The role of contract development and manufacturing organizations (CDMOs) serving the pharmaceutical industry used to be reasonably straightforward—cost-effective services and efficient capacity for the manufacture of well-established active pharmaceutical ingredients (APIs or drug substance) and drug products. While crafting a request for proposal (RFP) to capture the information innovators need to select a CDMO partner has always been critical; it has grown increasingly complicated.
Today, CDMOs fulfill more diverse needs than ever, from traditional capacity and manufacturing efficiency to turnkey solutions for partially or entirely virtual development organizations. CDMOs can also be highly specialized providers of technologies and expertise for novel advanced therapeutics.
Given the increasingly diverse therapeutics, processes, and go-to-market strategies innovators require from CDMOs, a comprehensive RFP is more critical than ever.
The Role of a Well-Crafted RFP
Ultimately, an effectively designed RFP will result in selecting a biologics CDMO that can manufacture your product at the needed scale and in your required timeline. Additionally, the CDMO will need to understand phase-appropriate guidances, have a flexible and skilled project team, offer appropriate program support, operate utilizing a robust cGMP-compliant quality management system, and have the advanced technologies required to help you mitigate risks and speed up time to market.
Providing a well-thought-out RFP will help potential partners understand your needs and objectives going into the proposal process and make your biologics CDMO selection process more effective.
Needs & Gap Analyses: The Cornerstones of the RFP Creation Process
Assembling a multidisciplinary team of executive management, scientific staff, and clinical and financial team members to conduct thorough needs and gap analyses will create a strong foundation for your RFP. These analyses will assess the capabilities and capacity you need to produce your product, and outline the level of expertise your organization requires in a biologics CDMO partner.
Some key questions to consider when conducting your needs and gap analyses include:
- What are our timeline and capacity requirements?
- What is our budget for this program, and are their milestones directly tied to our funding/organization’s financial health?
- How much biologics process development assistance do we require?
- What are the gaps in our organization’s drug and biologics process development expertise?
- Are we lacking understanding of our therapeutic’s critical quality attributes?
- Where are the gaps in our current analytical and CMC packages?
- Which novel technologies are needed to develop our therapeutic?
- What are the known risks in our biologics development program?
- Are we seeking an integrated CDMO partner to serve our needs throughout our product’s lifecycle?
- Do we require regulatory and filing support?
In many cases, development teams are unaware of some program needs or gaps that may put their program and timelines at risk. However, an experienced CMDO will be able to spot gaps or needs that weren’t identified initially and make recommendations accordingly.
Designing a Biologics CDMO Services RFP
As an essential resource for your team and potential partners, the finished RFP must provide the information needed to make recommendations and ultimately craft an effective proposal. Conversely, the RFP must request the information your organization needs to make the best partner selection decision.
Your RFP should include the following:
Overview
Provide an overview of your program and organization, including a brief company history. Additionally, describe all relevant background information for the therapeutic, including the phase of development, targeted disease state, patient population, the problems your therapeutic can address, and an overview of the therapeutic’s key characteristics.
Additionally, this overview should convey specialized requirements, like the use of novel methods or capabilities, such as the ability to manufacture controlled or high-potency substances, and regulatory filing assistance needed.
This section should also provide an overview of the program’s timeline and any pertinent funding-related information. For example, if your funding is tied to specific milestones, this information could significantly impact how a biologics CDMO partner approaches the program.
RFP Timeline and Selection Criteria
In this section, share your timeline from the RFP launch, questions, and discussion period to partner selection. Also, describe the process for fielding additional questions or holding further discussions. Finally, provide an overview of the criteria you will use to select your biologics CDMO partner.
Scope of Work
Leaning heavily on the information gathered within your needs and gap analyses, this section provides more technical product and program requirements/expectations. While this list is not intended to be comprehensive, it offers an excellent starting point.
- Further drug product detail—dose, dosage form, scale, drug delivery mechanisms, etc.
- Information available to transfer to the CDMO, such as manufacturing process details, analytical test method procedures, reference standards, etc.
- Previous manufacturing history
- Current process flow
- Any known key processing parameters
- Known gaps in product or process understanding
- Known product or process risks
- Specific known deliverables/expertise needed, such as process, formulation, and/or analytical method development, stability study execution, etc.
- Release and stability testing requirements with specifications, as available
- Needed program management support
Program and Regulatory Filing Timelines
In this section, you will share your phases of development timeline, including any key milestones. If any aspect of your program’s funding or your company’s financial viability is tied to specific milestones, detail the information within the RFP to assure that your organization and your selected CDMO are working in tandem.
Laying the Foundation for a Highly Successful Partnership
As a biologics CDMO serving many emerging biotherapeutic organizations, Scorpius BioManufacturing has a unique perspective on the RFP and partner selection process.
The extensive experience among our executive management, scientific, and operational teams allows us to fill the technical gaps within many of our partners’ organizations. However, it helps to include as much information within the RFP as possible, as a well-constructed RFP saves time for both the innovator and potential biologics CDMO partner and increases the accuracy of the proposed deliverables and costs.