Technology transfer in the pharmaceutical industry is a key step of the manufacturing process. It involves the handover of product information from research and development - either from the client to the manufacturer, or, in the case of large scale commercial manufacturers, within the organisation itself.
What is technology transfer in pharmaceuticals?
Technology transfer is a structured process that involves handing over documented knowledge and experience from product development: moving it from the sending unit (SU) to the receiving unit (RU). According to the World Health Organisation, transfer of technology is defined as "a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacture sites".
In the pharmaceutical industry, technology transfer occurs either from a research facility to a manufacturing company or between manufacturing sites. The process involves preparing and handing over documents, analytical methods, and test results for consistent product quality and compliance.
The role of technology transfer in pharmaceutical manufacturing
Technology transfer is a critical part of ensuring that the manufacturing process of the product can be replicated at scale for consistent results.
Initial formulation for pharmaceutical manufacturing is carried out at a small scale for testing. During this process, researchers identify specific requirements or limitations of the product's formulation. For example, researchers may discover that the formula must be kept at a certain temperature range to prevent unwanted chemical reactions.
Documenting and handing over these findings to manufacturers means ensuring that the finalised process can be repeated in the same format. The sensitive nature of pharmaceutical products means that any deviation in percentages, concentration, or order of processes (regardless of how small) can cause the product to be unfit for sale and consumption.
Technology transfer is also an important aspect of fulfilling regulatory compliance with global Good Manufacturing Practices (GMP) and pharmaceutical authorities such as Australia's Therapeutic Goods Administration (TGA). By carefully documenting each stage of the manufacturing process from raw material sourcing to quality checks, manufacturers can show evidence of regulatory compliance and quality assurance.
What is documented in a technology transfer report?
Technology transfer documentation will include:
- A formal document outlining a list of defined roles and responsibilities for both the receiving unit (RU) and the sending unit (SU)
- Product information (name, formulation, dosage form, target market)
- Comparison of production capability between SU and RU (equipment and facility information, team qualifications
- Information on raw material sourcing
- A step-by-step manufacturing process with clearly indicated critical parameters, often in the form of a process flow diagram
- Quality testing procedures for raw materials, intermediates, and final products
- A validation report on a test batch of products from the RU (compared with a report from the SU to assess for consistency in results)
- Identification of risks and a management plan to address potential issues during transfer
- Regulatory and compliance information with regards to GMP and TGA regulations
A technology transfer will be considered successful when the SU makes the necessary information available to the RU. The RU ensures that the information is implemented accordingly to achieve a consistent product outcome.
What does technology transfer mean for businesses?
While pharmaceutical manufacturers are familiar with the transfer of technology, businesses who engage them for production and product development are usually less informed.
The most common application of technology transfer applies when businesses that are looking to switch options from one pharmaceutical manufacturer to another, whether due to budgetary concerns or quality issues. Documentation of the manufacturing process, required equipment, and raw materials will need to be passed on from the previous manufacturer to the new one.
Pharmaceutical manufacturing clients are not required to facilitate technology transfers - the process will be arranged between both SU and RU. However, the success of the transfer will impact the quality of the final product, which is why businesses need to be aware of the technology transfer process.
To ensure the technology transfer's success, businesses must work with the right manufacturer who can facilitate the process with as little risk as possible. Contract development and manufacturing organisations (CDMOs) are the ideal choice as they often have dedicated tech transfer teams of researchers and production specialists to manage handovers between internal sites or external manufacturers, even across countries.
By minimising gaps in technology transfer, CDMOs like Lipa Pharmaceuticals offer businesses greater reliability and consistency for the desired supplements. Lipa Pharmaceuticals is a local pharmaceutical manufacturer in Australia for complementary medicines such as vitamins, health food supplements, and over-the-counter medicines.
We have in-house research and quality testing teams that ensure accuracy in all aspects of technology transfer. If you are looking for a manufacturer in Australia that can take on production for your pharmaceutical products, reach out to us today to find out how we can help.