In the past, technology transfer (tech transfer) mainly referred to standard transfer or technology instruction from technology department to production department within the same company. Now tech transfer is the process by which an original innovator of technology makes its technology available to commercial partner who will exploit the technology. Tech transfer is important to upgrade drug quality as designed during R&D to be a final product in manufacture. It is helpful for improving efficiency in process, maintaining quality of products, achieving standardized process which facilitates cost effective production. “SU” (sending unit) and “RU” (receiving unit) are two primary parties involved in any technology transfer processes. SU (also known as the transferring laboratory) is the source or originating laboratory of the analytical procedure, and RU (also known as the receiving laboratory) is the internal or external laboratory qualified on the analytical procedure.
BOC Sciences has several decades’ records of successful technology transfer to support extensive of biologics and clinical stages. Our chemists are experienced in achieving the transformation of knowledge and methods of manufacturing from laboratory to industry.
Below is a list of detailed documentation we offer for your tech transfer (include but not limited to the following):
Process transfer is an important component of technology transfer, which is the systematic exchange of all technical information from SU to RU. During every manufacturing process transfer, the technical team of SU has the knowledge of the product and process to be transferred (critical steps, critical quality attributes and critical process parameters, etc.); and the technical team of RU has knowledge of the available technologies and equipment at the receiving manufacturing plant.
The use of analytical method is essential to full characterization of QC testing during drug manufacturing. Analytical method transfer is generally performed between two companies' testing laboratories, or it might be done even one company with two different sites, or with two laboratories within one company. Analytical method transfer aims to verify a certain laboratory’s capability of performing the analytical testing method’s intended use. Successful transfer of these analytical methods is a critical component of technology transfer.
Packaging transfer operations should follow the same procedural patterns as those of the production transfer. Transferred packaging information from SU to RU usually contains the specifications for a suitable container or closure system, and any other relevant information on design, packing processing or labeling requirements, as well as tamper-evident and anti-counterfeiting measures needed for qualification of packaging components at the RU.
Documentation transfer usually refers to documents of tech transfer for both transferring and transferred parties. The raw data of the documents (such as development report) need to be prepared and compiled according to purposes, and should be always easy access and traceable. For successful technology transfer, preparing product specification with detailed information of product (drug substances or drug products) is more preferable. Then the technology transfer is proceeded according to the technology transfer plan established on the basis of this specification.
We have extensive experience in transferring processes and analytical methods from the research and development sites to commercial manufacturing sites. Collaborating with Research and Development, and Manufacturing Technical Operations, we can ensure a successful technology transfer and a robust final manufactured product.