From Development to Delivery: How VLE Therapeutics and Biostór’s Strategic Alliance Streamline Cell Banking

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In cell banking, efficiency and reliability are essential. Biostór and VLE Therapeutics have established a strategic alliance 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.

Breaking down cell banking

Master and Working Cell Banks (MCB and WCB) are essential components in the biopharmaceutical industry, serving as the foundational material to produce biological products such as vaccines, cell-based therapies, and biologic drugs. At VLE Therapeutics, we recognize the critical role of cell bank management in supporting our clients’ endeavours. Cell banking is a pivotal service that involves the meticulous preservation of cell lines, which are vital for the ongoing advancement of biotechnology. It ensures the availability of a reliable and superior-quality supply of cells, which is indispensable for both research initiatives and the development of medical treatments. This service is integral to the progression of bringing new medicinal solutions from the laboratory to the marketplace, underpinning the innovation and success of our clients in the biotech sector. Through our strategic alliance with Biostór Ireland, we offer comprehensive solutions that span the entire spectrum from initial concept to full-scale manufacturing, thereby facilitating the seamless transition of Cell and Gene Therapy treatments from research labs to the global market.

Planning Phase

Initial Consultation and Discovery Call

The process begins with a discovery call, a critical component of our Accelerated Mobilization 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.

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 equipment and facilities 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

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

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 alliance and accelerates project timelines.

Action Phase

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.

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.

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 Therapeutics 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.

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 Therapeutics 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 Therapeutics' expertise in cell bank manufacturing ensures that the final product meets the specific needs and quality standards required by the client.

Cell Banking in Operation at VLE Therapeutics

Master Cell Bank (MCB), a collection of cells that originate from a single cell clone, which is expanded and stored under defined conditions. It serves as the primary source of cells for all subsequent manufacturing processes

The manufacturing process involves selecting and expanding either human, insect, or mammalian cell lines, which could include primary cells, stem cells, or established cell lines. The cells are then divided into aliquots, dispensed into containers like vials or bags, and cryogenically frozen using liquid nitrogen to maintain viability over long periods

The main function of an MCB is to produce a sufficient number of viable cells to establish WCBs. It is characterized and tested to ensure the absence of contamination and the maintenance of cell line integrity

Working Cell Bank (WCB), derived from the MCB under defined cell culture conditions and serves as a specialized repository for use in client processes. WCBs are tapped into for producing biological products, such as monoclonal antibodies or recombinant proteins, and undergo extensive authentication and quality control testing before expansion.

How our Supply Chain Centre of Excellence Supports

Material sourcing and management are critical components that ensure the success and efficiency of projects. Our Supply Chain Centre of Excellence (CoE) at VLE Therapeutics has developed a robust framework that streamlines these processes. Our approach involves a rigorous supplier qualification program, ensuring that all materials meet the highest quality standards and are sourced responsibly. Our CoE plays a pivotal role in this ecosystem, providing expert guidance and leveraging strategic partnerships with suppliers and a library of qualified materials to optimize the supply chain and support client needs. This synergy accelerates project mobilisation, enabling rapid response to the evolving needs of cell banking and ensuring that our clients can swiftly progress from concept to manufacturing with confidence in the quality and traceability of their materials. Material traceability is integral to our operations, supply chain maps are utilized to provide a visual representation of the supply chain of each material end to end to ensure transparency, quality, and compliance of each piece of materials used in our cell banking process.

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.

Coordination and Project Management

Within our alliance, coordination and project management are paramount. We blend structured mechanisms and agile methodologies to ensure alignment with clients' objectives and timelines.

• Efficient Coordination Mechanisms: Regular site visits, bi-weekly operational calls, and strategic workshops facilitate ongoing dialogue between VLE Therapeutics and Biostór teams, enabling us to stay abreast of project developments and address emerging challenges proactively

• Robust Project Management: We leverage project management tools like encrypted instant message applications, company portals, webinars, and seminars for real-time communication. This ensures effective exchange of information, progress tracking, and task coordination, upholding the highest standards of project management excellence. As we progress our relationship, we believe the use of our proprietary CMC platform iAchieve (TM) will add huge value to our clients.

