Accelerate each step of your mRNA development
We understand the importance of accelerating the development of mRNA vaccines and therapeutics, and we are here to support you every step of the way. At Thermo Fisher Scientific, we offer a range of high-performance products and professional support to help you transform your plasmid DNA template and mRNA production processes. Our team of specialists will work with you to develop effective plasmid DNA templates and mRNA production strategies that meet critical process, scale, quality, and regulatory requirements. Our goal is to help you expedite the commercialization of your mRNA programs and bring them to market quickly, safely, and efficiently.
Plasmid production
Plasmids serve as the essential building blocks for manufacturing mRNA therapeutics. The plasmid production process involves the fermentation of bacterial cells to produce the plasmid DNA, isolating and purifying the plasmid DNA, characterizing its quality, and quantifying the final product. This high-quality plasmid DNA can then be linearized and used as the template for mRNA synthesis. Our product solutions are designed to scale up the plasmid production from development to commercial phase.
The fermentation process is a key step in producing plasmid DNA involving the growth and replication of bacterial cells harboring the plasmid DNA. It requires careful optimization of culture conditions and induction strategies to achieve high yields of high-quality plasmid DNA.
Browse through our products designed to help with E. coli fermentation:
Purpose-built to pioneer the single-use technology market by delivering a rigorous solution for microbial fermentation applications while offering the flexibility, ease of use, and efficiency found in single-use systems.
Chemically defined, animal origin free (AOF), dry powder medium designed to support high cell density cultures of Escherichia coli.
We offer an extensive portfolio of nutritionally diverse animal-origin (AO) and animal-origin-free (AOF) peptones for a variety of microbial cultures.
Gibco Water for Injection (WFI) for Cell Culture is high-quality water for use as a solvent in the preparation of cell culture media, laboratory reagents, buffers, and bioprocess liquids.
Alkaline lysis is a method used to extract plasmid DNA from bacterial cells. It involves the use of a high pH solution to denature the cell membranes and release the plasmid DNA, which can then be purified and used in downstream applications such as mRNA manufacturing. The products featured below, along with our extensive line of bioprocess containers, are here to help you streamline your harvest and lysis steps.
CentriPAK BioProcess Container chambers, manifold, labtainer (sterilized) with the connection. Designed for use in the Sorvall BIOS 16 Bioprocessing Centrifuge and 6 x 2,000 mL or 8 x 2,000 mL Swing Bucket Rotor.
The Sorvall BIOS 16 centrifuge is designed for high-quality harvesting, separation, and purification bioprocessing methods that require run-to-run reproducibility and traceability. With an enhanced capacity of up to 16 L of sample volume, a compact footprint, and innovative features to optimize operations, maximizing productivity and efficiency is simplified.
The imPULSE Single-Use Mixer (S.U.M.) can be utilized for many bioprocess mixing applications. The imPULSE design features include innovative disc mixing technology, configurable high-end controls, and monitors to fit specific process requirements. These features all enable uniform, superior mixing—scalable from 30 L to 5,000 L.
Our Process Liquid Preparation Services can help simplify your weigh-dispense-hydration (formulation) workflow for process liquid and buffer manufacturing by leveraging ready-to-hydrate (trusted-weight dry powders) and ready-to-use (pre-made liquids) chemicals.
Buffer exchange and plasmid DNA (pDNA) purification are essential steps in the production of high-quality pDNA for mRNA manufacturing. This process involves the removal of unwanted salts, contaminants, and impurities from the plasmid DNA sample.
The following products are designed to help with buffer exchange and plasmid purification:
- Thermo Scientific Hyperforma DS300 Single-Use Mixer
- BioProcess containers (BPCs)
The DynaChrom Single-Use Chromatography System offers a wide range of flow rates and process volumes, making it a highly versatile and efficient choice for customers working in pilot to scale-up operations.
Ideally suited for the purification of larger molecules such as plasmids, the POROS XQ resin is a next–generation, high-capacity, high-resolution, salt–tolerant, strong anion exchange resin that enables >140 mg/mL dynamic binding capacity in the presence of up to 6.6 mS/cm NaCl, while delivering exceptional separation performance.
