Batavia Biosciences’ Post

Nice question Batavia Biosciences! Perplexity answered similarly to ChatGPT. From Perplexity (With sources below): The decision between producing viral vectors in-house or outsourcing to a Contract Development and Manufacturing Organization (CDMO) involves several key considerations, each with its own set of advantages and disadvantages. In-House Production **Advantages:** 1. **Control**:   - In-house production provides complete control over the manufacturing process, it enables direct oversight of quality control and compliance with Good Manufacturing Practices (GMP), which can be crucial for maintaining high standards[2]. 2. **Speed**: 3. **Customization**:   - Tailoring the production process to specific needs is easier when the process is managed internally. This is particularly important for highly specialized or bespoke therapies[2]. **Disadvantages:** 1. **High Initial Investment**:   - Setting up in-house manufacturing requires significant capital investment in facilities, equipment, and skilled personnel[4].   - The costs associated with building and maintaining GMP-compliant facilities can be prohibitive, especially for smaller companies[2]. 2. **Resource Intensive**:   - Managing in-house production demands substantial resources, including hiring and training specialized staff, which can be challenging for smaller organizations[2]. CDMO Production **Advantages:** 1. **Expertise and Experience**: CDMOs bring extensive experience in viral vector production, often having optimized processes and advanced technologies that can enhance efficiency and yield[1][3]. 2. **Scalability**:  CDMOs are equipped to handle scale-up from research to clinical and commercial production, which can be a complex and resource-intensive process[1][3]. 3. **Risk Mitigation**: Outsourcing to a CDMO can de-risk the project by leveraging their established processes and regulatory expertise, potentially avoiding costly delays and pitfalls[1]. **Disadvantages:** 1. **Less Control**: Dependence on a CDMO can introduce risks related to scheduling and capacity constraints, potentially causing delays[4]. 2. **Long-Term Costs**:   - While initial costs may be lower, long-term contracts with CDMOs can be expensive, and changes in project scope or requirements can incur additional fees[3]. Citations: [1] https://lnkd.in/g6Yu2qQZ [2] https://lnkd.in/guxJtuF9 [3] https://lnkd.in/gNK3stFE [4] https://lnkd.in/g4ZawveR [5] https://lnkd.in/gWmu_BHg

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The hurdles we face when trying to develop eco-friendly products for the laboratory is often an opportunity for innovation. This article has a similar opinion when it comes to regulatory. Currently there are thousands of biosimilars in the pipeline, when the guidelines were released during a time there were merely a hundred or so. "There is opportunity to use machine learning based approaches to strengthen the body of conclusions on biologic drugs and therefore use it to drive regulatory strategy." #ai #regulatory #bioprocessing https://hubs.ly/Q02f2Gr_0