
LAIZ Regulatory Science Consulting
We combine regulatory guidelines and science-based evidence to meet product quality goals at every stage of development.
This approach is established in solid understanding of ICH, WHO, EMA & FDA guidelines for biotherapeutic product development. We work towards the integration of quality aspects into preclinical and clinical outcomes.
Our purpose is to help clients advance in the discovery and commercialization of safe, efficacious, and affordable biologics that will ultimately improve patients quality of life.
Our Focus
Chemistry, Manufacturing, and Controls (CMC)
Development of a quality target product profile (QTPP), analytical method development/validation, release and stability testing, analytical method development/validation, comparability exercises.
Immunogenicity
Analytical, translational, and clinical aspects of immune-related responses to biotherapeutics.
How we can help
Chemistry, Manufacturing, and Controls (CMC)
Quality by Design (QbD) principles enable the simultaneous evaluation of multiple aspects of product quality to ensure that it consistently meets clinical safety and efficacy.
Definition of developmental objectives early in development can accelerate manufacturing process optimization, validation of “fit-for-purpose” analytical methods for release and stability testing, and foundation of robust quality management systems.
Immunogenicity
Immunogenicity prediction and evaluation requires the integration of quality, preclinical, and clinical aspects of a biotherapeutic development.
Defining the immunogenicity of new product modalities (oligonucleotides, peptides, gene and cell therapy) can benefit enormously from applying an immunogenicity risk-based assessment approach.
A good identification of risk factors is crucial to identify the relevant immune mediators and define a “fit-for-purpose” bioanalytical strategy for clinical testing. A well-validated assay enables interpretation of unwanted immune responses in relationship with pertinent treatment outcomes, such as drug exposure and efficacy.
High-quality regulatory submissions
A high-quality submission is one that presents data in clear and concise manner so it can be appropriately assessed by regulators.
A well-connected storyline lessens the number of inquiries from regulatory agencies and smoothens the path to approval of marketing applications and post-marketing supplements.
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, autologous/allogeneic cell therapy)
We work with you along every step of your product development
Pre clinical
Starting at the candidate selection stage, LAIZ helps you define your product quality target product profile (QTPP), define critical quality attributes (CQAs), and guide your method development and process controls.
Immunogenicity prediction studies are part of your candidate selection.
Clinical
A good understanding of product quality attributes is crucial for quality consistency, optimal safety, and therapeutic effect during clinical development.
The preparation of high-quality regulatory documentation based on cohesive data presentation facilitates review and limits the number of information requests.
Late Development & Submission
Changes in product quality are inherent to their life-cycle.
Demonstrating product quality comparability after manufacturing changes relies on a well-defined evaluation of risks on CQAs.
Commercial Products
LAIZ advices you to mitigate the consequences of quality changes, due to process optimization, process transfers or drifting in QC method performance, to minimize the impact in drug availability
My goal is to help you avoid drug shortages that could jeopardize the patients quality of life.
Get in Touch!
Contact us to schedule a consultation and enhance your product success.