Joe Cobb, CPIP is manager of formulations at Lonza Capsugel.

Joe Cobb

Online documentation database; document management system DMS concept. FTP (File Transfer Protocol), Secure FTP. Internet cloud technology, exchange information and data storage concept. | Image Credit: ©Irene -stock.adobe.com

Technology transfer is a crucial component for sponsors and contract development and manufacturing organizations (CDMOs) alike when collaborating on the development and/or manufacture of pharmaceuticals. To ensure that a tech transfer follows good manufacturing practice guidelines and is successful, a risk assessment and gap analysis should be performed to identify missing data and characterize process parameters, according to Joe Cobb, CPIP, manager of formulations at Lonza Capsugel. Jamie Evans, manager of analytical method development and validation at Lonza Capsugel, describes how alignment with regulatory expectations can be achieved by analytical method transfer, pre-validation evaluations, and optimization.

Fostering productive sponsor-CDMO relationships is important, and this can be done through project managers, escalation policies, joint steering committees, and the coordination of regulatory and operations teams, according to Cobb and Evans. 

 spoke with Cobb and Evans to find out more about how tech transfer can be optimized.

PharmTech: How does a sponsor organization structure the technology transfer package when handing off a manufacturing process to a CDMO. What documents do you consider non-negotiable, and how do you ensure the receiving site can independently reproduce the process?

The CDMO and outsourcing market continues to grow at about 8-10% annually from 2024-2029 as pharmaceutical companies look for additional infrastructure and specialized manufacturing expertise. While outsourcing can help companies mitigate risk and accelerate timelines, technology transfer remains a critical phase that can introduce several challenges.

When working with new customers, the tech transfer package typically includes a bundle of critical documents and manufacturing records needed to advance the drug product into the next phase of development. We review the full package, including the supporting literature and data provided, and conduct an internal risk assessment. The risk assessment leads to a gap analysis that helps us identify any missing information in the customer’s technology package early in the project, as key details are often incomplete or unavailable at the outset.

Through this analysis, we identify the critical quality attributes and apply a quality-by-design (QbD) approach that supports regulatory readiness and development through commercialization. This creates a strong foundation for the project by establishing a quality target product profile that can guide the drug product as it progresses into later stages of development.

How does one handle gaps in process understanding discovered during transfer (e.g., a critical process parameter that wasn't adequately characterized at the sending site)?

Conducting a gap analysis is essential to uncover any missing details and can be managed through risk assessment, process control strategies, and strict change control management.

New technologies, such as compaction simulation, have been more recently introduced to mimic full-scale conditions and allow formulation scientists to explore feasibility earlier in the process. Compaction simulation is designed to evaluate formulations in small quantities to predict compression performance in both dry granulation by roller compaction or in tablet presses. This approach allows for minimal material consumption, guidance in excipient selection, and data-driven decisions for scale-up activities. This technology, combined with the appropriate control strategies, helps provide more accurate assessments to inform formulation and process selection in later stages of development.

Analytical method transfers are often a significant source of delay and failure in tech transfer programs. What is a good approach for qualifying analytical methods at a receiving contract laboratory. How do you define equivalence, and what do you do when method performance doesn't meet acceptance criteria at the new site?

Analytical method transfers require careful planning to ensure consistent performance across sites, which is why a structured method gap assessment is so important. We use that assessment to identify potential issues early, beginning with a detailed review of the method and any associated validation reports provided by the sending unit.

During this review, we look for differences between the sending and receiving sites, including instrumentation, materials, operating conditions, and laboratory practices. Identifying those differences up front allows us to define mitigation steps before they affect the transfer.

Before initiating the formal transfer, we also conduct pre-validation or pre-transfer evaluations of the method to confirm that performance at the receiving site aligns with what the client has reported. These evaluations help determine whether the method can meet the proposed acceptance criteria under receiving-site conditions.

If the method performs as expected, we can move forward with greater confidence. If it does not, we can recommend optimization before initiating the formal transfer protocol, reducing the likelihood of downstream delays or transfer failures.

Have you ever had a situation where the method itself needed to be revised during a transfer rather than just the site qualification? How did you manage that from a regulatory perspective?

