Exclusive Services
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.
1
Scale Up & Technology Transfer
We support seamless scale-up and first-time-right technology transfer from development to GMP manufacturing and across CDMOs.
Key capabilities include:
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Facility and equipment fit assessments
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Process risk assessments and gap analysis
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Scale-up strategy and operating space definition
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Comprehensive process descriptions and flow diagrams
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Manufacturing Process Records (MPRs) review and readiness support
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Tech transfer packages and CDMO transition support
Our approach ensures technical readiness, minimizes surprises at scale, and aligns development knowledge with manufacturing realities.
2
Process Characterization
We design and execute robust process characterization strategies that define process understanding and support regulatory filings.
Key capabilities include:
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FMEA risk assessment to identify pCPPs
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Process characterization protocols and study designs
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Risk-based CPP and CQA identification (ICH Q8/Q9 aligned)
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DOE strategy development and execution support
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Data analysis, interpretation, and justification of operating ranges
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Process characterization reports and summary documents
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Bench2Batch focuses on building scientifically defensible operating spaces that are scalable, controllable, and inspection-ready.
3
At-Scale Process Performance Qualification (PPQ)
We lead and support PPQ activities to demonstrate consistent, reproducible performance at commercial scale.
Key capabilities include:
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Process Validation Master Plans (PVMPs)
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PPQ risk assessments and sampling strategies
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PPQ protocols and execution support
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Statistical data analysis and performance evaluation
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PPQ summary reports and regulatory responses
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Our PPQ approach integrates prior knowledge, process characterization outcomes, and real-world manufacturing constraints.
4
Commercial Manufacturing Support (CPV & APQR)
We provide ongoing lifecycle support to ensure continued process control and regulatory compliance post-approval.
Key capabilities include:
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Continued Process Verification (CPV) program design
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CPV SOPs, monitoring plans, and
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CPV reports
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Trend analysis and statistical evaluation
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Annual Product Quality Reviews (APQRs)
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Regulatory inspection support and remediation
Bench2Batch helps organizations move from reactive monitoring to proactive, data-driven process control.