Navigating Technology Transfer in Pharma and Biotech

Technology transfer, or “tech transfer,” refers to the process of moving a drug’s manufacturing process from one setting to another.

In biotech especially, this is critical because many companies don’t operate their own manufacturing facilities and rely on contract partners. The process typically begins at lab scale. Once the manufacturing method is established, it must be transferred to a contract manufacturing organization (CMO) or internal site for scale-up.

From there, the process continues to evolve, first to produce clinical trial material, then to support larger-scale production as programs advance.

And it rarely happens just once. Companies often secure a backup CMO, move to a larger commercial-scale facility, or transfer manufacturing as part of a licensing agreement with a large pharmaceutical company. Each move requires another tech transfer. That’s why comprehensive documentation, SOPs, and validated processes are essential: reproducibility must be built in from the start.

Common scenarios include:

• Academic lab to industry
• Internal lab to manufacturing site
• Transfer to a CMO
• Transfer between CMOs
• Transfer to a commercial-scale facility
• Transfer to a licensing partner

While it may sound like following a recipe, it’s rarely that simple.

A useful analogy is pancakes. If everyone uses the same boxed mix, the pancakes should turn out the same, but every kitchen is different: stove temperatures vary, pans differ, oils behave differently. The outcomes change.

Pharmaceutical manufacturing is exponentially more complex. Small differences in equipment, environmental conditions, raw materials, or operator experience can materially impact results.

It depends on the stage. Early-stage transfers, from lab to small-scale manufacturing, are typically led by R&D teams transferring core process knowledge.

As scale increases, additional stakeholders become central:

• Process development teams
• Manufacturing site operations
• Quality assurance (QA)
• Quality control (QC)

QA and QC are particularly critical. Ultimately, tech transfer is a collaboration between process experts and quality teams to ensure that what worked in one environment can be reliably reproduced in another.

Quality control and data integrity become increasingly important as volumes grow.

The larger the scale, the harder it is to maintain consistency. Even within the same facility, batch-to-batch variability can occur. Small molecules are generally more controllable, but biologics, peptides, and advanced modalities introduce more variability.

It often takes multiple runs, and sometimes failures, to optimize a process at scale. Those iterations cost time and money, so development plans must account for that reality rather than assume a linear path.

Every scale-up carries risk. The earlier teams identify vulnerabilities, the better.

Frequent challenges include inadequate documentation, limited site experience with the modality, process variability during scale-up, and gaps in GMP adherence.

Importantly, simply following current Good Manufacturing Practice (cGMP) guidelines does not guarantee a successful run. Experience matters.

Selecting the right manufacturing partner, one with deep technical expertise and strong quality systems, can significantly reduce risk. But even then, companies should build contingencies into timelines. Setbacks are common, and planning for them is a mark of operational maturity.

They affect all four. As production scales, cost per gram generally decreases. However, if a commercial-scale batch fails, the financial impact can be enormous.

That’s why it’s preferable to uncover and resolve issues at smaller scale. Strong preparation, robust quality systems, and thoughtful partner selection can dramatically improve commercial outcomes.

Poor tech transfer decisions can delay timelines, increase costs, compromise quality, and jeopardize regulatory approval.

Manufacturing complexity has increased dramatically over the past two decades. Historically, most drugs were small molecules. Today, companies are developing biologics, cell therapies, RNA-based therapies, and other advanced modalities, each requiring specialized facilities, equipment, and expertise.

Global manufacturing adds another layer of risk. Regulatory scrutiny of overseas facilities has intensified at various points, including from the US Food and Drug Administration. In some cases, companies have discovered mid-development that a CMO was not fully compliant with cGMP standards.

If that occurs during clinical development, it’s disruptive. If it happens at the commercial stage, it can be catastrophic, potentially blocking product sales in key markets.

Founders should prioritize selecting experienced, compliant CMOs, independently verifying cGMP readiness, maintaining robust documentation for future transfers, and avoiding cost-driven shortcuts.

Choosing the lowest-cost partner without strong quality systems can create outsized downstream risk.

The introduction to this interview includes text that has been created with the assistance of generative AI and has undergone editorial review before publishing. Technology Networks' AI policy can be found here.