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Solutions / Biologics

Biologics CMC writing for proteins, antibodies and advanced therapies.

Cell banks to purified bulk, characterisation by Q6B, viral clearance and the retrovirus safety margin, fill-finish and devices, stability by Q5C, comparability by Q5E, biosimilar similarity, and cell and gene therapy release testing.

Start the 14-day trialSee the Module 3 map

Written for biologics

Process, characterisation, viral safety and stability for biotechnology products

A.2

Viral Safety Studio

Adventitious agents safety evaluation with the clearance and safety margin worked out.

  • Log reduction totals by Q5A(R2) rules
  • Retrovirus particles per dose and safety margin
  • Cell bank, unprocessed bulk and raw material checks
Follows ICH Q5A(R2) · Q5D · 3.2.A.2
Open Viral Safety StudioTraining guide
ATMP · 3.2.P.5

Cell & Gene Therapy CMC

Release testing and controls for AAV, lentiviral, CAR-T and cell therapy products.

  • Expected tests for the product type
  • VCN, viability, RCL and phase-appropriate potency
  • Chain of identity, vector, ancillary materials, GMO (EU)
Follows FDA gene therapy CMC (2020) · EU GMP Part IV · Ph. Eur. 5.14
Open CellTraining guide

Also used

Batch analysis, packaging and method validation, shared with small molecules

Batch analysis, container closure, excipients, facilities and method validation switch to the biologics rules when you pick a biologic: Batch Analysis, Container Closure, Excipients, Facilities and Equipment and Method Validation.

Viral clearance by ICH Q5A(R2), worked through

For a CHO-derived antibody, steps with the same mechanism are not double counted, which leaves a retrovirus safety margin of 9.3 log10.

The Viral Safety Studio
app.cmcfy.com/app/viral-safety
Viral Safety Studio: retrovirus safety margin 9.3 log10 and clearance per model virus

Module 3 map

The CTD Module 3 map: which module writes each section

Drug substance

3.2.S
  1. S.1General informationComposition & General Info
  2. S.2Manufacture, route, starting materialsProcess & Controls Writer
  3. S.2Manufacture, cell banks, process validation, comparabilityBiologics Process Writer
  4. S.3Structure and impuritiesComposition · Impurity & Risk Studio
  5. S.3Characterisation (Q6B) and impuritiesBiologics Characterisation
  6. S.4Specification and justificationSpecification Builder
  7. S.4Specification with potency and K/M endotoxinBiologics Characterisation
  8. S.4.2–4.3Procedures and validationMethod Validation Studio
  9. S.4.4 · S.5Batch analyses, reference standardsBatch Analysis & CoA
  10. S.6Container closureContainer Closure & E&L
  11. S.7StabilityStability Studio
  12. S.7Stability by Q5C: potency, aggregates, freeze-thawBiologics Stability Studio

Drug product

3.2.P
  1. P.1Description and compositionComposition & General Info
  2. P.2Pharmaceutical developmentDevelopment Studio
  3. P.3Manufacture, batch formula, flow diagramProcess & Controls Writer
  4. P.2 · P.3Formulation, fill-finish, media fills, devicesBiologics Drug Product Writer
  5. P.4Control of excipients, animal origin, novel excipientsExcipients Writer
  6. P.5Specification, procedures, batchesSpecification Builder · Batch Analysis
  7. P.5Specification with particles, sterility, potencyBiologics Characterisation
  8. P.7Container closure and E&LContainer Closure & E&L
  9. P.8Stability and commitmentsStability Studio
  10. P.8Stability, in-use and shipping studiesBiologics Stability Studio

Appendices and regional

3.2.A · 3.2.R
  1. A.1Facilities, cleanroom grades, cleaning limitsFacilities & Equipment Writer
  2. A.2TSE/BSE statement for excipientsReport Reviewer checks it
  3. A.2Viral safety: Q5A(R2) clearance and retrovirus marginViral Safety Studio
  4. A.3Novel excipients: full data setExcipients Writer
  5. R · USExecuted batch records, method validation packageQOS Composer
  6. R · EUProcess validation scheme, CEP/ASMF, deviceQOS Composer

Summary and checks

Module 2.3 · any report
  1. 2.3Quality Overall Summary from every tool's summary fileQOS Composer
  2. ZipeCTD folder structure with all sectionsQOS Composer
  3. CheckUpload any section, PDF or scan and see what is missingReport Reviewer
  4. ReportsStability, validation, OOS, deviation, CAPAStudios
  5. ChangesPost-approval changes: US supplement or EU variation typeChange Classifier

Sections in amber use the biologics rules: ICH Q5A(R2), Q5B, Q5C, Q5D, Q5E and Q6B.

Sections in amber use the biologics rules: ICH Q5A(R2), Q5B, Q5C, Q5D, Q5E and Q6B.

Judge it on a section you already wrote

Paste a section into the Report Reviewer and read what it finds. Nothing you paste leaves your computer.

Open the Report ReviewerSee pricing