How VLE Therapeutics and Biostór’s Strategic Partnership Can Streamline Your Cell Banking Needs

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In the field of cell banking, efficiency and reliability are essential. Biostór and VLE Therapeutics have established a strategic partnership to deliver an end-to-end (E2E) cell banking solution that addresses the specific needs of our clients with high standards of quality and compliance. This post outlines the detailed process of our collaboration, from initial consultation to final delivery, emphasizing the integration of our services.

Planning Phase

Step 1: Initial Consultation and Discovery Call

The process begins with a discovery call, a critical component of our Accelerated & Innovative Mobilization (AIM) process. Representatives from Biostór and VLE Therapeutics meet with the client in person or online to thoroughly understand their cell banking requirements. This discussion covers project scope, timelines, and any specific challenges. Early alignment allows us to customize our services to meet the client’s unique needs, ensuring an efficient transition from cell line development to the creation of Master and Working Cell Banks. 

Step 2: Technical Evaluation and GMP Compliance

Following the initial consultation, we conduct a comprehensive technical evaluation in accordance with Good Manufacturing Practice (GMP) standards in Europe. This phase includes: 

  • Process Review: Mapping all process stages to ensure complete understanding. 
  • Equipment and Facility Validation: Verifying that we meet necessary specifications. 
  • Documentation Review: Ensuring all documentation aligns with GMP requirements. 
  • Regulatory Compliance: Adhering to EU GMP guidelines and ICH Q5D guidelines specific to cell banking activities. 
  • Quality Compliance: Ensuring all quality requirements are met across the entire process. 

Step 3: CMC Planning Phase

Next, we implement the Chemistry, Manufacturing, and Controls (CMC) planning phase to support the client’s drug development: 

  • Chemistry Assessment: Evaluating the molecular structure, biological activity, and stability of the product. 
  • Manufacturing Process: Developing, scaling up, and validating the manufacturing process, defining control strategies, and ensuring the quality of raw materials and final products. 
  • Control Specifications: Establishing specifications for the product and its intermediates and setting up quality control testing methods. 
  • Documentation: Preparing detailed documentation in accordance with quality standards and regulatory requirements. 
  • Regulatory Strategy: Creating a regulatory strategy aligned with guidelines from bodies such as the FDA or EMA and supporting preparation for submissions like INDs. 
  • Quality Management System (QMS): Implementing QMS principles to guide the product lifecycle. 
  • Risk Management: Identifying and controlling potential risks throughout the CMC process to ensure product safety and efficacy. 

Step 4: Proposal Development

After the technical evaluation and CMC planning, we develop a comprehensive proposal for the client. This proposal documents all aspects of the client’s needs, including data from the initial stages, cost estimation, project timelines, and management plans. This step formalizes the strategic partnership and accelerates project timelines. 

Action Phase 

Step 5: Import and Shipping by Biostór

Biostór manages all shipping arrangements from global sites, ensuring the safe and compliant transfer of cell banks. Our logistics team uses validated shipping containers equipped with GPS tracking and temperature monitoring to maintain the required conditions during transit. Clients have 24/7 access to a dedicated portal to verify the real-time status of shipments, providing transparency and peace of mind. This system ensures that cell banks are transported securely and arrive in optimal condition for further processing. 

Step 6: Storage at Biostór

Biostór offers secure storage solutions tailored to meet specific cell banking requirements. Our facilities are equipped with advanced monitoring systems to maintain optimal conditions, such as controlled temperature and humidity levels, ensuring the integrity of cell banks. Biostór’s storage services also include detailed inventory management, with real-time tracking and access to cell bank status through our client portal.  

Step 7: Transfer to VLE Therapeutics for Manufacturing

Biostór manages the logistics for transferring materials to VLE Therapeutics for cell bank manufacturing. This process involves meticulous planning to maintain the integrity of samples during transit. Biostór coordinates with VLE to schedule shipments, ensuring timely delivery to avoid any delays in the manufacturing process. Our seamless logistics support includes all necessary documentation and compliance with international shipping regulations. Furthermore, we handle the retrieval and transfer of individual vials from the working cell bank to various sites as needed, adhering to strict Standard Operating Procedures (SOPs) for consistency and compliance. 

Step 8: Cell Banking Manufacturing by VLE Therapeutics

VLE Therapeutics undertakes the cell banking manufacturing process using state-of-the-art technologies and facilities. This phase includes cell line expansion, cryopreservation, and the creation of Master and Working Cell Banks. VLE’s manufacturing process adheres to stringent GMP standards, ensuring high-quality and compliant cell banks. 

Each batch undergoes rigorous quality control tests, including viability assays, sterility tests, and genetic stability assessments. Detailed records are maintained for traceability and regulatory compliance. VLE’s expertise in cell bank manufacturing ensures that the final product meets the specific needs and quality standards required by the client. 

Step 9: Return to Biostór for Storage or Distribution

Upon completion of the manufacturing process, the cell banks are transported back to Biostór for long-term storage or distribution to clients and third parties. Our end-to-end distribution services ensure that cell banks are delivered in optimal condition, ready for immediate use in research or clinical applications.  

The partnership between VLE Therapeutics and Biostór provides a comprehensive E2E solution for cell banking, combining VLE’s expertise in development and manufacturing with Biostór’s capabilities in transportation, storage, and distribution. This integrated approach ensures that clients’ needs are met with the highest standards of quality and compliance.