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7 Game-Changing Tips for a Successful Technology Transfer

By Tony D'Amore

Strategic Advisor | BrevisRefero

LinkedIn Profile

Many biotechnology companies, as well as large pharma companies, use biologic Contract Development and Manufacturing Organizations (CDMOs) to help support their product development and/or manufacture of clinical products.  This allows the sponsor company to focus on other priority projects such as advancing further research and early candidate development, as well as providing additional internal manufacturing or resource capacity.  There are many respectable CMDOs globally, however, finding the right CDMO partner may not be that simple or a fit within your planned project timeframe.  When searching for a CDMO, it’s important to understand the CDMO’s capabilities, technical track record, quality systems, cost structure, and capacity for new projects.  You also must consider that working with a CDMO requires developing a good working relationship to achieve positive outcomes, but equally important is creating a strong mitigation plan in the event of challenges.  Changing CDMOs during the product development phase inevitably impacts development timelines, as this requires both the selection of another CDMO and repeating technology transfer activities.  In some cases, a change in the CDMO partner may be necessary due to manufacturing constraints or scheduling conflicts, which is why it’s important to ensure that sufficient lead time is allotted in planning your outsourcing strategy.

There are many respectable CMDOs globally, however, finding the right CDMO partner may not be that simple or a fit within your planned project timeframe.

A key activity in outsourcing a biologics program is technology transfer, which can be a strategic competitive advantage and offer significant rewards for companies in terms of time, yield, and cost.  On the other hand, technology transfer can create program risks and can be the reason some companies shy away from transferring their manufacturing processes.  These risks include potential delays in timing and increased cost, a change in process or equipment, uncertainty on the impact on product quality attributes, capability of the facility, level of quality and regulatory assessment, lack of project management expertise, inability to support product development activities, and delays in eventual product manufacturing, to name a few.

Although there are risks, the benefit of technology transfer to a CDMO, or to other internal sites, far outweigh the risks if the technology transfer route is planned and managed well. Some helpful suggestions to ensure a successful technology transfer to keep product development timelines and cost on track are:

  1. Develop a Project Plan and Timeline.  For example, what product are you planning to produce and what processing technology is needed?  What competencies are required to meet the program objectives?  What is the timing, capacity, and volume required?  Performing an exploratory search for potential CDMOs that meet the project needs (RFP>Navigator®) inherently establishes a framework for a project plan and its timeline.

  2. Run a Comprehensive RFP Process.  Utilize a professional Request for Proposal (RFP) process to solicit proposals from an extensive list of relevant CDMOs, and then methodically pare down to a shortlist of 2-3 candidates for the project.  From there it’s important to perform due diligence activities by meeting the CDMOs that have been shortlisted - their staff, lab space, and manufacturing suites.  Evaluate their track record, quality system, and overall development strategy and then select the CDMO that best meets the needs of the project.

  3. Select the Right CDMO Partner.  Determine how long, and up to which clinical phase, the CDMO will be required and ensure the plan accounts for this. For example, does the program need early-stage clinical manufacturing only, or does it need a long-term commercial manufacturing partner?  Where possible, the number of technology transfers should be limited in moving the product through the value chain.

  4. Risk Mitigation Planning.  Developing a comprehensive risk mitigation assessment with the CDMO partner can help to identify and address program risks.  Such a plan allows all stakeholders to begin on the same page, ensuring the alignment of both the sending and receiving teams before the actual technology transfer activities begin.

  5. Be Hands On.  Take a hands-on approach and work with the selected CDMO in their facility to understand and transfer the process and supporting methods. As mentioned, creating a collaborative partnership further enhances overall program success.

  6. Invest the Resources.  By investing in the necessary resources to ensure efficiency and quality, the overall program objectives can be secured. If you don’t have your own Chemistry, Manufacturing and Controls (CMC) and quality unit, working with a third-party group can provide the necessary support and required expertise.

  7. Encourage Relationship.  Having a close working relationship with your CDMO could lead to decreased development time or a more productive process by leveraging each other’s resources and expertise, which can also lead to faster resolution if any problems occur during technology transfer.

To plan a technology transfer thoroughly and execute it carefully requires a significant investment of money, time, and patience

If any of these above points are not planned well, the program could suffer delayed timelines and increased cost for remediation, which could mean patients may not receive important treatment in a timely manner.  The net result of these risks is that some companies with their own manufacturing infrastructure may not even entertain technology transfer as an option to support their product development efforts. To plan a technology transfer thoroughly and execute it carefully requires a significant investment of money, time, and patience, however when well planned, it has far-reaching impact to project success, and can reduce overall program expenditures and timelines long-term.

In summary, product development speed is always an important factor in developing a new clinical target, however development speed is dependent on many factors.  For small biotech’s, it is important to ensure there is a well-established development plan to address the requirements for GMP manufacturing through a reputable CDMO to increase the likelihood of success of the program.

BrevisRefero’s professionals are biologics CMC development experts with collectively over 100+ years’ experience in technology transfer as discussed in this article.  Whether searching for your CDMO partner, planning your technology transfer, or managing your CMC program through a CDMO partner, BrevisRefero’s experienced team is your ideal partner for decreasing program risk, managing project timelines, and increasing successful delivery.

If you would like a free, no-obligation consultation to talk about your biologic drug development outsourcing, planning, budgeting, or execution then please reach out to us at: or call us at (905) 636 - 6559.

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By Tony D'Amore

Strategic Advisor | BrevisRefero

LinkedIn Profile


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