Frequently Asked Questions
Welcome to the Flash BioSolutions FAQ page. Here, you will find comprehensive answers to the most commonly asked questions about our advanced therapeutic services, cutting-edge technologies, and seamless production processes.
Our goal is to provide clear and detailed information to help you understand how we can support your research or clinical development and GMP manufacturing needs. If you have any additional questions or require further assistance, please do not hesitate to contact our team of experts. We are dedicated to providing prompt and thorough responses to ensure your complete satisfaction.
FAQ – GENERAL QUESTIONS
Explore our media section to discover insightful videos, informative podcasts, and engaging articles showcasing the innovative applications and advancements in cell testing technology.
How do Flash BioSolutions lentiviral vectors differ to those from other providers?
Flash BioSolutions has developed a proprietary purification & concentration process for lentiviral vectors production. Purification levels are tailored to your application.
Flash BioSolutions generates high titer and highly pure lentiviral particles that guarantee high cell viability and maintaining the phenotype of your cells. Our technical experts are dedicated to the success of your project, from cassette design to transduction protocols.
What are the differences between AAV and Lentiviral vectors?
Each method has both advantages and drawbacks for specific applications, depending on its technical characteristics. For example, the use of AAVs for the transfer of genetic material is limited by the length of the sequence of interest and by the pseudotype; non-viral methods can be problematic for the study of gene expression in primary cells because of cell toxicity and/or lower efficiency.
FAQ – GMP Viral Vectors
What are the production times for GMP viral vectors?
Your needs, your deadlines! If your construct fits directly into our platform processes, the we can supply your GMP batch within 6 months. If your project requires several adjustments and special requests, the lead time can be longer, up to 12 months.
How is the quality and safety of viral vectors guaranteed?
With two decades of expertise, Flash BioSolutions has perfected a robust production and purification process, consistently delivering top-tier vector quality. What sets us apart? Our analyses, which form an integral part of our quality control plan, guarantee the production of batches that are strictly cGMP compliant and meet the requirements of regulatory agencies.
How does Regulatory Support work and what are the crucial steps in GMP production?
Our Project Manager and Quality Director will guide you through the FDA/EMA requirements and offer regulatory advice on test selection for GMP QC and stability studies. You’ll receive all the documentation you need to gain approval/authorization and take your next breakthrough therapy through to the first clinical trial, and beyond.