Tech Transfers in Pharma: Definitions and Key Processes in Technology Transfers

Pharma and biotech companies are increasingly outsourcing production to reliable contract development and manufacturing organisations (CDMOs). Tech Transfers are critical factor in these partnerships to be successful in developing, manufacturing and managing risk associated with moving manufacturing between sites. To learn more about Technology Transfers and their role in biopharma outsourcing, make sure to take the Outsourcing Fundamentals e-learning course

What is a technology transfer?

In the pharmaceutical industry a technology transfer -more commonly known as a tech transfer – is a series of knowledge transfers on a drug product and its established manufacturing processes from development to commercial production. The ICH Q10 guidance explains the purpose of technology transfer as follows:

The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realisation. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.

Source: Atos It can also mean knowledge transfer about existing products from one manufacturing site to another by a facility change, a company merger, an acquisition, or a shift to a contract manufacturer (CMO). To successfully scale drug development and manufacturing, tech transfer is essential. But it’s also costly, complicated, and time-consuming. Completing a pharma tech transfer requires more than $5 million, a team of experts, and can take from 18 to 30 months. As can be seen in this research from McKinsey, transferring externally increases lead time by 5.8 months, compared to an internal transfer. This timeline shows the steps involving before during and after a tech transfer:

Expertise required in tech transfer

Technology transfer requires a diverse set of expertise. Here are some of the key areas:

• • Knowledge transfer

• • Experience sharing

• • Communications

• • Inter and intra-company cooperation on a large scale.

EXPERT ADVICE Tech Transfer Mastery: Key Insights from CDMO Live A revealing roundtable at CDMO Live 2025 exposed that approximately 50% of tech transfers experience quality problems, highlighting why effective technology transfer has become a critical differentiator in the CDMO market. Four critical focus areas emerged:

• Proactive communication and transparency
• Robust documentation and knowledge management
• Clear alignment of expectations and deliverables
• Process robustness

The “contract-to-execution gap” was identified as a major challenge, where companies experience an “agility-break” between signing business and starting work, often requiring a second knowledge transfer. Essential takeaways 1. Build robust documentation systems from the outset 2. Maintain team continuity from sales through implementation 3. Implement comprehensive risk assessments covering quality, business, and EHS dimensions 4. Focus on cross-functional project management with clear governance structures The discussion emphasised that mastering tech transfer represents not just operational necessity but a strategic opportunity for competitive advantage. Download the full CDMO Live report here

How to manage a Tech Transfer

The success of technology transfer hinges on several elements, notably the foresight to identify potential risks and the strategic planning to address them. This ensures the team’s readiness to handle all scenarios, including unexpected occurrences. It’s essential to integrate various facets of launch readiness – such as machinery, manpower, materials, manufacturability, measurement, market, and risk mitigation – through a thorough risk management process. There are typically 3 main stages of a tech transfer. These are as follows: Stage 1: Defining and scoping

• • Gathering knowledge to scope and establish the project’s organisation and charter

• • Outlining program status and future outcomes

• • Conducting gap analysis and failure modes as well as effect analysis risk assessment. This should include:

– Project stage: Pre-clinical/ Clinical/Commercial – Current vs. Required scale to meet forecast – Specifications – Scale-up methods and procedures – Critical Process Parameters – Critical Quality Attributes – Capacity Alignment

• • Identifying and covering long lead time items

• • Defining the transfer protocol

Stage 2: Planning

• • Developing a work breakdown structure and preliminary schedule

• • Refining transfer protocols by respective parties

• • Outlining critical milestones

• • Gathering resource estimates

• • Determining the most suitable course of transfer based on the outcome of risk assessment

• • Assessing the robustness of scaling processes

• • Developing risk management plans

Stage 3: Execution

• • Tracking and managing the project by program team

• • Collecting status data

• • Analysing variances in operational data

• • Identifying adaptive actions to assure quality and process optimization goals

• • Reporting on project status to ensure transparency

Standardised Tech Transfer Procedures

Contract manufacturers have to be very flexible to accommodate various client needs, a standardised tech transfer procedure and common language are established to enhance the tech transfer process. Technology Transfer Package (TTP)is the key document or set of documents that are the basis for the activity of technology transfer. TTPs are a means of communicating process information and knowledge to their recipients – the vendors that the sponsors select to perform the work. 1.Knowledge Transfer Package and Transfer Planning The client should provide as detailed and complete knowledge transfer package as possible with product information 2. Detailed Assessment of the Product Technical Package A detailed assessment of the technical package must be completed to understand the scale and equipment differences in the planning stage. 3. Analytical Method Transfers in the Early Stages of a Tech Transfer Analytical methods are needed in the preliminary stages of a tech transfer as all the studies require certain testing to provide data and demonstrate the study results. 4. Regulatory Submission Preparation Checklists are a great tool in helping to prepare regulatory submission packages by Regulatory Affairs and the functional teams. 5. Product Launch Preparation The contract manufacturer should have a defined process for product launch so the team is ready for commercial supply to support the product launch.

How to accelerate the tech transfer?

Tech transfers in a highly regulated industry such as pharma can be a slow process. Here are strategies for how to accelerate time needed for a technology transfer while maintaining necessary quality.

