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Technology Transfer in Pharmaceutical Industry

Technology Transfer 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 manufacturing sites”.

A proper technology transfer (TT) is both essential and important to drug discovery and development for new medicinal products. It is also required to upgrade drug quality planned during research development and to final product during manufacturing as well as to guarantee that stable quality is transferred.
  • It is a systematic procedure that is followed in order to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible and authorized party. Technology transfer embodies both the transfer of documentation and the demonstrated ability of the receiving unit (RU) to effectively perform the critical elements of the transferred technology, to the satisfaction of all parties and any applicable regulatory bodies.
  • The transfer of technology is considered as both fundamental and significant to the drug discovery and development process for any new medicinal entity. This process is important for to elucidate necessary information for technology transfer from R & D (Research & Development) to PDL (product development laboratory).

Why technology transfer is required in Pharmaceutical Industry?
  • Technology transfer refers to the processes that are needed for successful progress from drug discovery to product development, to clinical trials to full-scale commercialization or it is the process by which a developer of technology makes its technology available to commercial partner that will exploit technology.
  • Technology transfer involves manufacturing drug product with increasing batch sizes on larger equipment or using continuous processing on pilot scale equipment. Generally scale up involves the transfer of technology and the transfer of knowledge that has been accumulated during the small scale development of product and processes.
  • In the pharmaceutical industry, technology transfer by collaborating with other departments and other organizations to commercialize a pharmaceutical product is a common process.

Importance of Technology Transfer in Pharmaceutical Industry
  1. To elucidate necessary information to transfer technology from R&D to actual manufacturing by sorting out various information obtained during R&D.
  2. To elucidate necessary information to transfer technology of existing products between various manufacturing places.
  3. To exemplify specific procedures and points of concern for the two types of technology transfer in the above to contribute to smooth technology transfer. This is applies to the technology transfer through R&D and production of drug substances or drug products and the technology transfer related to post-marketing changes in manufacturing places.

Reasons for Technology Transfer
  1. Lack of manufacturing capacity: The developer of technology may only have manufacturing equipment which is suitable for small scale operation, and must collaborate with another organization to do large scale manufacturing.
  2. Lack of resources to launch product commercially: The original inventor of technology may only have the resources to conduct early-stage research such as animal studies and toxicology study, but doesn’t have the resources to take technology through its clinical and regulatory phases.
  3. Lack of marketing and distribution capability: The developer of technology may have fully developed the technology and even have obtained regulatory approvals and product registrations, but it may not have the marketing and distribution channels.
  4. Exploitation in a different field of application: Each partner may have only half of the solution i.e. the developer of the technology might be capable of exploiting the technology itself in the field of diagnostic applications and may grant exploitation right to commercial partner for the exploitation of therapeutics application.

Technology Transfer in Pharmaceutical Industry
  • Technology transfer is the process by which the manufacturing process and analytical method are transferred from one manufacturing unit to another unit or from R&D to manufacturing unit.
  • Technology transfer from R&D to manufacturing site is critical because of the scale-up of the product from pilot batch to large-scale commercial batch. A typical technology transfer process can be divided into production part, quality control part and documentation part.
A.  Production: Technology Transfer
  • Receiving unit and sending unit both should develop the product transfer protocol jointly to transfer the product related information. Information should be transferred according to the technical expertness of the staff and the manufacturing site capabilities to run the process smoothly.
1. Raw Materials:
  • The material used for manufacturing on receiving unit should have consistency with the material used at the sending unit. The properties of the raw material those can alter the quality of the product should be identified.
i.  Active Pharmaceutical Ingredients (API):
Sending unit should provide the drug master file (DMF) and other related information of the active materials. It may include the following information:
  • Flowchart of the manufacturing process of the drug material
  • Physical properties including bulk and tap density
  • Moisture content including water activity
  • Bioburden, endotoxin and sterility as required
  • Solubility and pH of solution
  • Particle size distribution and its dissolution profile
  • Manufacturer and the supply chain of the material
  • Other information like heat, light and moisture sensitivity
ii.  Excipients:
Excipients also have the considerable effect on the final product so their detailed information should also be provided by the sending unit to receiving unit. It may include the following information:
  • Viscosity of material
  • Flowchart of the manufacturing process of the drug material
  • Physical properties including bulk and tap density
  • Moisture content range
  • Melting range
  • Bioburden, endotoxin and sterility as required
  • Ion strength of material
  • Solubility and pH of solution
  • Specific gravity
  • Particle size distribution and its dissolution profile
  • Manufacturer and the supply chain of the material
  • Compliance with
  • TSE and BSE requirements
  • MSDS and heat, light and moisture sensitivity

2. In-process Materials
Sending unit should provide the detailed information of manufacturing process, physical description, specification and in-process controls.

3. Finished Products
  • History of the development of the product should also be provided for the further development or process optimization after the successful technology transfer.
  • Information regarding the environment, health and safety should also be provided to the receiving unit. It should also include the information on product quality review, validation, stability and environmental conditions for manufacturing.
  • Generally, trial batches are taken at the receiving unit to test the manufacturing parameters and capability of the manufacturing process before running the validation batch.

4. Packing Process
All the information regarding the packing should be transferred as the manufacturing process. It includes the specification of foils or containers and closures, and other related information as design labeling, artwork and drawings.

5. Cleaning Process
  • To prevent the contamination in the pharmaceutical products, it is essential the follow the adequate cleaning procedure. It can minimize the risk of cross-contamination during manufacturing. 
  • Receiving unit should validate the cleaning procedure and sending unit should provide the required information such as existing cleaning procedure, the solubility of all materials, therapeutic dose, the toxicity of the API, cleaning agents and recovery studies.

6. Manufacturing Facility
Sending unit should provide the information related to the facility design.

i.  Premises
  • It should include the layout of facility, buildings, utility services, fire risk, health and safety requirements for operators and environmental issues.
ii.  Equipment
  • list of required equipment with their make and models should be provided by the sending unit. It should include the manuals, drawings and cleaning, operating and maintenance procedures. IQ, OQ and PQ of the equipment should be done by the receiving unit.

B.  Quality Control: Analytical Method Transfer
  • The analytical method has its own importance because the manufactured product shall be tested by the developed analytical method and accuracy in the analytical method can save time. Receiving unit should implement the method of analysis for the finished product, raw materials, packing materials and cleaning residues before the starting of the process validation.
  • Analytical method transfer protocol should be prepared including responsibilities of both sanding unit and receiving unit, the specification of product, acceptance criteria, interpretation of results, report formats, reference standards and deviations during analysis. Training should be provided to the analysts and should be documented in training record.

C.  Documentation
  • Every step followed during the technology transfer process should be documented and a summary report should be prepared to contain the conclusion of the technology transfer.
  • Discrepancies found during the process should be listed and should be resolved by taking the appropriate action. 
  • Following documents should be prepared during the successful tech transfer.
  1. Technology transfer protocol
  2. Facility qualification protocol and report
  3. Equipment qualification protocol and report
  4. Process validation protocol and report
  5. Cleaning validation protocol and report

Annex 7 - WHO guidelines on transfer of technology in pharmaceutical manufacturing

 

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