Scale of production for RNA embedded within lipid nanoparticle

Nucleic acid therapeutics hold great promise for treating a wide range of diseases—we invite you to partner with us to reach your nucleic acid therapeutics development goals. Explore our portfolio of high-quality raw materials designed for your oligonucleotide and mRNA synthesis to help you move your project from development to manufacturing and commercialization. Thermo Fisher Scientific provides expertise, services, and support to help you accelerate your productivity and innovation.

Platforms enabling nucleic acid therapeutic manufacturing across the globe

Our manufacturing facilities and platforms, located in geographic raw material centers of excellence, are deeply rooted in enzymology, nucleic acid chemistry, bioprocessing, and lipid chemistry.

Products and services from centers of excellence for NA therapy workflow
Gene synthesis
Regensburg, Germany
IVT RNA synthesis
Vilnius, Lithuania
IVT RNA synthesis
Milwaukee, WI, USA
Transcript purification
Oslo, Norway and Bedford, MA, USA
Formulation and delivery
Carlsbad, CA, USA
ISO 9001 certified ISO 9001, 13485 certified ISO 9001 certified
  • Phosphoramidites
  • Modified nucleotides
  • Chemulation
  • Custom chemistry development and manufacturing
  • Delivery molecules
ISO 9001, 13485 certified ISO 9001 certified

TheraPure quality for mRNA and oligonucleotides synthesis

TheraPure reagents from Thermo Fisher Scientific are designed for pharmaceutical manufacturers looking for core building blocks to use in research and manufacturing. These reagents are crafted in facilities with thoroughly documented quality systems and audited by accredited drug products manufacturing authorization holders. Strategically designed and carefully manufactured following the principles of 21 CFR 210/211, The Rules Governing Medicinal Products in the European Union, volume 4 GMP Part II and ICH Q7, TheraPure reagents help build the solutions to today’s challenges.

The reagent attributes that differentiate TheraPure from catalog products include:

Table 1. Comparison of TheraPure reagents to catalog products by application.

  TheraPure reagents Catalog reagents
  GMP grade Research and clinical development grade Research use only (RUO)
Quality QMS
  • Principle of 21 CFR 210/211 and ICH Q7
  • ISO 9001:2016
  • ISO 13485:2016
  • ISO 9001:2016
  • ISO 13485:2016
  • ISO 9001:2016
  • Quality Agreements with advanced therapy medicinal products MAH and notification system
  • Change control subject to contractual
  • No change control
  • Validated for each product
  • Validated for product families
  • Validated for product families or not validated
Technology Host & Scale
  • Novel proprietary hosts that bring industrial scale enzyme batch yields and total capacity outputs
  • Conventional Research Use Only (RUO) grade hosts for small to medium scale
  • Conventional Research Use Only (RUO) grade hosts for small to medium scale
Strain/Plasmid
  • Qualified and characterized MCB/WCB
  • Optimized high level extracellular expression
  • Low efficiency expression system, intracellular expression
  • Low efficiency expression system, intracellular expression
Process
  • Inter-connected flow processes, vertically integrated layout
  • Quality control
  • Open and non-inter-connected processes
  • Open and non-inter-connected processes
Materials
  • Pharma grade, AOF, full traceability
  • Molecular biology grade (AOF for AOF products only)
  • Molecular biology grade (AOF not tracked)
Manufacturing   Facilities
  • Separate HVAC for upstream and downstream facilities
  • Qualified cleanrooms—upstream process (cleanroom class D), downstream purification and formulation (class C)
  • Animal origin-free (AOF)
  • Beta-lactam-free environment
  • HVAC systems for downstream facilities
  • Qualified cleanrooms for purification/formulation processes (class D)
  • Upstream—standard laboratories
  • Shared processes based on animal origin and beta-lactam
  • HVAC systems for downstream facilities
  • Qualified cleanrooms for purification/formulation processes (class D)
  • Upstream—standard laboratories
Equipment
  • Closed single-use system (fermenters, bags, tubing)
  • Dedicated TFF membranes, purification resins
  • Shared upstream and downstream equipment
  • Buffer exchange in open containers using standard dialysis
  • Shared upstream and downstream equipment
  • Buffer exchange in open containers using standard dialysis
Fermentation media
  • AOF rich semi-synthetic media
  • Single-use fermentation vessels
  • Steel tank, shared equipment fermentation
  • Standard complex media
  • Steel tank, shared equipment fermentation
  • Standard complex media
Purification
  • Single-use columns and resins for enzyme manufacturing
  • Dedicated columns and resins for NTP manufacturing
  • Multi-use columns and resins
  • Multi-use columns and resins
Process
  • Validated for each product
  • Validated for product families
  • Validated for product families or not validated

Table 2. TheraPure reagents portfolio for commercial applications.

In vitro transcription enzymes Nucleotides Phosphoramidites
  • Restriction enzymes
  • T7 RNA polymerase
  • Inorganic pyrophosphatase
  • DNase I
  • Capping enzymes
  • 2’-O-methyltransferease
  • Poly(A) polymerase
  • Ribonuclease inhibitor
  • T7 enzymes mix
  • NTPs (ATP, CTP, GTP and UTP)
  • Modified nucleotides (modified UTP and CTP)
  • ARCA, cap analog, and custom cap analogs
  • NTP mix
  • NTP/ARCA/cap mixes
  • DNA phosphoramidites
  • RNA phosphoramidites
  • 2’-O-methoxy-ethyl (MOE) phosphoramidites
  • 2’-O-methyl (OMe) phosphoramidites
  • 2’-Fluoro phosphoramidites
  • Dye-labeled phosphoramidites

Manufacturing scale-up to serve a global market

To better serve the growth in nucleic acid therapeutic development, we made significant investments in operational expansion with a new industrial scale manufacturing facility at our Bioscience Center of Excellence in Vilnius, Lithuania. And we’ll continue to invest so we can deliver leading innovation, support, and manufacturing capabilities to help accelerate your work.  

Purpose-built facility for IVT enzymes and nucleotides for mRNA therapeutics
Figure 1. Bioscience Center of Excellence in Vilnius, Lithuania. Certification status: ISO 9001, ISO 13485.

Expertise and support at every step of the way

Our goal is to support you at every stage of the nucleic acid therapeutic development process.  We offer integrated solutions across the workflow, custom capabilities, and the ability to scale with you as your project grows. Our skilled team from technical support staff to business development managers partner with your project team, providing the support you need to see your project to completion (including product customization, regulatory documentation, and more).

We recognize that as a critical raw material supplier, we play an important role in supporting your need for high-quality products, a stable supply chain, and robust risk mitigation strategies. Our network of manufacturing facilities enables us to supply high-quality products to our customers globally. Redundant manufacturing helps maintain that supply without interruption. Our sites are audit-ready, hosting hundreds of customer site audits per year.

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Customer service

Assistance with ordering, order status, and invoices

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Technical support

Technical assistance for all TheraPure product inquiries and selections, troubleshooting, and technical questions

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Business development manager

Help navigate regulatory processes, custom products, and service offering from research to commercialization

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