Our Method

How we work

LAIZ experience covers the full spectrum of biotherapeutic products: recombinant and synthetic peptides, oligonucleotides, recombinant proteins (enzyme replacement therapies, bi-specific monoclonal antibodies, fusion proteins, and antibody-drug conjugates), and cell & gene therapy (AAV-mediated, gene editing, and pluripotent stem cells). We work with you along every step of your product development.

Pre Clinical

1

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

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

Clinical

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

  • 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

Late Development & Submission

3

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

  • Preparation of Integrated Summary of Immunogenicity (ISI) for novel biotherapeutics and biosimilars

Commercial Products

4

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

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

My approach is to apply solid scientific principles and current regulatory guidelines to identify risks that can delay approval of new biologics or result in drug shortages due to poorly executed post- manufacturing changes. I specialized in those quality aspects of recombinant products that can compromise their overall benefit:risk profile. I start at the candidate selection stage and orient clients to get through the multiple clinical developmental stage-gates.