Article
Drug Product Formulation Development for Biologics — pH, Tonicity, Aggregation
Biologic drug product formulation development involves trade-offs that do not exist for small molecules: the excipients that stabilize a protein against aggregation may affect syringeability; the pH that…
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Article
Drug Product Formulation Development for Biologics — pH, Tonicity, Aggregation
Biologic drug product formulation development involves trade-offs that do not exist for small molecules: the excipients that stabilize a protein against aggregation may affect syringeability; the pH that…
Article
AI-ML for CMC Specification and Shelf-Life — Real Applications Now
Pharmaceutical companies are deploying AI and machine learning tools for CMC specification setting and shelf-life prediction — but the regulatory framework for using these tools in a GMP-regulated…
Article
Biologics Stability — ICH Q5C and the Stability-Indicating Attribute Strategy
"The stability-indicating nature of the assay methods used in the biologic stability program has not been demonstrated for the protein degradation pathways observed under stressed conditions — specifically,…
Article
Accumulus Synergy — The Industry Platform Reshaping Regulatory Submission
Accumulus Synergy is the first industry-wide regulatory submission platform built specifically to integrate with FDA's and EMA's structured data APIs — and pharmaceutical companies that are not yet…
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eCTD v4 Technical Architecture — What Changes for CMC Submissions
eCTD version 4.0 represents a fundamental redesign of the electronic Common Technical Document — not a format update but an architecture change from document-centric to data-centric submissions —…
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Biologics Specifications and Potency — Building a BLA-Ready Release Package
"The potency assay acceptance criterion of 50–200% (relative to reference standard) is too wide to provide meaningful assurance of biological activity — please provide a scientific justification for…
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ISO IDMP 11238 — Substance Identification and UNII Registration
A pharmaceutical company that does not have UNII registrations for all of its active substances has a regulatory data foundation problem that will surface at every submission —…
Article
Biologics Impurity Profile — HCP, HCD, Leachables, and Product-Related Variants
The impurity framework for biologic drug substances is categorically different from the ICH Q3A small molecule framework — and applying Q3A logic to a biologic impurity profile is…
Article
ISO IDMP 11615 — The Data Model Behind Global CMC Harmonization
ISO 11615 is the international standard that defines how medicinal products are uniquely identified globally — and understanding its data model is the key to understanding why EMA's…
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Characterization — ICH Q6B and the Extended Characterization Evidence Package
ICH Q6B — Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products — defines the characterization framework for biologic drug substances that has been in force since 1999.…
Article
EMA SPOR PMS — Product Management Service and Variation Maintenance
EMA's Product Management Service assigns the EU product identifier that is required in electronic product information and variation submissions — and managing this identifier accurately across a complex…
Article
Biologics Process Validation — FDA 2011 Stage 1-2-3 Applied to Bioreactor Manufacturing
The FDA Process Validation Guidance of 2011 applies to biological drug substances as directly as it applies to small molecules — but the biological complexity of upstream cell…
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