Gene therapy is a challenging, constantly evolving field. The use of viral vector therapies has opened new doors for research and potential applications.
However, conducting gene therapy research is also a time-consuming and delicate process. It's essential to have easy access to aseptic filled viral vectors. BioStem Life Sciences offers aseptic filling for viral vector therapies and has experience in manufacturing biotherapeutics for gene therapies and cell therapeutics.
The difference between sterile and aseptic processing is small but critical. Both processes' goal is to eliminate harmful microorganisms. However, the aseptic process results in a contamination-free environment rather than a sterile one.¹
The sterile process eliminates all germs. This process is essential for clean rooms, but not useful for storing viral vectors or cell cultures. Instead, BioStem Life Sciences uses aseptic fill and finish, which removes harmful microorganisms, while leaving the target viral vector or cell culture intact. Aseptic filling also stops the bacteria or virus from reproducing.
Innovations in aseptic filling have allowed researchers to use viral vectors in gene therapies. Viruses replicate by introducing their genetic material into their host cell. This genetic material overrides the host cell's normal function and it will start creating more virus cells. Usually, the body eventually destroys the virus cells, either on its own or with medication.²
However, some viruses inject their genes into the host cell's genome. These genes remain a part of the cell until it dies. These viral vectors can be altered and used to deliver healthy cells in a targeted manner.
To create a viral vector, a scientist will remove the harmful parts of the virus and replace it with new genes. However, encoding the optimal viral vector is a delicate and challenging process that usually requires a research facility experienced in aseptic filling.
There are two categories of viral vectors that encompass the five classes determined by their genomes' actions.³ Lentiviruses and oncoretroviruses have genomes that integrate into the host's chromatin. Adenoviruses, adeno-associated viruses, and herpes viruses remain as extrachromosomal episomes within the cell's nucleus.
In recent years, clinical studies have found viral vectors effective in treating many disorders, including metabolic, cardiovascular, muscular, hematologic, ophthalmologic, some infectious diseases, and some cancers.⁴ However, the ability of labs to make enough viral vectors limits research.
Each viral vector is unique and requires extensive research. This process can be lengthy, sometimes causing a backup in supplies.⁵
Before making the viral vector, you need to choose a system. The type of system depends on many factors.⁶ These include tissue tropism, whether you require in vivo or ex vivo process; integrated or non-integrated modification, if the target cell is replicating or non-replicating; prior immune exposure and the safety of the patient.
The manufacturing process involves several phases before a completed viral vector is ready for gene therapy application. First, the company manufactures the materials needed to make the viral vector, including plasmids and cell lines. Next, it makes the infectious viral vector from the new materials. Finally, the company harvests the product and stores it using aseptic filling.⁷
Scientists and researchers must find a reliable company to produce their viral vectors. Since the process is complicated and dependent on your preferred viral vector, researchers need to trust that their manufacturer is knowledgeable in aseptic filling and viral vector manufacturing.
BioStem Life Sciences is an experienced biopharmaceutical company that prides itself on its quality control. We monitor the environment and personnel and always perform a full visual inspection before and after filling. The BioStem Life Sciences team conducts a final seal-integrity test to ensure that your product remains uncontaminated.
The validated aseptic fill and finish processes are available for an entire production campaign or a smaller single project and are customizable. You can choose between multiple vial and bag lot sizes and can request various sterilization options.
If you need aseptic filling for viral vector therapies, contact BioStem Life Sciences. Our team is also happy to answer any questions you might have about their process or new technologies or developments in the field. BioStem Life Sciences is here to help your gene therapy trials succeed. Call us today at (954) 380-8342.
(1) Ankur Choudhary. “Difference Between Aseptic and Sterile Conditions.” Pharmaceutical Guidelines. Pharmaceutical Guidelines. Accessed September 25, 2020. https://www.pharmaguideline.com/2017/10/difference-between-aseptic-and-sterile-area.html
(2) “Viral Vectors.” Gene Therapy Viral Vectors Explained. GeneTherapy.net. Accessed September 25, 2020. http://www.genetherapynet.com/viral-vectors.html
(3) Dr. Tomislav Meštrović. “What Are Viral Vectors?” News Medical Life Sciences. News Medical Life Sciences, August 23, 2018. https://www.news-medical.net/life-sciences/What-are-Viral-Vectors.aspx
(4) Kenneth Lundstrom. “Viral Vectors in Gene Therapy.” Diseases (Basel, Switzerland). MDPI, May 21, 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6023384/
(5) D Bouard, N Alazard-Dany, and F-L Cosset. “Viral Vectors: from Virology to Transgene Expression.” British Journal of Pharmacology 157, no. 2 (2009): 153–65. https://doi.org/10.1038/bjp.2008.349
(6) Steve Pettit, Clive Glover, Joseph V. Hughes, John Madsen, and Pratik Jaluria. “Upstream Manufacturing of Gene Therapy Viral Vectors.” Cell Culture Dish, October 4, 2018. https://cellculturedish.com/upstream-manufacturing-gene-therapy-viral-vectors
(7) Pettit, “Upstream Manufacturing.”
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