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

Every drug that reaches patients survives at least one tech transfer: the handoff of process and product knowledge from lab to plant, or from one manufacturing site to another. Done well, it protects quality, timelines, and patient supply. Done poorly, it is one of the most common reasons drug launches slip by months.

This guide breaks down what a pharmaceutical technology transfer involves in 2026, including the documents in a transfer package, the regulatory guidelines that shape it, the stages of the process, and what to look for in a CDMO partner.

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. 

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.

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:

Latest Tech Transfers News-

Internal vs. External Technology Transfer

Technology transfer can happen internally (lab to pilot plant, or between two sites owned by the same company) or externally, most commonly when a sponsor transfers a process to a CDMO. In WHO and industry terminology, the originating party is the sending unit (SU) and the party taking on the process is the receiving unit (RU). The core knowledge-transfer principles are the same either way, but external transfers typically add contractual steps, such as confidentiality agreements, Master Service Agreements, and Quality Agreements, before any technical work begins, which is a large part of why external transfers tend to add lead time versus internal ones.

Some external transfers also move between two sites owned by the same CDMO. Jeff Mason, VP and Head of US Sales at Samsung Biologics, described this dual-site scenario on the PharmaSource podcast at CDMO Live Europe 2026:

What we’re seeing is a trend, a lot of our customers have an increased demand for dual-site tech transfer because of accelerated timelines and hedging supply chain risk for commercial. But this doesn’t allow a lot of time to process-optimize or align critical quality attributes across sites.- Jeff Mason, VP and Head of US Sales at Samsung Biologics

(See the full case study at the bottom.)

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. 

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

Communication discipline matters as much through execution as the technical work itself. As Joseph “Joe” Bomba, Director of CDMO Strategic Partnerships at Lannett CDMO, put it in a PharmaSource article published in partnership with Lannett CDMO:

After facilitating hundreds of tech transfers, I can tell you that timeline failures rarely stem from technical challenges. They come from misaligned expectations and poor stakeholder coordination. The CDMOs that consistently deliver on schedule are masters of communication, not just manufacturing.

The Technology Transfer Package (TTP): What’s Inside

A Technology Transfer Package (TTP) is the key working set of documents that lets a receiving site reproduce a process to the same quality standard as the sending site. TTPs communicate process information and knowledge to their recipients, the vendors that sponsors select to perform the work. Per WHO’s guidelines on technology transfer in pharmaceutical manufacturing, exact contents depend on the product, its lifecycle stage, and the scope of transfer, but a typical package includes:

Document	Purpose
Technology Transfer Plan/Protocol	Defines scope, milestones, responsibilities, and timelines
Process development reports	Describes the process as run at lab/pilot scale, including critical in-process controls
Master batch record (or process narrative)	Step-by-step manufacturing instructions
Analytical method documents	Procedures, validation data, and acceptance criteria for all assays
Materials specifications	Raw material identities, grades, suppliers, and QC tests
Stability data	Accelerated and real-time stability results supporting shelf life
Quality specifications	Release and stability specifications the product must meet
Risk assessment / FMEA	Identifies critical process parameters (CPPs) and critical quality attributes (CQAs)
Regulatory CMC documentation	Relevant sections of the IND/CTA/NDA/BLA/DMF
Quality Agreement	Defines QA/QC responsibilities and change control between sending and receiving sites

Sponsors should provide raw data alongside summary reports, not summaries alone; incomplete or summary-only packages are one of the most commonly cited causes of delay in tech transfer case reporting across the industry. A complete package is also more than a stack of documents. As Amy Gamber, Executive Director, Lifecycle Lead at Kyverna Therapeutics, explained on the PharmaSource podcast:

“It’s sort of like you’re walking through a new house. Here’s the things that go smoothly, here are the things we often struggle with. This is what good looks like, this would be a warning flag. That context takes it from being just a set of documents to helping them understand.” She also stresses that not every process parameter carries equal weight: “You need to call out the parameters that are more critical to the process, and the ones where you have some flexibility. That way you’re setting your CDMO up for success.” On the value of person-to-person transfer over documentation alone: “It is much less expensive to pay for that travel than to pay for six months of delayed tech transfer and failed batches and all the materials.”

Standardised procedures and a common language help contract manufacturers accommodate varying client needs consistently. The five-part framework below reflects how a TTP typically moves through a transfer:

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.

Common Tech Transfer Failure Points (and How to Avoid Them)

Failure mode	Typical impact	How to mitigate
Incomplete or summarized-only documentation	Receiving site must regenerate data; delays of weeks to months	Send raw data alongside summaries; use a master document index and confirm receipt
Rushed or incomplete analytical method transfer	Out-of-spec batches; inability to reliably measure quality	Plan method transfer early with a written protocol and defined acceptance criteria
No single point of coordination	Information sent piecemeal to different contacts; conflicting versions	Appoint a dedicated Tech Transfer Project Manager with decision authority
Skipped or under-scoped risk assessment	Process surprises discovered late, when they are expensive to fix	Run a formal FMEA-style risk assessment at kickoff and update it through execution
Assuming legacy methods and specs still apply	Regulatory or impurity requirements may have changed since original development	Review current guidelines (nitrosamines, elemental impurities, and similar) before finalizing scope
Under-resourced subject matter expert involvement	Missed critical parameters, especially for complex modalities	Involve process, analytical, and QA SMEs from both sites from kickoff, not just at handoff