• Quality Assurance and Compliance: Quality assurance and compliance are integral to our alliance. Through joint efforts, we uphold the integrity and reliability of our cell banking solutions, providing clients with peace of mind and confidence.

• Adherence to Regulatory Standards: Both VLE Therapeutics and Biostór maintain rigorous adherence to Good Manufacturing Practice (GMP) guidelines, European Union (EU) GMP regulations, and other relevant frameworks. This commitment forms the cornerstone of our quality management approach.

• Comprehensive Quality Control: We conduct thorough quality control tests and audits, scrutinizing every aspect of our operations. Service level agreements, internal audits, and in-house regulatory personnel further reinforce our commitment to quality assurance.

• Proactive Risk Mitigation: Through regular communication and ongoing risk assessments, we anticipate and mitigate obstacles during the cell banking process. Weekly communication sessions serve as valuable forums for discussing challenges and pooling collective expertise.

• Effective Problem-Solving Tools: Root cause analysis, scenario planning, and contingency planning are strategic approaches we utilize to identify and resolve issues. Comprehensive protocols and procedures are in place to address unexpected events and emergencies.

• Continuous Improvement and Innovation: Continuous improvement and innovation drive our relationship. We prioritize the pursuit of innovation across all facets of our operations, from optimizing manufacturing processes to enhancing logistics management.

• Client Feedback Integration: Actively seeking input from clients and stakeholders guides our efforts to develop tailored solutions. Through a relentless commitment to continuous improvement and innovation, we drive positive change in cell banking.

The Benefits of Outsourcing Cell Banking: Why Work with VLE Therapeutics and Biostór?

VLE Therapeutics and Biostór prioritize transparency and accountability in all operations, fostering open communication and collaboration with clients to address potential risks proactively. Our teams conduct regular audits and inspections, both internally and externally, to identify areas for improvement and ensure alignment with regulatory standards. By implementing contingency plans and disaster recovery measures, we minimize disruptions and maintain business continuity, providing clients with peace of mind and confidence in the reliability of our services.

Excellence in Cell banking is ingrained in our DNA. Our unwavering commitment to quality and compliance drives every aspect of our cell banking processes. We adhere rigorously to international standards, including the ICH Q5D guidelines, ensuring the derivation and characterization of cell substrates meet the highest benchmarks. Our meticulous approach guarantees that each cell bank we manage maintains the principles of identity, purity, and stability. Through robust quality control testing and a comprehensive management system, we uphold the integrity and efficacy of our clients’ cell banks, assuring compliance with global standards

Our teams comprise industry-leading experts with extensive experience in cell banking, ensuring clients receive top-tier proficiency and insight. Equipped with advanced facilities and infrastructure, including state-of-the-art laboratories and secure storage facilities, we offer a secure environment for cell banking activities, safeguarding the integrity of biological materials.

Partnering with VLE Therapeutics and Biostór provides clients with a comprehensive suite of services, including cell bank development, manufacturing, transportation, and storage. This integrated approach streamlines operations and minimizes complexity, offering a single solution for all cell banking needs. From consultation to delivery, our approach ensures precision and exceptional quality. By leveraging expertise in development, manufacturing, transportation, storage, and distribution, we provide clients with seamless experiences that accelerate their journey from discovery to market.

Looking to the Future of Cell Banking

The horizon of cell banking is expanding rapidly, especially in the realm of cell and gene therapy, where it is becoming increasingly pivotal. VLE Therapeutics and Biostór are at the forefront of this evolution, providing cutting-edge support for the burgeoning needs of the industry. As we advance, VLE Therapeutics and Biostór will continue to invest in innovative technologies and infrastructures, such as the VLE Therapeutics ‘factory of the future’, to streamline the development and manufacturing processes for cell and gene therapies. Our commitment to excellence positions us to offer comprehensive solutions that cover the entire lifecycle of cell banking—from concept to commercialization. By doing so, VLE Therapeutics and  Biostór Ireland, not only contribute to the advancement of cell banking but also ensure that our clients are well-equipped to meet the future demands of personalized medicine and transformative healthcare solutions.

Finally, we are excited to announce an upcoming webinar on 17 October where you’ll get to explore the benefits of outsourcing with VLE Therapeutics and Biostór and discover how our strategic alliance can empower you to achieve your research and development goals with confidence and success.