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Capacity concerns and regulatory compliance considerations will drive the decision about outsourcing the manufacture of clinical trial materials.
The increasing trend in outsourcing manufacturing also applies to clinical trial materials, and having the right strategy to manufacture clinical trial materials is crucial for moving product forward in the development pipeline. While some drug developers may have capacity and capability to manufacture in-house, other developers have need to outsource to an experienced partner. What are the key advantages of having a contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO) partner at the clinical trial stage of drug development and what are the primary challenges of in-house versus outsourced manufacturing? BioPharm International spoke to Justin Carbungco, lead engineer at Samsung Biologics, for some insight.
BioPharm: What is the primary advantage(s) in outsourcing manufacturing of clinical trial materials to a CMO/CDMO?
Carbungco (Samsung Biologics): There are two primary advantages when outsourcing manufacturing of clinical trial materials to a CMO/CDMO. The first advantage is monetary savings due to not having to build and fully validate a manufacturing space. The second is time savings, as you can immediately start moving forward on tech transfer to manufacturing.
Building and maintaining a manufacturing space is very resource intensive, and you would lose time in order to get the facility up and running, which in turn would slow down the timeline for manufacturing the materials.
BioPharm: What challenges are present in manufacturing clinical trial materials in-house vs. with a CMO/CDMO? On the other side of that, what challenges are present for a drug developer in working with a partner for clinical trial materials?
Carbungco (Samsung Biologics): Manufacturing clinical materials in-house does pose some challenges, such as the cost of maintaining the internal facility. This cost has to be justified, which may mean some smaller companies may not have the capital for it or a large enough product pipeline to make full use of the investment. Working with a CMO/CDMO proposes its own challenges as well, such as choosing a partner that has the right facility fit to accommodate your product and has the reliability to manufacture the material right the first time and within your desired timeline. Both options have their pros and cons, and will be very dependent on the company’s financial and development situation.
BioPharm: What logistical and technical considerations must be taken into account when outsourcing manufacturing specifically for clinical trial applications?
Carbungco (Samsung Biologics): Communication and timeliness are the key considerations when dealing with an outsourced manufacturer for clinical trial applications. Both the client and the manufacturer have to have clear and reliable communication with each other to make sure that timelines are met and that events are handled in a proactive and timely manner. Unreliable communication can result in possible delays or issues that could severely impact the client’s product timelines.
BioPharm: What are some best practices tips for CMOs/CDMOs looking to be clinical trial manufacturing partners?
Carbungco (Samsung Biologics): Flexibility is the important key when it comes to clinical trial manufacturing.This doesn’t mean ignoring good manufacturing practice (GMP) requirements, as you are still making materials for human use. What it means is having flexibility in two main aspects: scale and your tech transfer/manufacturing process. Flexibility in scale allows CMOs/CDMOs to accommodate the different needs of the client depending on the clinical phase they are in.Early phase materials (Phase I/II) do not need as much material (typically less than 500 L capacity) because the sample size in the clinical trials is smaller. Late phase (Phase III) will need much more (1000 L or more) because the sample size will have increased by that point.
Flexibility in the tech transfer and manufacturing means that the CMO’s or CDMO’s process can apply the correct level of GMPs based on phase appropriateness. This is because the early phase materials process is still being worked out and may require adjustments that may not have been apparent in the laboratory development stage. Late-phase processes are more established because the work was done in the early phases and the late-phase stage leans more into proving that the process works with very minimal adjustments.
BioPharm: What are some of the key regulatory concerns that a CMO/CDMO must address when manufacturing clinical trial materials for a client?
Carbungco (Samsung Biologics): Maintaining proper GMPs as it relates to clinical manufacturing and how it applies to phase-appropriate manufacturing is a key concern. Regulatory agencies provide guidance documents on how these items work off each other, and it is in the CMO’s or CDMO’s best interest to make sure that their procedures and processes fit within these requirements to avoid unnecessary work and still maintain proper compliance with regulatory requirements.
Feliza Mirasol is the science editor for BioPharm International.