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Selecting the right CDMO

Titelbild Selecting the right CDMO. Frau sitzend auf einem Stuhl

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A strategic manufacturing partner can be a vital asset for a drug developer who’s ready to shift from preclinical to clinical development. Andrea Wesp, VP New Business Development at Vetter, explains how and when to build a new partnership with a specialized aseptic filling CDMO.

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Featured expert

Andrea Wesp, VP New Business Development

Andrea has more than two decades of experience with outsourced supply and manufacturing services for the life sciences industry. At Vetter, she plays a key role in building new CDMO partnerships with pharma and biotech companies of every size.

Key insights in this video

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What a strategic CDMO should contribute to your drug development program

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What to look for in a potential aseptic fill and finish partner, and how to evaluate their skills and expertise

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How to plan an efficient, effective RFP process that aligns your needs with your partner’s capabilities

Preparing for a key strategic partnership

For companies developing a new injectable drug product, sourcing aseptic fill and finish services is a key step in the transition from lab to clinic. To launch in-human trials of a new parenteral therapy, the developer must know—and show regulators—that their product is being filled to the highest possible quality standards. A professional CDMO is essential to achieving that goal.

Selecting that manufacturing partner is often one of the first critical outsourcing decisions that early-stage drug developers need to make on their path to the clinic. It’s also a process that smart drug developers start early, giving themselves time to identify strong candidates, perform thorough due diligence, and ensure alignment between their goals and the CDMO’s capabilities.

What should you look for in a CDMO who’ll effectively support your success? That partner should not only have deep expertise in aseptic fill and finish, but also a deep understanding of your molecule and development goals. To determine if they offer that mix of skill, knowedge, and experience, focus on the questions they ask. A smart, strategic CDMO will want to know:

  • Key properties of your drug substance: For example, its potency and toxicity, how it will be packaged when it arrives at their aseptic filling facility, sensitivities and stability limits, and any other characteristics that will determine how your drug substance will need to be handled and protected.
  • Your API’s packaging configuration: How it will be packed and shipped from your facilities to theirs.
  • Roles and responsibilities: Who’ll be expected to manage and direct key dimensions of the project like analytical methods and batch release processes.
  • To better understand the CDMO’s capabilities, take the time to ask key questions of your own too. Make sure you carefully evaluate:
  • Their supply chain: Do they already have ready access to the raw materials and excipients they’ll need to scale production of your API, then package it once it’s filled? Or do they need to source and qualify new suppliers for your project?
  • Schedules and timelines: Do they have the time and resources to support your molecule and fill it when you need it?
  • Resources and availability: Do they have the right filling line capacity at the right time when you need to fill your clinical batches?


The more thoroughly you explore these topics with your CDMO, the clearer you’ll both be on whether your new partnership will deliver the success you need to advance your clinical program.

Planning a successful, efficient RFP process

To launch the search for a new CDMO, most drug developers start with an RFP (request for proposal) process. This approach allows you to formally assess whether the capabilities of the CDMO align with your molecule and goals, and also gives potential partners the opportunity to determine if their skills and resources are a good match for your fill and finish project.

RFPs can be complex and time-intensive, so focus on three critical areas to help ensure that your CDMO search runs as efficiently as possible for both you and your potential partners:

  1. API considerations: CDMOs will need a range of key information on how to handle your API during the transfer to their facility. Be ready to share information about packaging, excipients, sensitivities, stability, potency and toxicity, and any other relevant details that will tell your CDMO how they’ll need to protect your drug substance—and the people who’ll handle it.
  2. Technical parameters: To ensure your project delivers the supplies you need for your trial, CDMOs need to accurately define the resources and processes required to meet your needs. Be prepared to discuss your container closure system, target batch size, analytical methods, and how your product needs to be stored after filling.
  3. Project schedules: Experienced CDMOs will want to know that they’ll have the right resources and facilities available when you award them a new project. To help them achieve that critical goal, be clear and upfront about when you plan to initiate your project, your target fill date, and when you need your clinical supplies to be released to your sites.


Needless to say, it’s important to allow sufficient time for this detailed, multidimensional process—so start early! The optimal time to launch your CDMO search is typically around the time you’re finalizing your formulation and analytical methods, and making a decision on your NDA or CTA date. Take the time to find the right CDMO, and they can have a significant impact on not just those key early milestones, but also the long-term success of your molecule and company.

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