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In biologics outsourcing, finding the right CDMO can feel like the Goldilocks dilemma — too few or too many options can be equally challenging. Just as Goldilocks sought what was "just right," antibody developers must balance capabilities and contracts to find the ideal CDMO for their needs.
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While the U.S. government works to pass the BIOSECURE Act, which aims to protect the IP of U.S. pharma companies, the EU is simultaneously seeking to increase innovation across the European biomanufacturing industry. Amid these cultural shifts, sponsors are considering the best global partnerships for their goals.
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The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development. Mabion offers drug-tolerant methods for evaluating immunogenicity, and proper assessment is crucial for demonstrating clinical similarity.
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Transparency and communication are essential to the success of a manufacturing partnership. If a CDMO is unwilling to have frank conversations during the proposal phase, that is likely a red flag. The right partner’s team will help you make educated choices while ensuring quality, reasonable costs, and timeline efficiency.
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Tech Transfer for biologic medicinal products is complex — filled with potential pitfalls, hazards, and breakpoints. Precision manufacturing must be coupled with speed to optimize processes and minimize risk. Review strategies and methodologies for seamless technology transfer to your CDMO through the lens of real-world case studies.
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