In BPI’s 5 October 2016 webcast, Paul Jorjorian (director of global technology transfer at Patheon) discussed his top five considerations for companies outsourcing to a biomanufacturing partner.
Jorjorian’s Presentation
Selecting a contract and development manufacturing organization (CDMO) is an important decision for many biopharmaceutical companies. Beyond time and cost, here are some other criteria to consider.
The number-one issue is quality. Is your company’s definition of quality the same as a CDMOs — and if not, how do those definitions differ? Here are three main discussion points: understanding how a CDMO addresses deviations; creating a quality agreement; and determining who is responsible for making, reviewing, and approving required documents.
The second consideration is technical expertise. Does a CDMO’s technical expertise fit your needs? Examples include experience with the different phases of drug development, process characterization studies, recombinant or fusion proteins, monoclonal antibodies, single-use technologies, perfusion processing, unique downstream technologies, and multiplexing. You also will want to know how many years of experience a CDMO has with such technologies.
Third comes flexibility. Uncertain forecasts can require adjusting the amount of product made, so find out how quickly a CDMO can increase or decrease its capacity. Also consider whether you are producing only phase 1 material or need your partner to work from development through commercialization. You might want one CDMO that can do everything or multiple partners, each specializing in certain activities that your company oversees.
The fourth consideration is a company’s proven track record with different types of molecules and technologies. A CDMO should provide concrete examples of past successes, contamination rates, the number of batches it has produced per year, and the percentage delivered on time.
Trust is the final consideration. This might include cultural alignment of how two companies approach solutions. Start by looking at a CDMO’s industry reputation, and ask your network about potential partners. It is critical to make site visits and meet in person.
Questions and Answers
After signing up with a CDMO, what can a client do to help ensure success? It is critical to have that face-to-face meeting. Any time we’ve foregone that meeting, for whatever reason, we end up wasting time and spending more than flying out to the facility would have cost. Getting project teams aligned and allowing subject-matter experts to meet upfront is critical. It is much easier to communicate with someone you’ve interfaced with directly.
What are the most common causes of failures during a CDMO project? Many errors and issues manifest themselves very early. Think about launching a rocket to the moon: If you are one centimeter off when you launch the rocket, then you can be really far off by the time you reach your destination. It is similar with these programs. You must get your teams aligned and clearly define expectations: on how data are presented, how documents are reviewed, and how deviations are managed. Also define expectations for timeline, delivery, and review cycles. Get all of that locked down early in the program, defining both sides’ roles and responsibilities.
Quality program management also is important. You need program managers on both sides steering the boat so everyone paddles in the same direction.
When should clients send a person to the CDMO? A person-in-plant can be sent multiple times to support initial program development, to work with a scientist in the development laboratory, or to provide support on the manufacturing floor. We find development interactions to be helpful, especially if a client has developed its own process. Process information is not always easily translatable in a Word document or a PowerPoint presentation.
The other thing we’ve found helpful is sending people from the CDMO to the innovator’s site to see a process run in the original lab or pilot plant. This can save time as a program progresses.
There are pros and cons to having person-in-plant support. It is good to have someone there to answer questions, especially if it is the first time a program has scaled up. The innovator company’s expert can provide professional and timely insights as a batch is being executed. But too many individuals from the sponsor company on site can become a distraction. A nice balance comes with having the innovator company on site providing technical guidance as a program is running.
Find More Online
The full presentation of this webcast can be found on in our multimedia section.
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