Master Batch Records

Significantly reduce the time & effort you need to
securely create and distribute MBRs.

An Introduction to Master Batch Records

Required by the U.S. Food & Drug Administration, master batch records (MBRs) contain the instruction, recipe or formula, and specific manufacturing process for a particular product. Biopharmaceutical and biotechnology companies must generate MBRs, also known as master production records (MPRs) or master manufacturing formulas (MMFs), for each product formulation and batch size.

Typically, MBRs include:

  • Manufacturing process information          
  • General manufacturing instructions        
  • Equipment cleaning requirements          
  • List of raw materials          
  • Expected yield of each batch          
  • List of abbreviations          
  • Revisions and changes

Why You Need CellPort MBRs

Here’s how CellPort saves you time and effort with digital MBRs.

Biopharmaceutical
From generic drug development to in vitro efficacy testing, cells aid in the end-to-end production of modern medicines. How biopharma R&D and manufacturing labs manage cells makes all the difference between getting FDA approval for commercial products, or not. CellPort helps your lab achieve more reproducible, ready-to-scale results. 
Biotechnology
Built to optimize all upstream and downstream bioprocessing operations, CellPort helps biotech companies to experiment, develop, and manufacture – CellPort makes it easy to manage your end-to-end operations, from cell lineage tracing to product packaging and beyond. CellPort helps your lab scale commercial products that adhere to GLP and GMP standards.
CRO & CDMO
For contract research and development labs to operate more efficiently, CellPort supports adherence to SOPs through automated time & scheduling, centralized communications, customized reporting, and a library of configurable protocols and assays.
Cellular Agriculture
Harvest a more plentiful cell culture – CellPort helps ensure a reliable and consistent supply of cells, with complete tracking and oversight into the scaffolds, serums, and cell culture environments. From R&D to GMP, CellPort delivers the tools you need to develop safer, purer cellular or acellular products.
Cellular Agriculture
Harvest a more plentiful cell culture – CellPort helps ensure a reliable and consistent supply of cells, with complete tracking and oversight into the scaffolds, serums, and cell culture environments. From R&D to GMP, CellPort delivers the tools you need to develop safer, purer cellular or acellular products.

Generate MBRs in Just Minutes

Quickly populate MBRs from a library of customized protocols, workflows, and assays.

Securely Distribute MBRs

Enable authorized users to access and edit MBRs from any device, with built-in security and encryption protocols to protect your valuable IP.

Upskill New Employees

When it comes time to scale your operations, digital protocols simplify the learning curve and make it easy for new technicians to master their workflows.

Electronic Signatures & Approvals

Simply use electronic signatures for approvals with fully verifiable audit trails – compliant to 21 CFR Part 11 / Annex 11 Compliance for electronic signatures.

Update in Real Time with Tracked Changes

Ensure your people are all using the same documents, with complete audit trails of access and modifications when it comes time for compliance reports.
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