The POROS HIC resin utilizes a novel coating procedure for functionalization with unique hydrophobic ligands, making it suitable for bind/elute and flow-through applications at lower salt concentrations and with higher binding capacity and resolution than classical HIC resins.
Gibco Process Liquids are designed to help streamline in-house hydration processes associated with buffer preparation and to alleviate storage challenges. These solutions are cGMP-manufactured, comply with multi-compendial specifications, and come in a variety of package sizes.
Plasmid DNA (pDNA) analytical testing involves a range of methods to assess the quality and purity of pDNA samples intended for use in mRNA manufacturing, including residual host DNA quantitation.
High-throughput, automated approaches offer the advantage of quickly processing many samples, with a high degree of reproducibility and is easily adaptable to a 96-well plate format.
The AccuSEQ Real-Time PCR Detection Software is designed to work with the 7500 Fast Real-Time PCR instrument and the SEQ family of analytical detection and quantitation assays. Security, audit, and signature capabilities help enable 21 CFR compliance.
The resDNASEQ system is a fully integrated assay leveraging real-time PCR technology for the quantitation of residual host cell DNA with a qualified DNA reference standard. This established GMP-compliant solution is widely adopted for routine use in major global biopharma companies.
mRNA production
mRNA production is a multi-step process that involves several critical stages, including in vitro transcription, purification, analytical testing, encapsulation and formulation, and fill and finish. These steps are essential for the successful development and manufacturing of mRNA-based therapeutics.
mRNA synthesis in a bioreactor involves the enzymatic transcription of a DNA template into mRNA, typically using RNA polymerases, within a controlled and optimized environment. This scalable process allows to produce large quantities of mRNA with high efficiency, enabling the development and manufacturing of mRNA-based therapeutics at a commercial scale.
The following offerings are designed to help you with in vitro transcription:
Offering easy operation and rapid assembly with the highest standards of materials and surface finish, available in 1, 3, 7, and 15 L sizes.
The HyPerforma Rocker Bioreactor is controlled by a HyPerforma G3Lab Controller and TruBio software, and is compatible with a 10 L, 20 L, or 50 L Thermo Scientific Rock-it BioProcess Container (BPC), allowing from 5 L to 25 L of working volume.
This HyPerforma DynaDrive S.U.B. and its cube-shaped tank and stirred-tank design utilize a novel drive train with multiple impellers. The mixing capability of the bioreactor is superior, which enables optimal mixing in working volumes from 5 L to 50 L.
Providing easy process scale-up or scale-down and the configurability to modify control strategies along with your process.
After mRNA synthesis, purification is performed to remove impurities such as residual template DNA, enzymes, and other contaminants. Various purification methods, such as affinity chromatography and the polish step, can be employed to achieve high purity and yield of the mRNA.
The following products and services are designed to optimize your buffer exchange and purification processes:
POROS Oligo (dT)25 Affinity Resin selectively captures mRNA via the polyadenylated (polyA) tail using simple salt and water purification steps, contributing to its ideal use in the purification and isolation of mRNA from in vitro transcription (IVT) manufacturing processes.
A cost-effective docking station solution, consisting of a mixing station and a plastic support container that holds a BioProcess Container (BPC) or tank liners. Optional dollies are available to maneuver the support containers.
Gibco Process Liquids are designed to help streamline in-house hydration processes associated with buffer preparation and to alleviate storage challenges. These solutions are cGMP-manufactured, comply with multi-compendial specifications, and come in a variety of package sizes.
mRNA drug substance analytical testing involves a range of methods to assess the quality and purity of mRNA samples intended for use in the mRNA encapsulation process including residual host DNA quantitation and residual plasmid template detection.
Designed to quantitate residual plasmid DNA with any common alleles of KanR genes in bioproduction.
The MicroSEQ Rapid Microbial Identification System is ideal for environmental monitoring, contamination investigation, root cause analysis, raw materials testing, and microbial identification.
The final steps in the mRNA manufacturing process are formulation and fill finish, where the encapsulated mRNA is filled into vials or other suitable containers, followed by sealing and labeling. This step requires strict adherence to cGMP guidelines to ensure product sterility, accuracy, and consistency.
