Sabin inactivated polio vaccine upstream process development using fixed-bed bioreactor technology
Bibliographic record
Abstract
Eradication of polio disease remains a challenge for countries with limited health-care infrastructure. Regional vaccine production is expected to secure a sustainable and equitable availability of vaccines supporting the polio eradication end-game. Regional manufacturing of Inactivated Polio Vaccines based on the attenuated Sabin strains and using an isolator-based contained micro-facility is expected to avoid any potential risk of shortage of polio vaccines in the future, ensure equitable access to sufficient doses of IPV while securing a safe manufacturing environment. However, polio vaccine production requires biosafety level 3 containment and is complicated by the restrictions imposed from the adherent nature of the virus-producing Vero cell line. To overcome these issues that have hampered regional polio vaccine production so far, at Batavia Biosciences we developed an inactivated polio vaccine production process based on the polio Sabin strains in a contained microfacility. By incorporating a tangential flow filter coupled to a fixed-bed bioreactor with a large attachment surface area (150 m 2 ), we could increase process efficiency and reduce the production footprint allowing for regional demand-driven production. The reduced square meters of the manufacturing site that handles the live virus were achieved by integrating the fixed-bed bioreactor with the concentration step (TFF). The increased efficiency was realized by using less resources, fully disposable virus production, and a down- and up-scalable process depending on vaccine demand. The here-developed scalable production process with reduced production footprint is considered a useful and cost-effective method for regional vaccine production, for example in pandemic preparedness efforts to efficiently contain virus outbreaks. • Poliovirus vaccine production is feasible using a low-footprint container-sized production site. • Structured fixed-bed bioreactors enable linear upscaling of Vero cell growth and virus production. • A tangential flow filter coupled to a fixed-bed bioreactor increased process efficiency and reduced the production footprint. • The developed scalable production process is considered a useful and cost-effective method for regional vaccine production. • Regional isolator-based sIPV manufacturing is expected to ensure equitable access to sufficient doses of IPV.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".