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Transforming Complex Biopharma Processes In to Clear, Compliant CMC Documentation

Bench2Batch™ helps biopharmaceutical teams move confidently from development to GMP manufacturing with science-based, audit-ready documentation and robust process understanding.

THE PROBLEM WE SOLVE

Biopharma teams often struggle with:

  • Incomplete or unclear CMC documentation

  • Gaps in process understanding during scale-up

  • Delays in tech transfer or PPQ readiness

  • Inconsistent approaches to CPV and annual product review

  • Lack of engineering-based modeling for critical steps


These challenges increase regulatory risk, slow timelines, and create unnecessary rework.

What We Do ( OUR SOLUTION)

End-to-end Phase appropriate CMC support

We specialize in:

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  • Tech Transfer Packages & Protocols

  • Process Characterization (DOE-driven)

  • Process Validation (PPQ) Strategy & Documentation

  • Continued Process Verification (CPV) Frameworks

  • Annual Product Quality Review (APQR) Documents

  • Risk Assessments (FMEA, Control Strategy, Design Space).

  • Modalities: Oligonucleotide, mAb, AAV & Viral Vector CMC documentation

 

Every document is structured, compliant, and scientifically justified.

WHY BENCH2BATCH™

Bench2Batch is led by Naveenganesh Muralidharan, a 20-year biopharmaceutical MSAT expert who has:

  • Supported programs from development → launch

  • Designed scale-up models from 250 mL → 20,000 L bioreactors

  • Created online scale-down models, shear assessments, CFD simulations

  • Built DOE-based characterization protocols for biologics & oligonucleotides

  • Authored 25+ publications in Bioprocess International and American Pharmaceutical Review on Biopharma CMC activities

  • Led successful tech transfers across biotechnology platforms

  • Developed digital tools using Python, JavaScript, Retool, and advanced analytics

  • ​

You get more than documentation — you get a true technical partner.

Naveenganesh Muralidharan

Founder & Principal Consultant

  • LinkedIn

On-Line Bioreactor Scale-Up & Scale Down Tools

These online bioreactor calculators simplify the process of scaling up or down between bench and production scale. They offer tools to predict pCO2, assess shear from impellers and sparging, and

calculate OTR and KLa. This helps users optimize process conditions and improve scalability

across different reactor sizes.

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On-line Engineering and Applied statistics tools in Process Validation

Comprehensive biopharma process validation suite featuring microbial limits, endotoxin modeling, mixing risk, PPQ run justification, OC curve sampling, and CI/TI/Ppk acceptance tools.

Note: These online applications represent limited-scope demo versions. Bench2Batch delivers deeper, fully customized, and regulatory-aligned process validation solutions. Contact us to learn more

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Technical Insights

TESTIMONIALS

Mark Davis, Director MSAT @ AGC Biologics, CO USA

“Naveen is one of the most capable engineers I have worked with. His ability to understand complex scientific and statistical ideas stands above most bioprocess professionals. He understands upstream, harvest, and CIP/SIP operations at practical and theoretical levels. On top of that, he understands regulatory needs for commercialization of bioprocess products. A fantastic asset for a large or small company with commercial aspirations.”
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