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Welcome
to Bench2Batch

Bench2Batch™ provides expert CMC and process validation support across the product lifecycle —
from tech transfer and characterization to PPQ, CPV, and APQR.

Bench2Batch™ provides end-to-end CMC, MSAT, and validation expertise to help biopharmaceutical companies scale confidently from development to commercial manufacturing. Our services are grounded in science, risk-based thinking, and regulatory expectations—delivered by experienced practitioners who have executed these activities at scale.

What We Do
( OUR SOLUTION)

End-to-end Phase appropriate CMC support

WHY BENCH2BATCH™

Bench2Batch is led by Naveenganesh Muralidharan,

Biopharmaceutical leader with 20+ years of experience in GMP manufacturing, tech transfer, and end-to-end process validation across biologics, gene therapy, oligonucleotides, and RNA modalities. Proven in advancing programs from early development through commercial launch, leading MSAT, CQV, and process scale-up with strong FDA/EMA compliance. Extensive expertise in Upstream, Downstream, batch record authoring/review, data trending, deviation and change control, and on-site CMO campaign support. Recognized for first-time-right execution, cross-functional leadership, and driving robust supply chains and secondary vendor transfers to ensure reliable global manufacturing.

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

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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

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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