• search
Country
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Pharma API Technology Transfer

Pharma API Technology Transfer

Ensuring hassle-free and risk-free scale up.

Technology transfer of API from lab to plant is a very critical process for successful API delivery to the client. Diligent planning and execution are required right from selecting plant and equipment, obtaining manufacturing slots, reviewing product development and ensuring the right documentation is delivered on time. 

At Aurigene, we have a cross-functional team of analysts, chemists, engineers and quality specialists who lead the process of technology transfer. We have extensive experience of scaling up 500+ projects and 1500+ process steps. Our technology transfer procedure from the laboratory to the respective manufacturing facility includes: 

Process safety clearance & confirmation of equipment train 

Analytical method transfers for raw materials, intermediates, in-process tests, and final compound 

Sharing of process understanding, preparation, and approval of Batch Production Records (BPR)

Speak to our experts

The following are the steps followed in technology transfer:

Process Safety Clearance and Confirmation of Equipment Train

At Aurigene, we believe in a safe and sustainable manufacturing approach. Controlling chemical reactions and associated hazards is an important aspect of chemical manufacturing. Almost 30% of incidents are caused by chemistry issues due to inadequate study during the developmental phase. Hence, we strive to mitigate hazards and associated risk in scale up by practicing process safety to a great extent.

At Aurigene, there is a very structured methodology for performing process safety. The process includes:

  • Literature data and calculations
  • Basic screening tests
  • Isothermal calorimetry to find out heat of reaction for process
  • Adiabatic calorimetry to examine the runaway potential of reactions and compounds and specific measurements like vent sizing calculations
  • Generating Hazard Evaluation Report (HER) for scale up assurance
  • Based on the safety evaluation, appropriate engineering controls will be adopted prior to batch processing and they will be captured in the Process Hazards Analysis (PHA) and Process Safety Information (PSI) report.
  • Pre-Startup Safety Review (PSSR) will be carried out prior to the start of the batch as a checklist on safety to ensure whether all the safety recommendations are being implemented in the specific manufacturing unit or not. Only after that, batch start-up clearance is given on the specific equipment train.

Analytical Method Transfer for Raw Materials, Intermediates, In-process Tests and Final Compound

We have internal Standard Operating Procedures (SOP) which govern the analytical method transfer process. Transfers shall be initiated with pre-approved protocols, followed by batch analysis. SOP guides will fix the acceptance criteria for individual tests to conclude the completion of analytical method transfer.

Decision on Slots at The Plant

After completion of process optimization, we propose the technology transfer date in consultation with the technology transfer team and technology absorption team.

Stage Gate Meetings

PR and D, AR and D, and Process Engineering shall submit the development reports to QA three working days before the proposed technology transfer date. QA shall conduct a gate meeting at least two days before the technology transfer date to review the product development of API using a gate checklist (based on the scope of the project, regulatory submissions/GMP requirements etc.) Timelines shall be provided for the pending action items in the gate checklist. Head QA or designee shall decide on the clearance for the technology transfer depending on the pending action items.

Technology Transfer

Technology transfer shall be conducted based on an optimization study or familiarization report. QA shall hand over all documents along with the technology transfer checklist to the concerned plant QA.

The data generated (document transfer) at the development center will be transferred to the manufacturing facility which would include:

  • Raw material list along with specifications and method of analysis
  • Optimization report or finalized process for the manufacturing
  • Holding study data of reaction mass, wet or dry intermediates
  • Recovery or reuse of solvent (as applicable)
  • Reprocessing or rework procedures (as applicable)
  • Details of analytical methods for in-process controls, intermediates and final compound
  • Reference standards
  • Process flow diagram
  • Equipment justification reports
  • Details of process safety evaluation and the recommendations

Based on the technology transfer document batch production record to be generated prior to manufacturing start up

Approval of BPR and Start of Manufacture

After completion of the technology transfer, the required Batch Production Records (BPR) will be generated based on the details provided by the technical team and further will be reviewed and approved by the Quality Assurance (QA) team. Post-completion of the BPR approvals, manufacturing will follow.

We will share the BPR (before it is reviewed and approved by the internal QA team) with the customer team for information purposes only. However, if there are any specific comments from the customer, the BPRs will be further refined as required.

Why Aurigene Pharmaceutical Services?

Experience in scale up of 500+ projects or 1500+ stages

Availability of fast accessible non-GMP pilot plant for risk mitigation

Multifunctional technology transfer and absorption core team

Virtual Tour

 

Contact Us

Country
CAPTCHA This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
resourceMainImage

JUNE 28, 2022

Neoantigen Specific T cells For Cancer Immunotherapy

Neoantigen specific T cells for cellular cancer immunotherapy An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence...

Read More
resourceMainImage

Building successful long-term partnerships with CDMOs from early drug discovery through commercialization

Building successful long-term partnerships with CDMOs from early drug discovery through commercialization Maximizing efficiency in drug research, development, and manufacturing is crucial for turning new innovations into therapeutic and financial benefits. Over the past couple of decades, pharmaceutical companies have increasingly turned to contr...

Read More
resourceMainImage

Technology meets sustainability - How a complex API development process goes green

We are always looking for ways to enhance the sustainability of our products and services. Our team successfully developed a scalable manufacturing process for the API product of one of our Biotech clients using eco-friendly manufacturing technologies. Read the case study to learn more. ...

Read More

Alternate end-game strategies towards Nirmatrelvir synthesis: Defining a continuous flow process for the preparation of an anti-COVID drug

2023

Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...

Read More
View All
×

You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.

If you wish to continue to this external website, click Proceed.

ProceedBack