Q&A with Dr. Athenecia Faggins: Practical Challenges in Raw Material Management for Advanced Therapies

At the PDA/FDA Joint Regulatory Conference 2026, Athenecia Faggins, director of analytical sciences at Minaris Advanced Therapies, spoke during the session “Practical Challenges and Solutions in Raw Material Management” on Tuesday, September 15, 2026. After her presentation, Dr. Faggins sat down with BioPharm International® to further discuss the challenges associated with raw materials used in advanced therapies, including supplier qualification, research-use-only materials, testing requirements, and the potential impact of raw material decisions on product availability.

What makes raw materials particularly challenging for advanced therapy manufacturing?

Faggins: The primary thing that makes it challenging is the difference between advanced therapy products and traditional medicinal products. When we think about the raw materials that are used for traditional medicinal therapies, we think about chemistry. But when we think about raw materials that are used for advanced therapy products, it’s not chemistry. It’s biology.

We’re working with living cells potentially. We’re working with human blood as a starting material, cells, or tissues. That changes the relationship between those materials and, therefore, changes the way you need to approach them, how you evaluate them, how you control them, and how you establish and maintain the state of control.

That is going to look very different for biologics as opposed to a standard therapy. The key is the relationship between the materials and their ability to impact the quality of the product. Those profiles are different.

Where do manufacturers most often run into problems when sourcing and qualifying raw materials?

Faggins: I would say finding materials that meet the quality needs of a certain product or process.

For example, a very common material, such as PBS or L-glutamine for a cell culture process, may have multiple suppliers. It’s not hard to get. But maybe one manufacturer has a certificate of analysis where they test for sterility and everything else is for information only. Another supplier may issue a certificate of analysis with specifications for endotoxin, pH, or osmolarity.

You want to look at the level of rigor that is applied to the release of the materials from each manufacturer. First and foremost, you want to consider the level of transparency that manufacturer is willing to have with you. Are they willing to provide representative certificates of analysis and BSE/TSE statements for you to evaluate that material before you purchase it?

Those are all critical things that are needed in order to get to a qualified state for your materials. You need a supplier that is going to meet your quality needs and provide you with the information you need for appropriate evaluation.

How should companies approach single-source or research-use-only materials when alternatives are limited?

Faggins: When it comes to single-source materials, you have to have a relationship with that supplier. You can’t just be customer A on a sheet of paper. That supplier needs to understand your need and the urgency of that need, and they need to be willing to work with you to ensure that your supply meets your need.

When it comes to research-use-only materials, I would say it’s critical to have a plan in place to progress to that GMP material. If that is not an option, your plan needs to be how you progressively increase your level of stringency to achieve a level of risk mitigation that’s appropriate for use of that RUO material.

You need to upgrade it as soon as possible, but if that is not an option, you need to assess and understand the specific risks that it poses and be able to mitigate them.

What should manufacturers look for when qualifying and managing raw material suppliers?

Faggins: You need to ensure that suppliers have sufficiently robust quality management systems in place.

Are the raw materials being manufactured under adequate controls? Are they being released in a consistent and documented manner? Are they generating the appropriate quality documents to support these materials, such as the certificate of analysis and BSE/TSE statement? Do they have data on validation and stability?

First and foremost, you need to ensure that the manufacturers of your raw materials are doing their due diligence within their quality system to adequately control the manufacturing and release of those materials.

Then I bring forward the other points, including transparency, being able to provide appropriate documentation for you to evaluate the suitability of those materials, and meeting the quality needs of your product through adequate specifications for release presented on the certificate of analysis.

How can raw material decisions affect the quality and consistency of an advanced therapy?

Faggins: Raw material decisions can lead to a failure of a batch, delay of a batch, or inability to execute production of a batch. All of those scenarios can lead to a finished product or a treatment not being available to a patient.

Advanced modality therapies are generally treating patients with poor prognoses who have few other options for treatment. If we take autologous therapies as an example, you’re getting a fresh leukapheresis product from a patient who needs that finished material back for their treatment. They can’t reproduce that starting material.

Poor decisions related to raw materials potentially lead to not being able to deliver that treatment back to a patient, and so that is the severity of it. Does every scenario rise to that level of risk? Maybe not. But I think we need to consider that in all cases. That is the absolute worst-case scenario.

How do we eliminate that from possibility? That is how critical I view the decisions made related to raw material selection and control, and ultimately making those decisions consistently.

What is one raw material issue companies should be thinking about much earlier in development?

Faggins: That’s easy. Testing. Testing, and it’s not because I’m from analytical sciences.

In my experience, the biggest hurdle to GMP readiness has been not having the appropriate tests in place and not allowing the time to develop and maybe qualify those tests. When we leave the consideration for testing until the last minute, we’re leaving the time on the table to prepare.

It’s not to say that you need to start testing as soon as possible. You need to know what testing you need available to you as soon as possible. You need to know if you need to develop or outsource assays. You need to know if existing assays need to be qualified.

Those things take time. That time can be spent in parallel with your process development, your verification, your piloting, or whatever you’re doing.

Leaving that thought and decision-making until the 11th hour, I’ve actually seen it completely tank a program. You can’t proceed if you can’t test your materials. You have to release them.

As soon as possible in process development, you should be thinking about what your testing requirements will be.

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