Warning Signs a Transfer Is Going Off the Rails

Beyond the failure modes above, Amy Gamber of Kyverna Therapeutics outlined four behavioral red flags on the PharmaSource podcast, “Breaking the Death Spiral”, drawn from experience rescuing failing CDMO relationships:

• Timelines that don’t make sense. “If people can’t explain how they came up with particular timelines, that’s a problem. If you ask for a plan and they say, ‘I’ll get back to you,’ particularly if you’ve asked a couple of times, that’s also a problem.”
• Glossing over issues. “You have a batch failure. Everyone talks it up, ‘It’s operator error.’ We close it quickly, we move on, and then it happens again, and then it happens a third time. At that point, you’re losing months.”
• People talking at each other instead of with each other. “Talking at each other looks like, ‘It’s not my responsibility, somebody else fix it.’ Talking with each other is ‘Let’s figure out how we’re going to solve it first, then we’ll figure out the contractual issues later.'”
• Leadership disengagement. “Where’s the site leadership? Are they showing up? If they’re not, that’s a signal that you are not a priority. That makes teams less likely to escalate when they have issues.”

Catching these signals early matters because, as Gamber notes, once a transfer is in serious trouble, “you’re not talking about a technical problem. You have a business risk that you’re trying to manage.”

Complexities of Technology Transfer

Common challenges for tech transfers include:

1. 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.
2. 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.
3. 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.
4. 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:

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

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

Regulatory compliance– Evaluating a CDMO partner’s potential requires a thorough understanding of their ability to proactively maintain regulatory compliance.

“Increasingly, sponsors expect a CDMO’s quality system to function as a seamless extension of their own, since the marketing authorization holder remains accountable for defending that system to regulators.- Jens Klein, Siegfried

Read the full expert discussion: Where Pre-Filled Syringe Tech Transfers Go Wrong: Lessons from Siegfried and SKAN on Moving to Commercial Supply Under Annex 1

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

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.

Case Studies: What Tech Transfer Looks Like in Practice

A 90-Day Dual-Site Biologics Transfer At CDMO Live Europe 2026, Jeff Mason, VP and Head of US Sales at Samsung Biologics, described how the company compressed a dual-site biologics tech transfer to a first GMP batch in just 90 days. The driver, he said, is client demand: “What we’re seeing is a trend, a lot of our customers have an increased demand for dual-site tech transfer because of accelerated timelines and hedging supply chain risk for commercial.”

Samsung Biologics’ approach rests on parallelizing work that is traditionally sequential, running gap assessment, analytical readiness, and process control strategy development concurrently at both sites from day one, combined with a standardized analytical platform across facilities. “Our plants are essentially carbon copies of each other, same quality platforms, same raw material management systems,” Mason explained. “That’s what allows us to apply one process control strategy not just across two sites, but across all five plants if needed.”

In one case, an internal transfer initiated in late November delivered a first GMP batch at the receiving site 90 days later, with a full process performance qualification (PPQ) campaign completed across both facilities within the year, despite the receiving plant’s bioreactors running at 15,000 liters versus 10,000 liters at the sending site. Cell culture profiles and final product titers remained comparable across the scale difference, illustrating that scale differences need not compromise comparability when gap assessment and analytical readiness are run in parallel rather than sequentially. Samsung Biologics has described running five such dual-site transfers simultaneously, with the explicit goal of shortening the 90-day benchmark further as process knowledge accumulates.

Frequently Asked Questions-

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.

What is a Technology Transfer Package (TTP)?

A TTP is the complete set of documents and data, including process development reports, batch records, analytical methods, stability data, risk assessments, and specifications, that a sending site provides to a receiving site so the receiving site can reproduce the process to the required quality standard.

Which ICH guidelines apply to pharma technology transfer?

ICH Q10 explicitly places technology transfer within the pharmaceutical quality system lifecycle, while ICH Q8 and Q9 support the knowledge and risk-management foundations behind a transfer. ICH Q12 addresses post-approval change management, ICH Q13 addresses continuous manufacturing, and ICH Q2(R2)/Q14, adopted in November 2023, govern analytical method validation and development, which are central to analytical method transfer.

How can the technology transfer process be accelerated without compromising quality?

Accelerating tech transfer can be achieved through strategies such as applying Quality by Design (QbD) principles, establishing dedicated multidisciplinary project management teams, using standardized operating procedures and documents, developing comprehensive technical transfer protocols, and, increasingly, using digital twins and AI-assisted gap analysis to simulate scale-up before committing physical materials and plant time.

How much does a pharma tech transfer cost, and how long does it take?

Costs and timelines vary widely by modality, scope, and whether the transfer is internal or external. A 2024 Deloitte report found the average cost of a single transfer runs $5 million to $8 million over its lifespan, with companies that execute well cutting that cost by up to 30%. On timelines, McKinsey research found sterile dosage form transfers typically take 18 to more than 30 months, with external transfers generally taking longer than internal ones. Well-run, digitally enabled programs have compressed this substantially for specific, defined scopes (see the Samsung Biologics 90-day case study above).

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 skilled personnel with project management and scientific expertise, as well as the quality of communication and cultural fit, which practitioners consistently describe as being as important as technical capability.