Supporting Pharmaceutical Innovation with Technology Transfer
Callidus Research Laboratories, your dedicated partner in pharmaceutical drug product development and innovating groundbreaking technologies is conscious of the importance of technology transfer in the success of any product. Our expertise lies in transferring technology and knowledge to our clients, empowering them to efficiently manufacture their drugs.
Callidus believes that successful technology transfer is critical to project success and so it ensures the systematic transfer of scientific information, formulation process, analytical methods and the technological basis associated with a drug product from its development site (knowledge center) to the receiving side (manufacturing plant) implying a positive experience learned and realized by both sides by complying all the regulatory requirements in terms of Efficacy, Quality and Safety.
Callidus Research Labs takes pride in supporting its customers by offering end-to-end support, the formulation and analytical scientists from Callidus are present at the manufacturing site for seamless execution of analytical method transfer, scale up and dossier submission batch manufacturing. As a preventive measure, analytical scientists can also be present during each analysis of submission batch samples on a need basis in order to ensure that there are no issues during stability analysis so as to prevent any delays in dossier filing.
Key Steps in the Technology Transfer Process
Preliminary Tech Transfer Dossier Preparation- We kickstart the process by meticulously preparing pre- tech documentation, encompassing manufacturing guidelines, specifications, standard testing procedures (STPs), transfer protocols, stability, and sampling protocols. This comprehensive dossier is then handed over to the manufacturing site, laying the groundwork for successful technology transfer.
Procurement Phase- Ensuring a smooth procurement phase is crucial for the tech transfer process. Callidus takes charge of procuring and receiving raw materials (RMs) and packaging change parts, as well as columns and reagents required for scale-up and process validation batches at the manufacturing site.
Site Transfer Phase- During this phase, we conduct a thorough review of all Contract Manufacturing Organization (CMO) documents to ensure compliance with product quality and regulatory requirements. Our meticulous approach helps in aligning all aspects with the highest industry standards.
Finished Product Method Transfer, Scale-Up Batch Manufacturing and Report Finalization- We facilitate the execution of finished product method transfer, and scale-up batches at the manufacturing site and assist in the preparation and review of the scale-up summary report. This ensures that the production process adheres to predefined protocols and produces consistent results.
Process Validation Phase- Ensuring the preparation of validation batch documentation at the manufacturing site is a critical step in the technology transfer process. Callidus actively reviews validation batch documents, provides necessary assistance, and oversees the execution of validation batches as per the defined protocols.
Evaluation of Stability Reports- As part of our commitment to seamless technology transfer, our analytical scientists may be present during the stability analysis of dossier submission batches at various time points. This enables us to verify and maintain the integrity of the transferred technology throughout the stability evaluation process.
Technology Transfer Approach
Callidus employs a comprehensive approach to technology transfer that takes into account several crucial factors:
Identifying Appropriate Technology and Equipment- We thoroughly assess the existing technology and equipment at the client’s manufacturing site while identifying any additional equipment or processes required for specific drug manufacturing. This enables us to create a tailored technology transfer plan for each client.
Establishing a Detailed Process Flow Diagram- A clear and detailed process flow diagram is fundamental for understanding the drug manufacturing process and ensuring consistent production of drugs to meet quality standards. Callidus collaborates with clients to develop a robust process flow diagram that guides the entire technology transfer process.
Developing Process Control Strategies and Analytical Methods- Process control techniques and analytical methodologies are critical for obtaining the target medication quality and ensuring consistency in the manufacturing process. Callidus collaborates extensively with clients to develop these strategies and approaches prior to technology transfer.
Training Personnel- We give full training to client staff, familiarizing them with the production process as well as any new equipment or technology being transferred. This guarantees that the client's facility runs smoothly and efficiently.
Providing Documentation- For successful technology transfer, detailed documentation, such as process flow diagrams, standard operating procedures (SOPs), and training materials, is required. Callidus guarantees that the required paperwork is supplied to the customer, promoting the use of standard operating procedures.
Validating the Process- Process Validation is an important stage in verifying the manufacturing process's capacity to reliably generate pharmaceuticals that fulfil the needed quality requirements. To validate the technology transfer process, Callidus undertakes extensive process qualification and validation studies.
Start Your Technology Transfer Journey with Callidus Labs
At Callidus Labs, we take pride in our well-planned and implemented technology transfer procedure, which enables our pharmaceutical clients to produce their products effectively and consistently. We ensure that our clients' aims of bringing novel pharmaceuticals to market are met by a team of competent scientists and a holistic strategy. Please contact us right away to begin a smooth and effective technology transfer for your pharmaceutical goods.
At Callidus, we don't just facilitate technology transfer; we empower transformations. Our commitment to excellence, innovation, and collaboration propels us to redefine the landscape of pharmaceutical technology transfer. Join us on this exhilarating journey as we craft a future where ideas seamlessly evolve into solutions that touch lives across the globe.