Leverage our products and services for your mRNA encapsulation, formulation, and fill finish needs:
Thermo Scientific Bioprocess Containers (BPCs) and transfer assemblies are ready-to-use, single-use flexible containment systems for critical sterile liquid handling applications in the biopharmaceutical industry. Available from 50 mL to 3,000 L volumes.
Designed for a range of upstream and downstream applications—media and buffer preparation to biomass re-suspension and lysis process.
Our access to a global network of suppliers ensures a comprehensive portfolio that covers all chemical categories across the bioprocessing workflow and addresses any needs specific to a project or product development.
Customizable and engineered-to-order, the Fill Finish Solution helps provide outstanding integrity assurance, excellent lead times, and a range of easy-to-use, single-use consumables for compounding, final filtration, and final fill applications to enable high product quality while optimizing your workflow.
The Labtainer Pro BPC is a versatile product for high-value liquid-handling applications. With design flexibility throughout the portfolio, you can trust our high-quality films to help eliminate leaks and provide reliable liquid containment solutions from 50 mL to 20 L.
Process liquid preparation, transfer, and storage solutions
The mRNA workflow involves several critical steps, including biomass lysis, purification, and encapsulation, which require the use of buffers and solutions. We offer a range of products to help facilitate your production processes, such as mixers and storage containers, bioprocess containers, and platinum clean bottles, as well as our process liquids and chemical services.
Leverage our diverse portfolio of mixing and storage solutions for your bioprocessing workflow needs. We offer a broad range of bioprocess containers, powdertainers, and fluid transfer assemblies to suit your production processes.
Designed for a range of upstream and downstream applications—media and buffer preparation to biomass re-suspension and lysis process. The complete line of HyPerforma S.U.M.s includes 50, 100, 200, 500, 1,000, and 2,000 L sizes.
Our portfolio of plastic outer support containers includes rigid plastic vessels to support our BPC products to help meet your large-volume liquid storage, handling, and shipping needs.
These production tanks are economical alternatives to stainless-steel tanks. Designed for use in closed and open systems, they are an excellent choice for reagent storage, aseptic mixing/re-hydration, and dispensing, as well as waste management.
The Powdertainer BPC is specifically designed for powder containment and discharge applications and maintains a closed system for maximum recovery of powder while minimizing the risk of cross-contamination.
Rigid liquid containment solutions offer a reliable and secure means of storing and transporting liquids, ensuring spill prevention and containment. With their durable construction and leak-proof design, these solutions provide peace of mind and cost savings by reducing the risk of product loss, environmental damage, and regulatory non-compliance. In addition, we offer critical environmental containers in a variety of sizes, specially prepared to meet endotoxin levels of <0.06 EU/mL.
Thermo Scientific Nalgene Certified Clean and Certified Platinum Clean low and ultralow particulate bottles and carboys help to reduce the risk of potential carry-over contamination. Available in PC, PETG, and HDPE, low and ultralow particulate, and in volumes ranging from 5 mL to 20 L.
Additional considerations should be made for critical applications, including upporting documentation, choices, and designs sensitive to the necessary cleaning validations.
Leverage our Production Chemicals and Sourcing Services and Process Liquid Preparation Services to guide you in every step of your workflow.
Gibco Process Liquids are designed to help streamline in-house hydration processes associated with buffer preparation and to alleviate storage challenges. These solutions are cGMP-manufactured, comply with multi-compendial specifications, and come in a variety of package sizes.
Our access to a global network of suppliers ensures a comprehensive portfolio that covers all chemical categories across the bioprocessing workflow and addresses any needs specific to a project or product development.
Additional resources
Enhance your bioprocessing knowledge with educational content to help you understand issues, solve problems, and make solid decisions.
Deep dive into a targeted collection of scientific application notes, case studies, posters, white papers and more for bioprocessing.
Learn, evaluate, connect.
Connect with a Bioprocessing representative or request more info.
Thermo Fisher Bioprocessing Portfolio
For Research Use or Further Manufacturing. Not for use in diagnostic procedures.