FUJIFILM Irvine Scientific sat down with Sheng Li, PhD, Program Manager, to speak about our rapid service for small-scale media production. Read the full Q&A below as he provides an in-depth discussion about how Express Media Service can benefit you.
Q: What does Express Media mean and what makes it express?
A: Express Media Service (EMS) refers to our service program manufacturing and delivering small-scale, prototype, Research Use Only (RUO) cell culture media within 10 days after the order is received. Our 10-day turnaround time is among the fastest in the industry.
Q: Are the media made in Express Media Service (EMS) similar to the GMP media that FUJIFILM Irvine Scientific provides?
A: Yes. The EMS laboratory uses similar equipment, processes, and raw materials as those that are used in our GMP facility. This helps guarantee a smooth transition and transfer of process when a customer’s media are ready for GMP manufacturing. However, to meet customers’ demands in this highly competitive and fast-moving field, EMS manufacturing processes are not subject to the same guidelines as GMP, and all EMS products are RUO. Express Media Service is often the first place to provide assistance for customers’ needs in early development stage, and to manufacture their prototypes in the fastest way possible.
One important benefit of starting with EMS is that we can assess the formula’s GMP manufacturability, and will recommend test lots or scale-up testing as needed. This can help identify potential problems at early stages to assure a smooth transition to GMP when customers are ready.
Q: How do customers use EMS service?
A: EMS media are for Research Use Only and not intended for use in patients. The service is ideally suited for scale-down modeling, small-scale process development prior to scale-up, and media screening for custom products, and thus EMS is the ideal first stop for customers on the pathway to commercialization. For EMS, we limit batch size to 18 kg for powder and 200 L for liquid. The smaller size of EMS lots is beneficial because customers can experiment with new formulas before selecting one for their manufacturing application. In addition, our feasibility scientists assess whether media can be made in GMP, as part of the tech transfer process.
Q: Are there quality tests and a certification statement for EMS media?
A: Yes. We provide a Certification Statement for all EMS products, which includes the Lot number, Appearance, pH, and Osmolality values.
Q: If I think there is a problem with a formula I want made in EMS, can I get support from FUJIFILM Irvine Scientific?
A: Yes. For starters, our Formulation and Feasibility Scientists may suggest different forms or concentrations of media components to replace those they consider problematic in some way, for example with regard to solubility. Customers can also partner with our newly established Manufacturing Science and Technology (MSAT) group to address issues with hydration or other handling of media powders. MSAT provides an additional resource for solving problems with solubility and preparation procedures, as our scientists can also contribute to improving the formula and streamlining the media preparation process.
Q: How long does it take to receive a new formula for EMS?
A: We target a 10-day turnaround once the customer PO is in-house. However, a new formula may elicit some questions from the Feasibility team, requiring that we reach out to the customer, and that can lengthen the process. While raw material availability can be an issue leading to longer lead times, our well-established network of suppliers and the unique sourcing capabilities of the EMS program always endeavor to keep delays to a minimum.
Q: Can I order EMS media repeatedly if I am not ready to scale-up to GMP?
A: Yes, a customer may order EMS media repeatedly. There is a batch size limit of 18 kg for powder and 200 L for liquid, and while a larger batch cannot be made, several batches to fulfill a larger volume requirement for EMS can be manufactured. Situations like this happen when a customer is testing different aspects of the media and isn’t ready to scale-up to GMP yet.
Q: Will you let me know if my media doesn’t appear to be manufacturable?
A: Yes, absolutely. That is our responsibility. If we identify any potential problems, or if we see a need to run a test lot, we will reach out to the customer. FUJIFILM Irvine Scientific offers several different options to resolve media issues in collaboration with customers. Internal process development teams such as Manufacturing Science and Technology (MSAT) and Manufacturing and Engineering (MSE) are here to help.
About Sheng Li, PhD
Dr. Sheng Li joined FUJIFILM Irvine Scientific in 2017 as Program Manager to lead the newly established Manufacturing Support and Services group that includes Express Media Service (EMS). He has over 20 years of industry experience in R&D, new product development, and has profound experience in leading the most complex programs involving inter-departmental and cross-functional teams.