Valin Bio
Consultancy and services company focused on development and commercialization of biologics, with emphasis on biosimilars and biobetters. Offers capabilities spanning R&D, analytical characterization, process development and scale-up, facility and process engineering, quality systems and cGMP manufacturing consulting, and project management for biotechnology projects. Describes multi-decade experience and a pilot plant for scale-up activities.
Industries
Products
Biosimilars / Biobetters portfolio (unspecified)
Company states it has developed a portfolio of biosimilars and biobetters; individual product details are not specified on the site.
Biosimilars / Biobetters portfolio (unspecified)
Company states it has developed a portfolio of biosimilars and biobetters; individual product details are not specified on the site.
Services
R&D and analytical development
Assay development, analytical characterization, stability studies, strain development and pilot-scale R&D to support biologics development.
Process engineering and scale-up services
Design and optimization of manufacturing processes, process documentation (BFD, PFD, P&ID), and technology transfer support for cGMP production.
Quality, validation and regulatory support
Development of quality management systems, validation master plans, DQ/IQ/OQ/PQ execution support, process validation and CMC documentation assistance.
Project management for biotech facility and product programs
Program management covering planning, site selection, budgeting, RFP development, contractor oversight, and acceptance testing for biotech projects.
cGMP manufacturing consulting
Advisory services to establish cGMP manufacturing readiness and operations for biologics.
R&D and analytical development
Assay development, analytical characterization, stability studies, strain development and pilot-scale R&D to support biologics development.
Process engineering and scale-up services
Design and optimization of manufacturing processes, process documentation (BFD, PFD, P&ID), and technology transfer support for cGMP production.
Quality, validation and regulatory support
Development of quality management systems, validation master plans, DQ/IQ/OQ/PQ execution support, process validation and CMC documentation assistance.
Project management for biotech facility and product programs
Program management covering planning, site selection, budgeting, RFP development, contractor oversight, and acceptance testing for biotech projects.
cGMP manufacturing consulting
Advisory services to establish cGMP manufacturing readiness and operations for biologics.
Expertise Areas
- Biosimilar and biobetter development
- Bioprocess development and scale-up
- cGMP manufacturing consulting
- Process engineering and facility design
Key Technologies
- Recombinant protein expression
- Bacterial and eukaryotic cell fermentation
- Protein purification
- Formulation development