Biologics & Advanced Therapies (Cell & Gene)

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Navigating complex pathways for biologics (BLA, biosimilars), cell & gene therapies (rare diseases, expedited programs like Breakthrough/PRIME/Orphan/RMAT), vector design, CMC, immunogenicity, long-term follow-up, and HCT/P compliance (FDA 21 CFR 1271, AATB). Expertise extends to cell-based vaccines and immunotherapies.

Biologics present unique regulatory challenges due to their complex manufacturing processes and safety profiles. Regal Intel offers:

• BLA Submissions: Guiding manufacturers through the BLA process.
• Biosimilar Development and Approval: Navigating the regulatory pathway for biosimilars.
• CMC Strategy and Development: Ensuring robust manufacturing and control processes.
• Preclinical and Clinical Development: Assisting with preclinical and clinical trial design.
• Global Regulatory Strategies: Tailoring strategies for international markets.

Manufacturing biologics requires stringent quality control measures to ensure product safety and efficacy. Regal Intel assists with:

• cGMP Compliance: Ensuring manufacturing processes meet cGMP requirements.
• Process Validation and Optimization: Validating and optimizing manufacturing processes.
• Analytical Method Development and Validation: Ensuring accurate quality control testing.
• Stability Studies and Shelf-Life Determination: Addressing the unique stability challenges of biologics.

Clinical trials for biologics require specialized expertise in immunology, pharmacology, and safety monitoring. Regal Intel offers:

• Clinical Trial Design and Protocol Development: Incorporating unique aspects of biologics.
• Immunogenicity Assessment: Assessing the immunogenic potential of biologics.
• Pharmacovigilance and Safety Monitoring: Ensuring patient safety throughout clinical trials.
• Data Management and Statistical Analysis: Handling complex data from biologics trials.

Maintaining ongoing safety and efficacy monitoring is crucial for biologics. Regal Intel provides:

• Pharmacovigilance System Development: Tailored to the unique needs of biologics.
• Risk Management Plans: Developing and implementing strategies to mitigate risks.
• Post-Market Clinical Follow-up Studies: Ensuring long-term safety and efficacy.