What We Can Do
At Lykan, we take a comprehensive approach to technology transfer that begins with a detailed assessment of our partners’ manufacturing processes, testing requirements, and development stage.
By evaluating the steps needed to efficiently implement cGMP production, we work to identify opportunities to optimize processes as they move toward commercialization. This multidisciplinary assessment by experts in cell therapy manufacturing provides a thorough project plan to meet our partners’ timelines. We support our partners by:
- Transfer of partner or Lykan PD processes to Manufacturing Science & Technology (MS&T) for clinical/commercial manufacturing
- Process optimization as identified by a gap assessment for scale-up and closed system requirements
- Confirmation of Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) at full scale in both a non-GMP and GMP environment using training and engineering campaigns
- Establishment of process data tracking and trending
- Creation and refinement of all process documents including Master Batch Records (MBRs) and other supporting documents
- Execution of process validation and Aseptic process validation gating to clinical manufacturing
Seamless Transition Among Teams
- The MS&T team occupies a pivotal position between the partner and/or process development (PD), and the manufacturing team.
- MS&T, during the early tech transfer process, becomes the partner-process subject matter experts (SMEs) through close partner collaboration and historical cell therapy expertise.
- The MS&T team collaborates closely with the partner to ensure smooth technology transfer and the identification of process optimization needs such as scalability and the closing of unit operations.
Standardization and Training
MS&T develops and refines all process-related documents including Standard Operating Procedures (SOPs) and MBRs. Risk assessments, Process Verifications and Aseptic Process Verifications are all spearheaded by the MS&T team prior to initiation of cGMP manufacturing.
Lykan’s team has decades of biotechnology industry experience with different platforms, cell types, tools and technologies from both a product development approach but also from a manufacturing approach with multiple years of experience in the cell therapy CDMO industry.
Lykan has dedicated 1,100 sq. ft. of laboratory spaces available for technology transfer. Three laboratories are dedicated to our MS&T team, for the performance of technology transfer and for training our manufacturing team.
Interested in Cell Therapy CDMO Services?
Lykan Bioscience is a premier provider of development and manufacturing services