• • Digital Twin Strategy: A digital twin, a digital replica of the design space, allows companies to run a comprehensive set of virtual experiments. This enables a focused set of physical experiments to be chosen that efficiently utilise time and materials to fine-tune the design for optimum yield and quality assurance.

• • Quality by Design (QbD) Framework: Following the QbD framework ensures that deep and detailed product and process knowledge is generated, evaluated, and documented throughout the whole product lifecycle.

• • Dedicated Project Management Team: Establish a dedicated project management multidisciplinary team. This team will manage effectively and timely all communications between stakeholders.

• • Standard Operating Procedures and Documents: Templated standard operating procedures and documents, approved by the quality team, will increase the speed, efficiency, effectiveness, and quality of technical transfer.

• • Comprehensive Protocols: A comprehensive protocol coupled with carefully designed technical transfer protocols can enable a smooth technology transfer of your process.

Complexities of technology transfer

Common challenges for tech transfers include:

• • Scope of Transfer: The complexity of technology transfer is determined by how much of a production chain is transferred. This could range from a single element (e.g., drug product fill and finish) to an entire process (from cell-bank manufacture to final drug product, with all the associated testing). The scope of transfer is a management decision with operational and strategic elements.

• • Size of Transfer: The larger the scope, the more complex the transfer becomes. Complexity increases even more if different sections (e.g., drug substance, drug product, and analytics) are transferred from or to different sites.

• • Multidisciplinary Activity: Technology transfer is a multidisciplinary activity involving diverse skills and competencies of participants, including project management, quality assurance/control (QA/QC), technical capabilities, engineering, manufacturing, and validation.

• • Structural Reasons: In the biopharmaceutical industry, technology transfer is common for a number of structural reasons. These include the dichotomy between small, innovation-based drug companies and large ones able to conduct late-phase clinical development and endowed with manufacturing capacity; the high capital cost of biopharmaceutical plants, which makes contract manufacturing attractive; and the need for multiple scale-ups during a product’s life cycle.

Considerations when choosing a contract manufacturing partner

When seeking technology transfer support from a Contract Development and Manufacturing Organization (CDMO), it’s crucial to verify the CDMO’s track record and the strength of its project management and technical infrastructure. This validation is key to ensuring the CDMO’s capability to comprehend and meet project specifications, manage potential risks, and deliver the project promptly and accurately on the first attempt. Here are some areas to consider when planning to transfer to a contract manufacturer: 1. Geographic footprint Gaining a comprehensive understanding of the market landscape goes beyond simply securing global manufacturing capacity as that is merely a tactical aspect. Your manufacturing partner should fully comprehend your campaign’s terrain and the broader landscape of your drug marketing strategy 2. Technology The relevant technology surpasses the latest spray dryer or bioreactor. Your partner’s capabilities limit the potential of the equipment used. It is important to review your partner’s tech transfer performance against their ability to:

• • Recognise and leverage economies of scale while prioritising safety and sustainability

• • Deliver processing capabilities that are robust, reliable and validated, ensuring consistent and high-quality outcomes

3. Regulatory compliance Evaluating a CDMO partner’s potential requires a thorough understanding of their ability to proactively maintain regulatory compliance. Consider the following key indicators:

• • Dossier requirements and the capability to harmonise components for use in multiple markets

• • Strong cGMP manufacturing operations with a demonstrated history of continuous improvement

• • Effective documentation and filing data management with a focus on integrity • Regulatory responsiveness and efficiency in filing processes

• • Established relationships with regulatory bodies and a comprehensive understanding of their requirements

4. Personnel Having the right people involved is crucial for managing successful tech transfers between organisations. Look for external partners employing talented individuals with proficient project management and operational skills as well as scientific expertise.

FAQs-

What is a technology transfer in the pharmaceutical industry?
A technology transfer, or tech transfer, is the process of transferring knowledge about a drug product and its established manufacturing processes from development to commercial production or between manufacturing sites. This transfer enables consistent product realization and supports manufacturing, control strategies, and process validation.

Why is technology transfer critical in pharma and biotech outsourcing?
Technology transfer is essential for successfully scaling drug development and manufacturing, especially when production moves between sites, companies, or to contract manufacturers. It helps manage risks, maintain product quality, and ensure smooth transitions, but it is complex, costly, and time-consuming.

What expertise is required for a successful technology transfer?
Successful tech transfer requires expertise in knowledge sharing, communication, cross-company cooperation, project management, quality assurance, and regulatory compliance. It also demands robust documentation, transparency, and clear alignment of expectations among all stakeholders.

What are the main stages of a technology transfer?
A tech transfer typically involves three main stages: defining and scoping the project by gathering knowledge and assessing risks; planning by developing schedules, refining protocols, and managing resources; and execution by tracking progress, analyzing data, implementing adaptive actions, and maintaining transparent reporting.

How can the technology transfer process be accelerated without compromising quality?
Accelerating tech transfer can be achieved through strategies like using digital twins for virtual experiments, applying Quality by Design (QbD) principles, establishing dedicated multidisciplinary project management teams, utilizing standardized operating procedures and documents, and developing comprehensive technical transfer protocols.

What factors should be considered when choosing a contract development and manufacturing organization (CDMO) for technology transfer?
Key considerations include the CDMO’s geographic footprint and understanding of the market, technological capabilities and reliability, strong regulatory compliance and documentation processes, and having skilled personnel with project management and scientific expertise to ensure successful tech transfers.