TriLink BioTechnologies, part of Maravai LifeSciences, is a best-in-class contract development and manufacturing organization (CDMO) for synthesis of nucleic acids, NTPs and mRNA capping analogs. TriLink has scale-up expertise and unique production capabilities of mRNA, oligonucleotide & plasmid for companies focused on therapeutic, vaccine, diagnostic and biopharmaceutical breakthroughs. TriLink’s proprietary CleanCap® mRNA co-transcriptional capping technology simplifies mRNA manufacturing by removing additional enzymatic steps, resulting in high capping efficiency and improved yields over traditional co-transcriptional capping methods.​TriLink’s CDMO services offer a range of manufacturing grade products from discovery-grade (RUO) to its customizable intermediate-grade - GMPLink™ to full GMP-grade with scale-up and technology transfer expertise. TriLink operates a quality system in compliance with ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 19, APIs for Use in Clinical Trials, and ISO 9001:2015 standards.TriLink continues to expand its cGMP and general mRNA, oligonucleotide & plasmid manufacturing capacity at its new global headquarters to support therapeutic, vaccine and diagnostic customers.TriLink BioTechnologies is online at www.trilinkbiotech.com.

A consulting firm focusing biopharmaceuticals including peptides, proteins, oligonucleotides (siRNA) and conjugates. Services offered include:•Solution and solid-phase synthesis and manufacture peptides including analysis, method development and purification•Protein expression analysis and purification •Solid-phase synthesis of oligonucleotides including analysis, method development and purification •Conjugation of peptides, oligonucleotides and small molecules to proteins and nanoparticles•Pegylation chemistry including analytical characterization•Pre-formulation studies including analysis of by HPLC and LCMS and determination of routes of degradation. •Lipid nanoparticle formulations of siRNAs, including manufacture and scale-up, characterization and analysis.

Directed a team of up to 16 chemists, formulator and engineers overseeing the internal and external manufacture of all critical components for Marina Biotech’s proprietary siRNA APIs and lipid nanoparticle delivery formulations. Instituted quality initiatives focused on process development and analytical improvements that resulted delivery of high quality formulations to internal and external customers Key Accomplishments:•Directed the GMP manufacture of 1 kg of UNA phosphoramidite at CMO•Developed manufacturing process for novel DiLA2 cationic lipid. Identified CMO and transferred process •Led process development efforts for the manufacturing process of DiLA2-based nanoparticle formulation for siRNA bladder cancer program •Identified and selected CMO for GMP manufacture of siRNA API for bladder cancer program•Successfully led feasibility study with Mirna Therapeutics for evaluation of company’s LNP-based delivery vehicle. Evaluation identified SMARTICLE-based miRNA mimetic formulation highly efficacious in cancer models•Successfully transferred manufacturing process and analytical method for SMARTICLE formulation to Mirna•Led a group of synthetic chemists that developed novel process to synthesize companies CRN (LNA-like) nucleoside technology. Technology successfully transferred to Novartis•Devised and implemented research plan that resulted in 10-fold improvement in potency and doubled therapeutic index for DiLA2-based lipid nanoparticle formulation for siRNA delivery

Lead a 4 person team developing chemistry, analytical methods and formulations for the Pepducin peptide technology.Key Accomplishments:•Developed formulations based upon GRAS excipients enabling in vivo testing of highly insoluble lipopeptides•Established SAR plan for Pepducin platform and identified leads two programs•Directed the scale up of lipopeptides from mg to gram scales to support in vivo testing•Identified CMO and transferred manufacturing process for lead lipopeptide to enter into preclinical development

Led the 18 member Chemistry & Formulations Group in this young organization, overseeing drug product processes and managing preclinical development. Additionally planned and prioritized experiments and reviewed and approved research study protocols. Develop and co-presented corporate presentations for investors and partners. Key Accomplishments:•Directed siRNA delivery technology feasibility study with Novartis. Technology was non-exclusively licensed by Novartis in May 2009 for $7.5 million•Established pilot manufacturing lab that supplied gram quantities of siRNAs for formulation studies and in vivo evaluation•Developed novel pH triggered nanoparticle forming peptides for siRNA delivery which effectively knockdown liver targets in vivo •Led the due diligence team that in-licensed unlocked nucleic acid (UNA) technology from University of South Denmark. •Led development of company’s novel UsiRNA molecules that utilizes unlocked nucleic acid chemistry

Senior Director, Chemistry and Formulations • 2007-2008Supervised 20 senior and mid-level scientists, with direct oversight for experiment planning, prioritization, and review and approval. Managed synthesis of in-house peptides, oligonucleotides, and small molecules for other research groups. Proposed novel amino acid-based siRNA drug delivery technology to CEO and was rewarded with an expanded role in company to direct the RNAi Delivery Group Key Accomplishments:•Directed the manufacture of salmon calcitonin bulk drug product for Phase III clinical studies•Successfully led similarity protocol that determined no increase in aggregation of salmon calcitonin nasal spray drug product compared to reference listed drug as a response to FDA objections to an ANDA application•Established pilot manufacturing and supplied multi-gram quantities of peptide and PEGylated peptide APIs for formulation studies•Developed synthetic processes and analytical methods for PEGylation (200 Da to 20000 Da) of numerous peptide APIs to support preclinical testing•Devised and implemented research plan of a new lipid nanoparticle technology that I invented from inception of idea to proof of concept in animal studies•Awarded double the standard stock grant bonus, an honor reserved for less 5% of staff

Headed a 20 member team responsible for the synthesis, purification, and analysis of peptides, oligonucleotides and peptide oligonucleotide conjugates. Expanded role in the company to oversee the manufacture of peptide APIs at Contract Manufacturing Organizations for clinical studies as well as oversee pre-formulation and forced degradation studies of peptide APIsKey Accomplishments:•Directed the scale up and delivery of 1 kg of a PTH1-34 bulk drug substance at two different CMOs for phase II clinical trials against aggressive deadlines•Established process chemistry lab for the synthesis of novel peptides leads for preclinical development•Invented a novel peptide conjugation chemistry to delivery siRNAs and conjugated over 100 different peptides and proteins to a variety of siRNAs for in vivo evaluation•Inventor of novel phage display library based upon Trp cage peptide.•Awarded double the standard stock grant bonus, an honor reserved for less 5% of staff

Early stage Biotech Company developing peptide-protein conjugates as vaccines to treat nosocomial infections•Direct activities of the peptide/protein chemistry department including supervising four chemists•Synthesized multiple disulfide constrained peptide antigens and conjugated to a variety of carrier proteins including tetanus toxoid, diphtheria toxoid, KLH and liposomes•Developed peptide and peptide-protein conjugation manufacturing processes and analytical methods and successfully transferred to CMO•Directed the GMP manufacture of two clinical lots of a peptide-protein conjugate vaccine serving as man in the plant•Prepared pre-IND package and CMC section for successful IND package to Health Canada•Directed purification and characterization of humanized monoclonal antibody as part of a program to develop novel therapeutics for P. aeruginosa infections

Supervisor: Bob HodgesUtilized secondary structure constraints to stabilize helical peptides and applied to the development of constrained combinatorial peptide libraries, protein minimization of helical proteins and novel antibacterial peptides.