forced to change. Think about the challenge of physically auditing your suppliers and their methods. We have seen a massive shift to virtual auditing and the challenge of auditing suppliers has been successfully conquered!
Mother Nature (Environment)
Although Mother Nature can impact a successful tech transfer (nothing like a good power outage), I would like to take a look at the actual environment of the tech transfer team. It is important and probably the most controversial issue we deal with during the project organization process. People ask: Where will the team meet? Are they temporarily assigned? Do they keep their “day jobs”? Location constraints include a place with easy access for most, though we know we cannot accommodate all individual desires. The answer: colocation. We move the entire team to an open-concept workspace with no walls.
It solves the challenges of getting the techs/chemists off the floor and getting managers and directors out of their cozy offices. Employees are 100% dedicated to the project with very few exceptions. It is difficult in the beginning but enormously successful throughout the project.
As for workspace, pick the best location on site. In 6M terminology: temperature, humidity, noise disturbance, vibrancy, lighting, and indoor pollution must be at the desirable levels. Why? The end result is that the best people in the organization want to work on a tech transfer project because the team is incentivized with desirable location, environment, decision-making capacity, and premier visibility within the organization.
In the COVID-19 universe, this again has moved to a virtual setting. Colocation has become a virtual platform with any number of electronic platforms. Rather than commanding a conference room at the manufacturing site, we are in our home offices and the colocation challenge is met quite successfully.
So, with all that done, how do you pick the right people to work on the project? Always, always pick the best in the organization with few exceptions. This means the best techs, chemists, managers, and directors—the personnel that have the best technology proficiency and experience that meet and exceed expectations. Case in point: our best manufacturing technical expert was the department director. Did that decision have temporary impact on day-to-day operations? You bet. Solution: Allow other promising stars to rise. The associate director and manager filled the gap.
With new COVID-19 challenges, the best people must be assigned to the tech transfer. Those people, or at least many of them, need to be able to work in the manufacturing, R&D, and QC areas. As leaders, we need to make sure personal protective protocols are in place to protect our valuable resources. Organizations have overwhelmingly met this challenge and, as a result, novel therapeutics are being launched.
In terms of Stephen Covey’s philosophy (and beginning with the end in mind), for a successful tech transfer, I ask: What do we want the conclusion of a tech transfer to look like? The answer: A robust, repeatable, well planned, transfer of product from R&D to a commercial facility using the most talented people in the organization.
With these best practices in place, in my personal experience, the result was a successful project. Each transfer was about 18 months in duration and at the end of the transfer project, the team did not want to disband. If you have ever been part of a tech transfer, I think you’ll agree – that’s pretty amazing.
Meeting the challenge of a tech transfer can be daunting, especially in our current COVID-19 environment. With talented project managers, scientists, and production experts to guide you through the complete process, ProPharma Group will help you successfully transfer your product from clinical to commercial operations. Contact us to connect with our experts, and learn how we can lead your team to success!
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