At Lonza Capsugel, we evaluate whether a method is not only phase appropriate, but also suitable for quality control and long-term product lifecycle monitoring. In many cases, we receive a method, conduct a detailed assessment, and define an optimization plan before moving forward with transfer activities.

If the method does not yet meet the requirements for routine quality control, we pause transfer activities until it reaches an acceptable state. This helps ensure the method can support reliable monitoring across the lifecycle of the program. From a regulatory perspective, our approach is aligned with FDA expectations and global International Council for Harmonisation (ICH) guidance, which are reflected in our internal procedures. Our regulatory team also actively monitors updates to guidance, so our processes remain current.

How can sponsor companies maintain meaningful technical oversight without creating an adversarial dynamic or micromanaging the CMO's operations? What governance mechanisms, such as joint review boards, data sharing cadences, or escalation paths, work well?

Successful technology transfer depends on treating the sponsor-CDMO relationship as a true partnership rather than a transactional service. From the start of a partnership with a drug sponsor, we establish processes that move the relationship beyond a transactional service model and toward true collaboration. This helps create open communication channels, shared understanding and clear expectations as the drug product progresses through development.

 To support that collaboration and governance structure, our project managers serve as the primary point of contact for customers, ensuring information flows through a clear and consistent channel. We also maintain an escalation policy that iscloselyconnected to our project management structure.In addition, a joint steering committee brings together members of our site leadership team and the sponsor’s team to support alignment, decision-making, and issue resolution throughout the project.

Technology transfer to a new contract site often triggers regulatory submissions (e.g., site changes, comparability protocols, or new marketing authorization applications). How do you align your transfer execution timeline with regulatory strategy to avoid commercial supply gaps? How do you coordinate between your chemistry, manufacturing, and controls (CMC) regulatory team and the operations team at the contract organization?

Avoiding regulatory delays begins long before a submission is prepared. Aligning technology transfer with regulatory strategy starts with a QbD mindset. From the outset, we focus on risk assessment and the quality target product profile because those elements define what matters most to product performance, patient safety, and regulatory readiness.

We establish that foundation by reviewing the available reports and data within the technology transfer package or by conducting a gap assessment when key information is missing. This helps identify the critical components needed to support a robust QbD framework and ensures the transfer strategy is aligned with ICH guidelines and future regulatory submissions.

Strong coordination between CMC regulatory and operations teams is also essential. Internally, it ensures that technical decisions are made with regulatory commitments in mind. Externally, clear communication with the sponsor helps align on clinical milestones, submission timelines, supply needs, and the overall transfer objective.

At Lonza Capsugel, our regulatory team is integrated into the process, so all details are captured early, and the execution plan supports both technical transfer and regulatory strategy. Ultimately, avoiding gaps in regulatory submissions and commercial supply depends on strong communication between sponsors and CDMOs where there is a common understanding of the goals, timing, risks, and decision points before transfer execution begins.

Jamie Evans is a manager of analytical method development and validation at Lonza Capsugel. He brings more than 20 years of experience in the pharmaceutical industry, including more than 15 years in the CDMO space, with expertise in analytical validation for oral solid dosage forms and inhalation products. In his role, he supports customers throughout the tech transfer process at every stage of the product lifecycle.

Joe Cobb, CPIP, is a manager of formulations at Lonza Capsugel. He brings more than 30 years of experience in the pharmaceutical industry, including more than 25 years in the CDMO space. His expertise is in drug product design and development. At Lonza Capsugel, he specializes in formulation development, helping customers scaleup and navigate tech transfer at any stage of the product lifecycle.

Articles

Successful sponsor–CDMO technology transfer hinges on early risk assessment and gap analysis to surface missing data, define CQAs/CPPs, and implement QbD control strategies anchored by a quality target product profile. Process-knowledge gaps can be managed with change control and tools such as compaction simulation to predict compression performance using limited material. Analytical method transfer benefits from structured method gap assessments, pre-transfer evaluations, and optimization before formal protocols. Governance via project managers, escalation paths, and joint steering committees aligns CMC regulatory and operations plans to prevent submission delays and supply gaps.

PharmTech spoke with Jamie Evans, manager of analytical method development and validation, and Joe Cobb, CPIP, manager of formulations, both with Lonza Capsugel, about best practices for pharmaceutical technology transfer.