Technology transfer in contract pharmaceutical manufacturing – from laboratory to industrial scale

A formulation that works perfectly in the laboratory in a batch of several hundred grams does not necessarily perform the same way on a production line manufacturing hundreds of thousands of capsules. Transferring a process from small scale to industrial production is one of the most underestimated, and at the same time one of the riskiest, stages on a medicine’s path to market. It is known as technology transfer.

For a brand owner using contract pharmaceutical manufacturing, technology transfer is the point at which product knowledge passes from the development team to the manufacturer. If this stage is carried out thoroughly, further validation and registration become a matter of time. If it is treated superficially, the project becomes bogged down in repeated batches and incorrect parameters. This article explains what a well-managed transfer looks like.

What technology transfer is and why it is often the weakest link

Technology transfer is the documented transfer of product and process knowledge between the site where a medicine was developed and the site where it will be manufactured. The objective, as stated in the ICH Q10 guideline, is to transfer product and process knowledge so that it forms the basis for the manufacturing process, the control strategy, and the approach to validation. It is therefore not about sending a file with the formulation, but about recreating the entire understanding of the product at a new site.

The problem is that many parameters that are important at industrial scale do not reveal themselves in the laboratory at all. Mixing time, compression force, airflow in a fluid-bed dryer, or the behavior of granules during pneumatic transport – all of these change with scale. That is why transfer requires not the copying of settings, but an understanding of which parameters are critical to quality and which can be safely adjusted.

Stages of technology transfer step by step

A well-organized transfer follows a structured sequence in which each stage is closed with a specific document:

• transfer of development documentation – the transferring party provides the formulation, process description, specifications, analytical methods, and product development history, including the Quality Target Product Profile (QTPP);
• gap analysis and risk assessment – the receiving team compares the process requirements with the capabilities of its own facility and identifies differences in equipment, scale, and utilities;
• technical batches and optimization – the manufacturer runs trial batches, fine-tuning parameters to industrial scale and confirming that the product meets the specification;
• transfer of analytical methods – the quality control laboratory confirms that the test methods work correctly on the new equipment and produce results comparable to those of the transferring party.

Only after these stages have been completed does the facility proceed to formal manufacturing process validation. Transfer and validation are two different, consecutive activities – attempting to combine them or skipping the transfer stage almost always leads to problems during validation batches.

Scale-up – where problems most often arise

Scale-up is not simply multiplying the batch size by a factor. As the batch size increases, the physical conditions of the process change, and some of them can surprise even an experienced team. The most common pitfalls include:

• mixing and uniformity – the time needed to obtain a homogeneous mixture does not increase linearly with scale, and insufficient mixing or segregation threatens the active substance content;
• granulation and drying – fluid-bed parameters at larger scale affect moisture distribution and granule size, which in turn influence flowability and compressibility;
• tableting and capsule filling – higher machine speeds change the contact time and the forces acting on the material, which may affect weight, hardness, and release.

Controlling these variables requires not only equipment, but also knowledge of raw material behavior. The selection and quality control of ingredients, which we describe in the article on pharmaceutical raw materials, has a direct impact here on batch-to-batch reproducibility at industrial scale.

Transfer plan and communication between the parties

The success of a transfer is determined not only by technology, but also by organization. The foundation is the technology transfer plan – a document that defines the scope of knowledge to be transferred, the division of roles between the transferring and receiving parties, the schedule, and the criteria for considering the transfer complete. Without such a plan, the project falls apart into undocumented arrangements that no one can later reconstruct.

Transfer acceptance criteria are equally important. Teams must establish in advance which technical batch results constitute success – which quality parameters, what comparability of the dissolution profile, and what level of alignment of analytical methods. A transfer is considered closed only when the receiving party independently reproduces a product that meets these criteria, not when the last document has been sent.

Ongoing communication is also essential. The best transfers are managed by joint teams that meet regularly, share tacit knowledge (the kind that is not written down in procedures), and respond quickly to deviations. An experienced CDMO partner brings value here that no documentation can provide – they know where a given type of formulation usually causes difficulties and how to prevent them before the problem appears.

Before starting the transfer, it is also worth checking two formal issues on the side of the receiving facility: whether its manufacturing authorization covers the required pharmaceutical form – and what scope of post-approval variations will be necessary after the transfer is completed if the product is already registered. In this latter area, we support clients as part of our medicine registration service.

Entrust technology transfer to an experienced team

Efficient technology transfer is the result of cooperation between technologists who have followed this path many times. Laboratorium Galenowe Olsztyn, part of the Eubioco group, has the development and production facilities needed to take your product from laboratory scale, through technical batches, all the way to validated industrial production – all in accordance with GMP standards. After thorough transfer and validation, the natural next step is preparing the product for market launch. Are you planning to transfer the production of a medicine to a trusted partner? Contact us at sprzedaz@eubioco.eu to discuss the scope of the transfer and the project schedule.

BIBLIOGRAPHY

1. International Council for Harmonisation (2008). ICH Q10 – Pharmaceutical Quality System. [online] Available at: https://database.ich.org/sites/default/files/Q10%20Guideline.pdf [accessed online: 13.07.2026]
2. World Health Organization (2011). WHO guidelines on transfer of technology in pharmaceutical manufacturing. WHO Technical Report Series, No. 961, Annex 7. [online] Available at: https://www.who.int/docs/default-source/medicines/norms-and-standards/guidelines/production/trs961-annex7-transfer-technology-pharmaceutical-manufacturing.pdf [accessed online: 13.07.2026]
3. World Health Organization (2022). WHO guidelines on technology transfer in pharmaceutical manufacturing. WHO Technical Report Series, No. 1044, Annex 4. [online] Available at: https://www.who.int/publications/m/item/trs1044-annex4 [accessed online: 13.07.2026]
4. International Council for Harmonisation (2009). ICH Q8(R2) – Pharmaceutical Development. [online] Available at: https://database.ich.org/sites/default/files/Q8%28R2%29%20Guideline.pdf [accessed online: 13.07.2026]