Scale Up & Tech Transfer

Facility Fit & Risk Assessments

We conduct holistic assessments of manufacturing sites to ensure compatibility with your product's technical and regulatory requirements. Our services include:

• Facility fit gap analysis (equipment, utilities, flow paths)

• Cleaning validation and hold-time risk evaluations

• Environmental monitoring and classification alignment

• Regulatory risk identification for pre-approval inspections

• Risk scoring and mitigation planning across unit operations

Process Flow Diagrams (PFDs)

We create structured visualizations of your end-to-end process, customized for stakeholder clarity and CDMO alignment. Deliverables include:

• Unit operation breakdown with IPCs and CPPs

• Process interface mapping (e.g., upstream/downstream handoffs)

• Integration of equipment, material flows, and control strategy elements

• Exportable files for inclusion in development reports and tech transfer packages

Bills of Materials (BOMs)

We generate robust, stage-specific BOMs that align with your CDMO’s sourcing and inventory systems. Our BOM development includes:

• Detailed lists of raw materials, consumables, single-use assemblies

• Version-controlled documents aligned with each unit operation

• Clear linkage to PFDs, MBRs, and cost-of-goods models

• Classification by GMP/non-GMP, criticality, and sourcing risk

Protocols

We author technical protocols that are precise, defensible, and ready for execution. Types include:

• Technology transfer protocols with acceptance criteria

• Equipment qualification and facility readiness verification

• Mixing studies, hold-time validation, SIP/CIP protocols

• Protocols aligned to PPQ, Stage 2 PV, and CPV readiness

Batch Records (MBRs/eBMRs)

We write and refine master batch records that are GMP-compliant, executable, and inspection-ready. Our services cover:

• Drafting and QA alignment for upstream, downstream, and fill/finish MBRs

• Parameter mapping to ensure control strategy integration

• Linking to equipment, material lists, and sampling plans

• Supporting conversion to electronic BMR formats (eBMR)

Run Summary Reports

We consolidate campaign data into comprehensive run summaries that support QbD, investigations, and future optimization. Our reports feature:

• End-to-end traceability of process parameters, deviations, and yield

• Summary tables of in-process control (IPC) data and results

• Observations, corrective actions, and continuous improvement notes

• Readiness for regulatory submissions and internal review