What CDMOs Wish Biotechs Knew Before Submitting An RFP

By Tamika Drummond, Ph.D., external MSAT manager, AbCellera

My first experience leading a request for proposal (RFP) submission to a contract development and manufacturing organization (CDMO) was a lesson in what not to do. I had a general understanding of the project goals but lacked a clear, detailed scope of work. Without a well-defined project outline, supporting data, or internal alignment across departments, the RFP fell flat. What followed was a flurry of clarification emails, missed timelines, and frustration on both sides. It became evident that a poorly constructed RFP not only hampers the selection of the right CDMO partner but can delay the overall program significantly.

Since then, I’ve worked with multiple CDMOs across different programs and therapeutic modalities. Each experience reinforced the same lesson: a strong RFP can make or break a partnership. CDMOs operate in a competitive, capacity-constrained environment. They need enough information to make a confident bid, allocate resources, and determine strategic fit. Biotechs, in turn, benefit from faster turnaround times, more accurate quotes, and fewer misunderstandings when they submit high-quality RFPs.

This article offers a practical guide for biotech companies preparing RFPs, informed by real-world experience and feedback from CDMOs.

The RFP As A Strategic Tool

An RFP is not merely a formal request for pricing. It is a reflection of a company’s preparedness, professionalism, and strategic clarity. CDMOs often use the RFP to gauge not only the technical requirements but also the likelihood of a smooth collaboration. If the RFP is vague or incomplete, they may deprioritize it in favor of opportunities with greater transparency and alignment.

Developing an RFP should be a collaborative effort. The best RFPs are shaped by input from:

• Leadership: Set strategic objectives and prioritize timelines.
• Technical/Scientific Teams: Provide detailed descriptions of the molecule, process, and testing requirements.
• Regulatory Affairs: Ensure that compliance standards and regulatory filing needs are communicated.
• Supply Chain and Commercial Teams: Project demand, commercial intent, and long-term scalability.
• Legal and Finance: Outline contractual terms, budget expectations, and funding timelines.

Cross-functional engagement ensures that the RFP is not only technically sound but aligned with business goals and regulatory requirements.

Key Elements Of A Strong RFP

1. Detailed Scope of Work

This is the cornerstone of a successful RFP. The scope of work should describe, in clear terms, the services being requested. For example, if you are seeking drug substance manufacturing, the RFP should include details about the expression system, upstream/downstream processes, expected yields, and any prior development history. For drug product manufacturing, the RFP should outline dosage form, fill volumes, container closure systems, and formulation challenges.

Tip: Include a visual process map if available. Even a basic flowchart can help CDMOs quickly understand your current process stage and needs.

An ambiguous scope leads to misinterpretation, inconsistent proposals, and inefficiencies during execution. A well-articulated scope aligns expectations and allows CDMOs to assign the right subject matter experts to the proposal.

2. Project Timelines and Milestones

Include a realistic project timeline with clearly defined milestones. CDMOs need to understand not only your ideal start date but also critical deadlines for material availability, regulatory submissions, or clinical trial initiation.

Be transparent about whether your timeline is flexible or fixed. If submission of an IND or initiation of a clinical trial hinges on this work, highlight those dependencies early. CDMOs can then assess feasibility and identify any scheduling conflicts in advance.

3. Forecasting and Demand Planning

Even early-stage biotechs should attempt to provide demand forecasts. How many batches are needed for the initial phase? What is the expected scale-up plan? What volume will be needed for toxicology studies, Phase 1, or future commercial campaigns?

These forecasts help CDMOs assess whether they have sufficient capacity and allow them to plan their resource allocation accordingly.

Don’t let uncertainty prevent you from sharing projections. CDMOs value transparency over false precision.

Even rough projections can be helpful, especially if accompanied by assumptions and confidence levels.

4. Technical Data and Development History

Provide relevant technical data, including formulation details, analytical methods, prior stability studies, and batch history. This information helps CDMOs evaluate technical feasibility and avoid redundant development.

Be honest about gaps in data. CDMOs can help bridge those gaps, but only if they know about them up front. The more context you provide, the better tailored and accurate their proposals will be.

Examples include: formulation composition, stability summary tables, process descriptions, and critical quality attributes.

5. Regulatory and Quality Requirements

Clarify the regulatory pathway and compliance expectations. Will this product be filed in the U.S., Europe, or other markets? Will the materials be used in GLP or GMP settings? Are there specific requirements for documentation, data integrity, or QMS alignment?

Communicating regulatory intent early ensures the CDMO can prepare the right infrastructure, documentation, and quality oversight.

6. Evaluation and Decision Criteria

Spell out how proposals will be evaluated. Will cost be the primary driver, or are experience, responsiveness, and location equally important? How will you weigh technical capabilities vs. timeline flexibility?

When CDMOs understand how decisions are made, they can tailor their responses more effectively and provide relevant supporting materials.

The Risks Of A Poorly Written RFP

When an RFP is vague, incomplete, or lacks internal alignment, the downstream effects can be significant:

• Prolonged Vendor Selection: CDMOs may request multiple rounds of clarification, delaying selection.
• Inaccurate Proposals: Without detailed inputs, CDMOs may base their estimates on assumptions that later prove incorrect, requiring rework and renegotiation.
• Loss of Preferred Vendors: Top-tier CDMOs often operate at full capacity. If your RFP appears disorganized, they may deprioritize it in favor of better-defined projects.
• Delayed Project Execution: Time lost during the RFP phase can cascade into timeline slippage, affecting downstream milestones like IND submission or trial initiation.
• Higher Costs: Misaligned expectations and scope creep during execution often lead to change orders, increased fees, or project inefficiencies.

Best Practices To Streamline The RFP Process

• Start Early: Don’t wait until timelines are critical. Early engagement allows time for clarifications and alignment.
• Use NDAs Proactively: Get confidentiality agreements signed early so technical data can be shared freely.
• Host a Kickoff Call: Allow vendors to ask clarifying questions after reviewing the RFP. This reduces misinterpretations.
• Give Feedback: Whether a CDMO is selected or not, feedback helps vendors improve and fosters goodwill for future opportunities.

An RFP is more than a transactional request. It’s a strategic document that can set the tone for your external partnerships. A well-crafted RFP with a clearly defined scope of work, thoughtful planning, and cross-functional input signals to CDMOs that your team is organized, collaborative, and ready to engage.

The more time and thought invested up front, the fewer surprises and setbacks will occur downstream. In today’s competitive and capacity-constrained CDMO landscape, that preparation can be the difference between success and delay.

About The Author:

Tamika Drummond, Ph.D., is the external MSAT manager at AbCellera. She is a biopharmaceutical professional based in Canada, with a background in manufacturing sciences and external collaboration strategy. With hands-on experience in CDMO selection, technical oversight, and cross-functional program leadership, she brings a practical perspective to drug development and outsourcing.

Disclaimer: The views expressed in this article are solely those of the author and do not represent the views of her employer.