To ensure our team at Bioprocess Online stays focused on the issues, topics, trends, challenges, and regulations that are most important to our readers, we have put together an editorial board comprised of some of the industry’s most knowledgeable experts in a variety of areas in the biomanufacturing space. We will be consulting the members of this board for editorial ideas, expertise, and content, in order to put forth the best effort possible to make Bioprocess Online an even more valuable industry resource.
I recently spoke with one of our members, Dr. Firelli Alonso-Caplen, Senior Director, BioTherapeutics & Vaccines Outsourcing, at Pfizer, about the challenges she faces in her role and where she sees the future of single-use technology.
Trisha Gladd: Can you tell me about your role and responsibilities?
Dr. Firelli Alonso-Caplen: My group is responsible for sourcing of just about anything—sourcing of drug substance, drug product, analytical methods, process development, method development, formulation development, as well as some of the intermediates, like peptides, linkers, and adjuvants. This is all to support our division, the BioTherapeutics Pharmaceutical Sciences. Its portfolio covers all aspects, from development through Phase III clinical supply production and testing.
We're the liaison between, for example, a Process Development group and the CMO. We facilitate contract preparation and execution, but we are not Procurement. We have a Procurement and Legal support, and they help us with Requests for Information and Requests for Proposals.
Gladd: With all those people involved, what does the decision-making process look like?
Alonso-Caplen: It's a team decision. We're empowered to make decisions. That really helps. For instance, the team knows what the available budget and timeline are, and those are parts of the decision-making process.
Gladd: What kind of background and education does someone need to be an Outsourcing specialist?
Alonso-Caplen: For my group, I look for people who have a background in not just science and business but also project management skills. The latter is quite important, since my group not only manages contracts with vendors through completion, but also functions as project managers and as single points-of-contact between the Pfizer team and the contractor’s team. More importantly, someone who has the “soft” skills to ensure smooth vendor-client relationship is essential to be part of my group.
Gladd: What are some of the biggest challenges you face in your role?
Alonso-Caplen: Currently, there aren’t a lot of partners available to support manufacture and testing of Antibody Drug Conjugates (ADCs). Eventually, that will pick up, because I know more and more CMOs and CROs are getting into the field, but there are very few of them right now. However, that happened with monoclonal antibodies as well, but it will eventually build up to meet the demand. The other area also picking up now is cell immunotherapy. That's new for Pfizer, and so we're just starting to look for vendors there.
Internally, one of the challenges I face is a demand for externalizing a project without a lot of time. It's always just the typical timeframe and then they change their mind. That's the flexibility – and I call it flexibility in a positive way – in the R&D space, as opposed to commercial. Commercial is more set; you can forecast more readily.
Gladd: What are some best practices you recommend that can help overcome these challenges?
Alonso-Caplen: For the flexibility part, our best practice is really to be proactive with getting contractors, CMOs, and CROs qualified. When I say qualified, it means we put them “through the wringer,” so to speak. Other than just the standard Confidentiality Agreement, we have to have done what we call a Technical Evaluation, as well as a Gap Analysis and a GMP Audit by our vendor auditors. That's part of our exhaustive qualification process. If the contractor is to do GMP work, then a Quality Agreement will also need to be completed in advance. If we can get potential contractors qualified ahead of when someone will come to us and say, “I need this outsourced,” then that really helps mitigate the issue we have with not having a lot of time to find vendors.
Gladd: What do you look for when selecting a partner?
Alonso-Caplen: We have what we call our parameters for externalization. The first parameter is quality. A lot of what we do—I would say maybe 80 percent of what we do—is GMP production and GMP testing, so we have to make sure that we do qualify the vendors we use. We have what we call our Sterility Assurance Assessment, which is sometimes a two- to three-day audit by our expert auditors. Since it’s an aseptic process, being the final material that goes to patients, even if it's Phase I, it has to be compliant with the strict GMPs because it's a sterile product.
The other area we look for is expertise. There are certain CMOs that we go to, let's say, for microbial fermentation, because it makes it so much easier to do a tech transfer, for instance, if that was what we wanted to do. This is opposed to a vendor that's an expert in mammalian work, and so on, or in ADCs. That expedites that transfer.
Cost, of course, we do look at, although I can tell you, cost is really not a primary driver for us in the R&D space. More importantly, we also have to look at whether or not they can fit our schedule or our timeline.
The other thing that we look at is what we call adaptability, which you do not find with commercial contractors, because like I said, for them, it's fixed. Everything is easily forecasted, there's so many batches and so on. For us, we can change our minds, and we've had cases where we've said we're going to be transferring by a certain date, and the scientists are not ready, so that's for my group to manage. Basically, we're like the complaint department and the relationship department all rolled into one.
Gladd: How involved do you get when deciding what equipment's going to be used?
Alonso-Caplen: It's really the Subject Matter Experts that make that decision. Typically, the team is always a cross-functional team, so there's always somebody from Process Development, be it for drug substance or drug product, there's always somebody from Analytics, and there's always somebody from Quality. That's the core team. Then the Outsourcing specialist is basically the project manager for that team. Occasionally, on an ad hoc basis, we invite a Regulatory Affairs person into the team. It depends, of course. If it's not GMP, then there's no need for somebody from Regulatory Affairs to be there because there’s no need to do a regulatory submission.
Gladd: What's your opinion on single use technologies in the biotherapeutic and vaccine area?
Alonso-Caplen: Most CMOs are multi-product facilities, and single-use makes it so much easier, from a cleaning standpoint, that you don't have to do cleaning verification or validation. More importantly, we do occasionally have viral projects that we outsource. Again, that's really a great addition to have single use technology, just to guard against potential for cross contamination.
I think it has also resulted in more new mammalian monoclonal antibody CMOs because it makes it easier, not only single use technology but also an increase in flexible manufacturing facilities. They go together, so we're seeing more and more of that kind of a CMO.
Gladd: Do you have any concerns about single use?
Alonso-Caplen: Of course. The concerns are especially in the leachables and extractibles, but the material that's mostly used for single use has been around for ages. Obviously, it does depend on the matrix of your materials, so part of our analysis is to make sure the matrix of whatever material we’re using in those single use systems is compatible.
Gladd: What do you think are the biggest areas for innovation in single use?
Alonso-Caplen: I'm actually waiting for a single use type of chromatography system. In particular, Protein A. It may even be available. I think, for affinity type of chromatography, you should be able to use membranes instead of resins. There are anion exchange filters available, and we've used them. They're cheaper, more efficient, and not much preparation goes into their use.
This November, Dr. Alonso-Caplen will be participating in a Qualifying CDMO Capabilities panel discussion at Outsourced Pharma West (OPW) in San Francisco, November 10-11. Along with other expert panelists, she will share lessons and advice on outsourcing. In addition, she will also deliver a presentation at the conference about Pfizer’s guiding principles for externalization (mentioned above).
We are thrilled to have her on the board, as well as a participant in OPW. Her expertise is sought by many, and we look forward to leveraging it in order to deliver the most relevant and useful information to our Bioprocess Online readers.
Welcome, Dr. Alonso-Caplen!