LEVEL UP YOUR NUCLEIC ACID-BASED THERAPY

Uniting innovative process and analytical development with molecular design and discovery to streamline development of next-gen nucleic acid-based therapies.

Nucleic Acid Manufacturing

 

EXPERIENCE-DRIVEN
NUCLEIC ACID THERAPY DEVELOPMENT & MANUFACTURING

Building labs and capital assets for bioprocesses is both cost and labor intensive. To streamline the development of next-gen nucleic acid-based therapies and mRNA manufacturing, we unite and improve every component – processes, scale-up, raw material supplies, analytics and GMP strategy.

The end result — a network of high-performance facilities and digitally interconnected processes that we are building to help you reliably scale up production and meet demand.

Our aim is to help you save time and manufacturing costs by providing access to world-class expertise, and modular biomanufacturing capabilities at all scales.

 

Nucleic Acid Manufacturing Scientist

NUCLEIC ACIDS
CAPABILITIES

Product Types

  • Discovery: Full-service guide RNA (gRNA), mRNA, and LNP available in-house
  • High-quality GMP mRNA at mg to kg scale for drug substance/product available in-house​
  • Plasmid DNA for discovery and GMP is available through supply agreements from trusted partners for effective sourcing
  • GMP gRNA and oligos (ASOs and siRNA) are available through supply agreements from trusted partners for effective sourcing
  • GMP LNP capabilities coming soon

Accelerated Path To IND

  • Consultation and optimization on sequence design to increase expression and enable a robust, scalable workflow 
  • Process and analytical development (PAD)
  • Generation of material to support pre-clinical and tox studies
  • Scale-up and validated analytics all the way through formulation for mRNA
  • Release testing to power regulatory filings and clinical studies
  • Generate 1g of mRNA for fit-for-purpose clinical trials

Robust Clinical & Commercial Manufacturing

  • Manufacturing scale from milligram to kilogram certified through commercialization enabling vaccine, gene editing, cell therapy, and enzyme replacement programs
  • Integrated lipid nanoparticle (LNP) formulation and fill/finish - coming soon
  • A full panel of release and characterization analytics for drug substance/drug product and the knowledge of what regulators demand
  • Analytical and quality support
  • Extensive cleanrooms in the U.S. and Canada certified from Phase I to commercialization
  • GMP guidance and documentation

Experienced CMC & Regulatory Support

  • Seasoned regulatory team with an average of 20+ years of experience working alongside product development leaders to provide CMC and regulatory support from pre-clinical development to licensure
  • Multi-tiered support to fit your stage of product development and needs
Biomanufacturing Nucleic Acids Scientist

UNITING BEHIND A COMMON PURPOSE

Your science is purpose-built and fueled by commitment, like our approach to revolutionizing nucleic acid-based therapies. Discover where our goals intersect and let’s realize them together.

SPEAK WITH A NUCLEIC ACIDS EXPERT

Let’s Start a Conversation

You’ve no doubt filled out a million forms before. But this is the first one to us – and we’re excited to hear from you. Let’s see if your biomanufacturing needs and our capabilities are a good match.

NATIONAL RESILIENCE