Our Approach
LAIZ supports biologics and advanced therapy programs across the full development lifecycle — from candidate selection through clinical development, regulatory submission, and commercial lifecycle management.
Our approach integrates immunogenicity strategy, CMC expertise, and regulatory insight to anticipate risks early, align scientific decisions with agency expectations, and guide complex biologics and gene therapy products through critical development milestones.
Pre Clinical
Immunogenicity
Planning and interpretation of prediction studies: in silico (netMHC-pan), in vitro assays (MAPPS, PBMC, DC-TC assay, TLR-indicator cell lines), in vivo TG mouse systems
Preparation of immunogenicity risk assessments for initiation of clinical trials (IND, CTA)
Support bioanalytical development and validation
FDA & EMA Regulatory support: INTERACT, Type A (hold comments), Type B (preIND), Type C, Type D meetings, Scientific Advice, Kick-off and PRIME meetings
Due diligence
CMC
Support with analytical method development
Support in the planning, execution, and evaluation of manufacturing process development
Regulatory strategy to define QTPP
Regulatory support: preparation for scientific and pre-IND meetings
Due diligence - Product developability
Clinical
Late Development & Submission
Commercial Products
Immunogenicity
Support for ADA and NAb assay validation
Interpretation of quality, PK/PD, and immunogenicity results for optimal benefit:risk evaluation
FDA & EMA Regulatory support: Type A (hold comments), Type B (EOP, preBLA, preNDA, preANDA), Type C, Type D, Scientific Advice, pre-submission meetings
Due diligence
CMC
Support with analytical method validation - Potency and Impurity
Support in the planning, execution, and evaluation of comparability exercises
Regulatory support: preparation for regulatory meetings: Type A (hold comments), Type B (EOP, preBLA, preNDA, preANDA), Type C, Type D meetings
Due diligence
Immunogenicity
Life-cycle management of immunogenicity methods
Interpretation of new safety signals in the context of immunogenicity data
Preparation of Integrated Summary of Immunogenicity (ISI) for novel biotherapeutics and biosimilars
CMC
Life-cycle management of QC methods
Support in the planning, execution, and evaluation of manufacturing changes in support of commercial process
FDA & EMA Regulatory support: Type A (hold comments), Type B (EOP, preBLA, preNDA, preANDA), Type C, Type D, Scientific Advice meetings
Due diligence
Immunogenicity
Life-cycle management of immunogenicity methods
Interpretation of new safety signals in the context of immunogenicity data
Immunogenicity risk assessments for 505(b)(2) and 505(j) applications and complex biologics
CMC
Life-cycle management of QC methods
Support in the planning, execution, and evaluation of manufacturing changes requiring comparability studies
FDA & EMA Regulatory support: preparation for Type A/B/C/D meetings, post-marketing studies
Scientific Rigor. Regulatory Strategy. Lifecycle Perspective.
We apply disciplined scientific principles and current regulatory standards to identify and mitigate risks that can delay approval, compromise product quality, or impact patient safety.
By integrating immunogenicity, CMC, and regulatory strategy from early development onward, we help biologics and advanced therapy programs move confidently through stage gates and regulatory review.