Nitto Avecia
Nitto Avecia Pharma Services is a leading provider of high-quality chemistry, manufacturing, and control (CMC) services for the pharma, biotech, and medical device industries. With over 30 years of experience, the company specializes in oligonucleotides and offers comprehensive solutions including analytical services, aseptic fill finish, and end-to-end oligonucleotide manufacturing. Their facilities are GMP-compliant and FDA-inspected, supporting the development of gene therapies and cell-based assays. The company is committed to creating value through innovative products, processes, and technologies, and emphasizes a culture of diversity, inclusion, and collaboration.
Industries
Nr. of Employees
medium (51-250)
Nitto Avecia
Irvine, California, United States, North America
Products
Oligonucleotide Manufacturing
Provides comprehensive manufacturing solutions for oligonucleotide therapeutics, from preclinical to commercial supplies.
Aseptic Fill Finish
Offers aseptic fill finish services for oligonucleotides and other drug products, ensuring quality and consistency.
Analytical Services
Provides a wide range of analytical and microbiological testing services, including compendial testing, structural chemistry, and stability studies.
Parenteral Manufacturing
Specializes in small volume parenteral manufacturing, including formulation development, compounding, and aseptic filling.
Elemental Impurity Analysis
Conducts elemental impurity analysis using modern instrumentation to comply with USP and ICH guidelines.
Extractables & Leachables
Performs systematic studies to identify and quantify leachable and extractable impurities in drug products and delivery systems.
Oligonucleotide Manufacturing
Provides comprehensive manufacturing solutions for oligonucleotide therapeutics, from preclinical to commercial supplies.
Aseptic Fill Finish
Offers aseptic fill finish services for oligonucleotides and other drug products, ensuring quality and consistency.
Analytical Services
Provides a wide range of analytical and microbiological testing services, including compendial testing, structural chemistry, and stability studies.
Parenteral Manufacturing
Specializes in small volume parenteral manufacturing, including formulation development, compounding, and aseptic filling.
Elemental Impurity Analysis
Conducts elemental impurity analysis using modern instrumentation to comply with USP and ICH guidelines.
Extractables & Leachables
Performs systematic studies to identify and quantify leachable and extractable impurities in drug products and delivery systems.
Services
Analytical services
Comprehensive analytical support across the drug development lifecycle, including method development, validation, stability, compendial testing, extractables/leachables, elemental impurity testing, and microbiology.
Gene therapy analytical support
Assay development and testing for gene therapy programs, including analytics relevant to viral vectors, cell therapies, and genome-editing constructs.
Cell-based assay development
Cell culture and cell-based assay method development and testing to support biologics and cell therapy development.
Aseptic fill-finish and parenteral manufacturing
Sterile filling and parenteral manufacturing services from compounding to final fill-finish for clinical supplies, executed in GMP-compliant facilities.
Formulation development (including oligonucleotides)
Formulation optimization and development services, including oligonucleotide-specific formulation strategies and lyophilization cycle development.
Extractables and leachables assessment
Testing and evaluation to characterize extractables and leachables from container/closure systems to support safety and regulatory requirements.
Analytical services
Comprehensive analytical support across the drug development lifecycle, including method development, validation, stability, compendial testing, extractables/leachables, elemental impurity testing, and microbiology.
Gene therapy analytical support
Assay development and testing for gene therapy programs, including analytics relevant to viral vectors, cell therapies, and genome-editing constructs.
Cell-based assay development
Cell culture and cell-based assay method development and testing to support biologics and cell therapy development.
Aseptic fill-finish and parenteral manufacturing
Sterile filling and parenteral manufacturing services from compounding to final fill-finish for clinical supplies, executed in GMP-compliant facilities.
Formulation development (including oligonucleotides)
Formulation optimization and development services, including oligonucleotide-specific formulation strategies and lyophilization cycle development.
Extractables and leachables assessment
Testing and evaluation to characterize extractables and leachables from container/closure systems to support safety and regulatory requirements.
Expertise Areas
- CMC services for pharmaceutical and biotech products
- Analytical method development and validation
- Oligonucleotide formulation and analytics
- Aseptic fill-finish and parenteral manufacturing
Key Technologies
- Analytical chemistry methods
- Photostability and stability testing
- Extractables and leachables analysis
- Elemental impurity testing