top of page
  • White Facebook Icon
  • White Twitter Icon

.

CMC, MSAT, CQV Consulting:
 

  • Scale-Up & Tech Transfer: Risk assessments, Process Gap Assessments, and MPR generation

  • Process Characterization & Validation: PVMP, PPQ Protocols & Reports, and CPV execution

  • URS, FAT/SAT, IQ/OQ/PQ documents

What We Do ( OUR SOLUTION)

End-to-end Phase appropriate CMC support

We specialize in:

​

  • 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).

  • Equipment CQV documents

  • 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.

  • 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.

image_edited_edited.png

Welcome to Bench2batch! We're thrilled to have you here.

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

ChatGPT Image Oct 31, 2025, 10_22_44 PM_

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.”
bottom of page