Jayna is responsible for the technical review, potential projects evaluation and proposal issuances at Baxter BioPharma Solutions Bloomington, Indiana site. Jayna has over 19 years of experience in the pharmaceutical industry. In this interview, Jayna provides her perspective on the key considerations when outsourcing an injectable project to a Contract Manufacturing Organization (CMO).
Why do contract manufacturers continue to play an important role in helping pharmaceutical and biotech companies bring their products to market?
Recent market reports tell us that the sterile injectable drugs market is set to grow in the coming years, driven by the increasing use of injectables in the treatment of cancer, diabetes, and cardiovascular diseases, among others. The COVID-19 pandemic has also contributed to this increasing demand and consequently, the market has seen a tightening of capacity.
For this reason, many pharma and biotech companies are having to outsource the manufacturing of their drug products. Yet, many have limited-to-no experience working with a CMO.
What are the key considerations for a company when determining if a vendor is right for them?
First, choose a provider with proven performance and expertise. The provider’s capabilities and experience should be backed by a strong track record, which gives insight into the number of their successful projects, their level of experience with different product types (antibodies, complex molecules, etc.) and their success with regulatory approvals (projects that have reached clinical phases, market approval, etc.).
Second, determine if a vendor can grow with you. Make sure to properly evaluate vendors and understand their expertise and how they can help you reach your goals as you evolve your outsourcing strategy. You might look at one service today, but you are likely to expand your scope in the future as your molecule matures or your pipeline expands.
Third, look beyond just unit cost to the full package of services the CMO can offer, including on-site regulatory support, analytical testing, stability services or excipient procurement. To evaluate total value, a service provider’s capabilities and track record should be well understood. Companies shouldn’t make a decision based on cost alone. They need to make sure that the service provider can successfully deliver on the project by meeting project milestones on time and on budget. Has the CMO completed similar projects in the past? Do they have the resources and expertise to successfully manage your project?
Fourth, ask for a facility tour to see the site and meet the team.
When is the right time to reach out to a CMO? What should a company already have in place?
Before reaching out to a CMO, I recommend a company have a few key pieces of information in place:
- Confidential disclosure agreement (CDA) – to protect their intellectual property
- API source identified
- Completed reports of any studies performed with other vendors (e.g., filter studies, analytical methods)
- A formal request for proposal (RFP) ready to be sent out to the CMO
What are the key elements of a successful RFP?
The more detailed the proposal, the more it can help with the decision-making process. I recommend that the RFP include:
- Pictures of items such as packaging components (labels, barcodes, dividers, cartons) and configurations, if available, are very helpful, as are drawings or outlined processes.
- If the client has assumptions, those are helpful and should be included as well, even if some items are not known with certainty.
- Important items that are needed up front include:
- Drawings of and part numbers for your selected container closure: This will determine if change parts are needed, which means longer lead times.
- Analytical needs: If known, include testing that the CMO is expected to perform and the instrumentation or method type that the CMO is expected to use, specifically, incoming ID method and finished product testing.
- Process flow diagram: This will immediately allow the technical team to evaluate your current or proposed process and then allow the CMO to see if it will directly correlate or if updates or changes are needed.
- MSDS: This will help confirm that the CMO site can produce your molecule based on their plant’s requirements.
- Preferred batch size (units) and number of batches per year.
- If lyophilized, the current lyo cycle time.
- Packaging needs: bulk, label then bulk, or full secondary packaging.
- Expected timeline, including timing for project award, validation batches and commercial start.
- Any product sensitives, API configuration, or time out of refrigeration (TOR) limits.
What are some common stumbling blocks when outsourcing a project?
One common stumbling block is defining project scope, meaning expectations should be clearly communicated to the service providers as early as possible. The project requirements will change over the progression of the project. To help overcome potential delays, have an open dialog with your service provider about any changes as soon as possible. The CMO will want to know your timeline so they can evaluate it against long-lead-time items, as well as confirm capacity availability on the line. Official scope will be solidified during the team kickoff meeting after the project has been awarded.
It's worth noting that many companies fail to anticipate long lead times for equipment and components. Few CMOs have equipment “off the shelf” and ready to go.
What should a company expect in a proposal from a CMO?
When reviewing proposals from various CMOs, it is very important for a company to ensure that it is “comparing apples to apples.” With that in mind, CMO proposals should include some critical information:
- Overview of what was requested in terms of batch size, number of batches expected per year, component selection confirmation, packaging plan and any other pertinent information.
- Any activities that the CMO would expect the client to cover during technical transfer (e.g., E&L and filter validation).
- Technical transfer costs: This will cover what is required to transfer and validate your product. These are typically one-time fees and will be executed throughout your entire tech transfer process.
- Equipment cost such as stopper bowls or tanks, if any.
- Batch pricing: Included for the customer to see what different types of batches will cost — for example, WFI fitment batch, development/engineering batch, PPQ batch, etc
- Clinical/commercial pricing: Should the RFP request this pricing after technical transfer activities, this would be included.
- This price will reflect specifically what is included in the cost. For example, if the customer or the CMO is procuring the container closure and if it is included in the final cost breakdown.
- Timeline: CMO should include the timeline that they can plan for and achieve. This may differ slightly from what was requested in the RFP upon plan evaluation.
What are some advantages of working with a CMO?
Companies can realize several advantages by working with a CMO to help bring their product to market.
First, experience: If a company is working with an established CMO, chances are high that the CMO has worked with a similar molecule before and can anticipate any hurdles.
Second, speed: CMOs have, by design, a “warm base” ready to go with trained staff and validated equipment. Working with a CMO can be much faster than building a capability in-house.
Third, flexibility: As CMOs operate multipurpose facilities and run products on shared lines, there is greater flexibility in terms of scheduling than some companies may experience when running their products in-house on dedicated lines. Large shifts in volume or timing are easier to accommodate when working across multiple products.