Oligonucleotide & Peptide Therapeutic Development & Commercialization
Oligonucleotide and peptide therapeutics offer promising treatments for a wide range of medical conditions.
Specifically, they provide the opportunity to develop therapeutics that affect protein targets that cannot be effectively treated by small-molecule or protein therapeutics. BioTechLogic’s team of experts has deep expertise and experience working on the front lines of oligonucleotide and peptide therapeutic development, from preclinical to market.
Complete Oligonucleotide & Peptide Therapeutic Lifecycle Support Services
BioTechLogic has extensive experience with oligonucleotide- and peptide-based therapeutic development and commercialization. We have extensive experience working with advanced analytical methods that better characterize and quantitate both the oligonucleotide and peptides of interest, as well as any synthesis contaminants.
Oligonucleotide & Peptide Therapeutic Development & Production
BioTechLogic has done a great deal of work with oligonucleotide and peptide products, including process validation work for drug substance, drug product, and oligo adjuvant.
How BioTechLogic Can Help
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- Product characterization
- Analytical method development
- Critical Quality Attributes understanding
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- CDMO selection support
- On-site batch run support
- Process control strategies
- Microbial monitoring strategies
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- Commercialization plans
- Formulation development reports
- Chromatography column troubleshooting
- Regulatory filing support
Oligonucleotide & Peptide Therapeutics CMC Services
CMC Strategy
Quality Assurance
Analytical Services
Regulatory Consulting & Submissions Support
Process Development & Validation
Contract Services & Tech Transfer Support
Supply Chain Management
Inspection Readiness
Project Management
Years
Consultants
Clients
projects
Oligonucleotide & Peptide Therapeutic Resources
BioTechLogic Perspectives on Oligonucleotide Therapies
Recently, I sat down with Tracy TreDenick, BioTechLogic's Head of Regulatory and Quality Assurance, to learn more about her insights and experiences from the extensive oligonucleotide therapeutics work BioTechLogic has done. Q: Briefly describe the types of work you...
Oligonucleotide Therapeutics Near Approval
Successful late-stage clinical oligonucleotide therapeutic trials could mark the maturation of a new drug development platform, but the path to commercialization is not without hurdles. Cold Spring Harbor Laboratory molecular geneticist Adrian Krainer was at a...
White Paper: Oligonucleotides – Opportunities, Pipeline and Challenges
White Paper Oligonucleotides - Opportunities, Pipeline and ChallengesAlthough meaningful progress toward the development of oligonucleotide therapeutics began in the 1970s, nearly a half century later, only three oligonucleotide drugs have been approved by the FDA....
