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BLOG Viral Vectors and gene therapy basics summarized

Viral Vector and gene therapy basics summarized

...report: Glybera. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002145/WC500135476.pdf. [11] Zolgensma https://www.fda.gov/media/126109/download [12] Luxturna https://www.fda.gov/media/109906/download [13] https://www.prnewswire.com/news-releases/adeno-associated-virus-aav-vector-based-gene-therapy-market-expected-to-grow-at-a-significant-cagr-of-43-4-during-the-study-period-2019-30–301213850.html [14] https://www.ema.europa.eu/en/medicines/human/referrals/zynteglo [15] Liu J, Seol DW. Helper virus-free gutless adenovirus (HF-GLAd): a new platform for gene therapy. BMB...

Beginner’s guide to the production of AAV vectors for gene therapy – Mentored by a CDMO

...Granted FDA Fast Track Designation for GT005, an Investigational Gene Therapy for Dry Age-Related Macular Degeneration.https://www.businesswire.com/news/home/20200921005923/en/Gyroscope-Therapeutics-Granted-FDA-Fast-Track-Designation-for-GT005-an-Investigational-Gene-Therapy-for-Dry-Age-Related-Macular-Degeneration%22 [10] Adeno-associated Virus Serotypes: Vector Toolkit for Human Gene Therapy. https://www.cell.com/molecular-therapy-family/molecular-therapy/fulltext/S1525-0016(06)00204-8?_returnURL=https%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1525001606002048%3Fshowall%3Dtrue [11] In vivo...
Viral Vector production services at Biovian

Viral Vector Production

...(sterility, bioburden, endotoxin etc.) QP certification and full GMP documentation Viral vector GMP production facility The state-of-the-art production facility allows for flexible viral vector production scenarios. The cleanroom class C...
Biovian receives excellent NPS score

Biovian received a high Net Promoter Score, 72 in the 2020 client satisfaction survey

...[1] Net Promoter Score Definition. https://www.medallia.com/net-promoter-score/#:~:text=The%20Net%20Promoter%20Score%20is,customer’s%20loyalty%20to%20the%20brand. [2] What Do Companies with High Net Promoter Score Have in Common? https://www.retently.com/blog/companies-high-nps/ [3] What is Net Promoter Score®? Your introduction to NPS. https://www.hotjar.com/net-promoter-score/#:~:text=Net%20Promoter%20Score%20(NPS)%20is,to%20the%20story%20than%20that....
Antti Nieminen Biovian CEO

4 Areas where a CDMO can help your Viral Vector project.

...combined with Tangential Flow Filtration. Here we have an automated ÄKTA™ readyflux single-use TFF system for GMP manufacturing. Production-planning expertise together with state-of-the art-instruments makes for a winning combination. Johannes...
GMP-Grade Plasmid DNA Production

Plasmid DNA Production

...Control QC release testing QP Certification and full GMP documentation Plasmid Production Services – Flyer Download a Plasmid flyer Download Plasmid QC Test Package Example The QC tests for plasmids...
Microbial Production

Microbial Production

...assays Examples of compendial specification assays Appearance  pH Osmolality Sterility  Visible and subvisible particles  Clarity Colour Residual reagents Examples of microbiological QC and safety assays Sterility testing Bioburden (TAMC/TYMC) Endotoxin...
Aseptic Fill and Finish

Aseptic Fill and Finish Services

...various temperatures (RT, +4°C, -20°C, and -80°C) is provided on the same European Medicines Agency (EMA) certified site. Formulation Fill and Finish Visual inspection Labeling and packaging QP certification https://youtu.be/Gnel4c8-rvo...

Privacy Policy

Privacy Policy Biovian Oy is committed to protecting your privacy. We respect your rights as a data subject. This Privacy Policy when you use our website www.biovian.com or https://biovian.com/, or...
Adenovirus vector GMP manufacturing_blog

Adenovirus vector GMP manufacturing in adherent cell cultures and suspension cell cultures.

...adenovirus vector project, aiming for clinical trials.    References [1] Global Data  [2] China approves first gene therapy, Nat Biotechnol. 2004; 22(1): 3–4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7097065/  [3] Zabdeno https://www.ema.europa.eu/en/medicines/human/EPAR/zabdeno  [4] AZD1222 vaccine met primary efficacy endpoint in preventing COVID-19 https://www.astrazeneca.com/media-centre/press-releases/2020/azd1222hlr.html ...