Vaccines & Biologics Consulting From Lab to Launch—Guiding Innovation in Complex Biologics

At OriPeutic BioServices, we understand what it takes to bring groundbreaking vaccines and biologics to patients. From early development to regulatory approval and commercial readiness, we help you optimize your processes, systems, and teams to achieve scientific and operational success.

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Integrated Solutions for Complex Challenges

Whether you're developing novel mRNA platforms, cell-based therapies, or traditional biologics, our consultants bring deep scientific knowledge, hands-on industry experience, and cross-functional capabilities to solve your most pressing challenges.

We don’t offer one-size-fits-all answers. Instead, we provide custom, practical solutions designed to meet technical, organizational, and regulatory needs—while ensuring your internal teams are equipped to sustain success long after our engagement ends.

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Our Vaccines & Biologics Expertise

Technical & Operational Services

• Process development and optimization (upstream & downstream)

• Analytical method development and validation

• Facility design and startup

• Equipment qualification and tech transfer strategy

• Quality by Design (QbD), PAT, and process characterization

Regulatory & Quality Services

• Regulatory strategy and filing (IND, BLA, EU CTAs/MAA)

• cGMP and GxP compliance support

• Quality systems design and inspection readiness

• Product lifecycle planning and post-market compliance

• Risk management and deviation/CAPA oversight

Organizational Integration

• Interim leadership and cross-functional team alignment

• Change management and workforce readiness

• Coaching and mentoring for operational and quality teams

• Knowledge transfer to ensure long-term continuity and control

Real Support. Real Results.

Our consultants embed directly into your team—from boardroom strategy to lab floor execution. We’re known for building trust, driving performance, and guiding teams through complex biologics programs with clarity and confidence.

 

 

Who We Support

We work with companies in:

• Vaccines (viral vector, mRNA, subunit, and inactivated platforms)

• Biologics (monoclonal antibodies, biosimilars, fusion proteins)

• Advanced therapies (cell & gene therapies, immunotherapies)

• CDMOs, biotech startups, and global pharma innovators

The OriPeutic Difference

• Deep, hands-on expertise across development, quality, and manufacturing

• Experience with global regulatory authorities (FDA, EMA, WHO)

• Integrated project management and execution capabilities

• Focus on sustainable implementation and team capability building