USP 1043 Guidelines

USP <1043> Guidelines for Ancillary Materials (AMs) for Cell, Gene, and Tissue-Engineered Products provide a framework for assessing the quality, safety, and suitability of materials used in the manufacturing of advanced therapies. These guidelines help manufacturers ensure that ancillary materials (AMs) do not negatively impact product quality, efficacy, or patient safety.

Polymer Vial 2ml 5ml 10ml for cell and gene therapies

Key Aspects of USP <1043> for Ancillary Materials (AMs)

1. Definition of Ancillary Materials (AMs)

Ancillary materials are substances, reagents, or components used during the manufacturing of cell, gene, and tissue-engineered therapies but are not intended to be present in the final product. Examples include:

Enzymes (e.g., trypsin, collagenase)

Cell culture media and supplements

Growth factors and cytokines

Scaffold materials and biomaterials

Cryopreservation agents

2. Risk-Based Approach for AM Qualification

USP <1043> emphasizes a risk-based approach to evaluating AMs, considering factors like:

✅ Source & Purity: Origin of materials (animal-derived, recombinant, synthetic, etc.).

✅ Manufacturing Controls: Compliance with Good Manufacturing Practices (GMP).

✅ Potential Contaminants: Testing for endotoxins, mycoplasma, viruses, and residual solvents.

✅ Compatibility with Cells & Tissues: Ensuring AMs do not harm cells or alter therapeutic properties.

✅ Extractables & Leachables (E&L): Identifying potential chemical migration from AMs into final products.

3. Classification of AMs Based on Regulatory Expectations

AMs are categorized based on their level of regulatory control:

Tier 1: Highest quality AMs (e.g., GMP-grade, used in licensed biologics).

Tier 2: Non-GMP AMs with high purity but lower regulatory oversight.

Tier 3: Research-use-only (RUO) AMs with minimal regulatory compliance.

Tier 4: Uncharacterized AMs with unknown risk profiles (require extensive validation).