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CMC Expertise Accelerating Biologics Development for 20 Years and Counting

Working with my co-founders, colleagues, and clients on many fascinating projects over the last twenty years has been an honor. From the founding of the firm with former Pfizer colleagues until today, we have specialized in supporting the CMC and regulatory programs...

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

    • Product characterization
    • Analytical method development
    • Critical Quality Attributes understanding
    • CDMO selection support
    • On-site batch run support
    • Process control strategies
    • Microbial monitoring strategies
    • 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 of Experience

Consultants

Clients

projects

Oligonucleotide & Peptide Therapeutic Resources

BioTechLogic Perspectives on Oligonucleotide Therapies

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

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...