2023 Confirmed Partners
PNI is a global leader in ushering in the next wave of genetic medicines in infectious diseases, cancer, and rare diseases. We work with the world’s leading drug developers to understand disease and create the therapeutics and vaccines that will define the future of medicine. PNI offers proprietary technology platforms and comprehensive expertise to enable researchers to translate disease biology insights into non-viral genetic medicines.
WuXi STA, a subsidiary of WuXi AppTec, is a leading CRDMO providing integrated CMC services including both API and drug product for small molecule, oligonucleotide, peptide and complex conjugate from discovery to development and commercial manufacturing.
We have 14 R&D and manufacturing sites across Asia, North America and Europe. Our integrated Lipid Nanoparticle (LNP) platform features novel multi-channel mixing n-port technology that provides lipid nanoparticles with various assembly structures. We support LNP formulation development and GMP manufacturing coupled with our injectable manufacturing platform.
Providing innovative platforms for particle production used to advance medicines & therapeutics. A new company spun out of Dolomite Microfluidics building on 20 years’ experience of creating cutting-edge products - we pave the way for particle perfection. Our innovative particle technology enables you to formulate faster, be ready for your next breakthrough, and scale up your discoveries.
Founded in 2019, Arranta Bio is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled expertise are crucial for advancing products from development to commercial launch. Arranta Bio continues to expand capacity and development and manufacturing services across two sites with three distinct technology platforms designed to meet the evolving demands of our clients and partners.
Catalent Biologics provides advanced technologies and solutions for protein and gene therapy development, manufacturing and clinical supply. With technology platforms including GPEx® cell line engineering, SMARTag® bioconjugation and AAV viral vector expression combined with comprehensive analytical services and fill/finish supply, Catalent Biologics is your premier partner for clinical and commercial success.
Wacker Wacker is a full-service contract manufacturer of messenger ribonucleic acid (mRNA), plasmid DNA (pDNA), therapeutic proteins, live microbial products, and vaccines based on microbial systems. Wacker Biotech’s mRNA portfolio includes production of pDNA as starting material for mRNA, production of mRNA as well as LNP formulation in one hand (one-stop-shop) with a fully equipped, stocked and dedicated facility to produce GMP-grade mRNA to meet the highest quality standards and regulatory compliance. The production plants in Jena, Halle and Amsterdam are FDA- and EMA-certified.
MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. With our broad portfolio of best-in-class products, our CDMO capabilities, a wide range of services and our regulatory expertise we can support all stages of mRNA manufacturing including LNP formulation through Exelead® CDMO services
NOF CORPORATION is the leading commercial supplier of GMP grade activated PEGs, lipids and ultrapure Polysorbates 80 for drug delivery products through R&D to commercial scale. We provide a wide range of lipids (ionizable, PEG, and phospho) for lipid nanoparticle formulations (LNP). Our LNP platform, containing our ionizable lipid (COATSOME® SS Series), has excellent endosomal escape ability and provides high gene expression with low toxicity. It is capable of applying to gene delivery, gene editing, and RNA vaccine application under this platform.
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Emergent CDMO has the scientific and regulatory compliance experience, end-to-end development and manufacturing expertise, and efficient technology transfer capabilities that can harness the urgency, acuity, and scalability required to bring life-saving, life-extending products to market. As an integrated CDMO with the experience of an established biopharmaceutical company, Emergent stands ready to help reach your next clinical or commercial drug product milestone.
NanoFCM designs advanced analytical instrumentation allowing the measurement of biological and synthetic substrates, such as lipid nanoparticles, extracellular vesicles and viruses. The NanoAnalyzer platform offers a flexible, high throughput solution to for the single-particle, multiparameter characterisation of novel nano-sized therapeutics using nano-flow cytometry. By measuring simultaneously physical size, concentration and therapeutic content, the NanoAnalyzer can assess the encapsulation rate of API in individual nanoparticles, speeding-up development, approval and quality control of novel drugs and vaccines.
KNAUER are a berlin-based manufacturer of high-tech scientific instruments, whose strength lies in liquid engineering.
KNAUER manufactures systems for the production of lipid nanoparticle-based formulations, such as mRNA vaccines. Their NanoProducer units, which use KNAUER’s Impingement Jets Mixing (IJM) technology, are used worldwide in the high-volume production of mRNA COVID-19 vaccines.
Their latest LNP system, the NanoScaler, is designed specifically for the pre-scale up R&D of new mRNA therapies.
Think LNP. Think KNAUER.
Advanced Instruments is a global company offering a novel portfolio of analytical tools including, OsmoTECH®, a robust line of micro-osmometers to support bioprocessing and quality control (QC), and Solentim®, a portfolio of best in class imaging and single-cell deposition technologies for cell line development workflows and assurance of clonality for regulatory bodies. Advanced Instruments helps drive fast, consistent and reliable decision making throughout bioprocessing workflows empowering the development & manufacture of biotherapeutics.
Designed using QbD principles, Micropore offers a seamlessly scalable LNP manufacturing solution from around 50 micrograms for initial product characterization, all the way up to 1,000 Litres/hour for full scale production. Zero mRNA degradation is a key attribute of this low-pressure process.
Using a single geometry, the combination of tunable size, size distribution together with PAT integration assures our clients that anything they develop at the smallest scale can be transferred into manufacturing at speed and with ease. Micropore is sufficiently confident in its solution that it offers process guarantees.
Ardena is a pharmaceutical CDMO that guides companies through the drug discovery and development process to help create effective and compliant drug substance and products for clinical trials. Ardena provides you with an integrated service offering including solid state chemistry, API & nanomedicines development and manufacturing, analytical & formulation development, drug product manufacturing, bioanalytical, drug discovery and dossier development services.
Here’s the deal. We’re all about helping biologics and gene therapy researchers break free from tools that just don’t cut it. Unleashing problem-tackling products that make a huge difference in the real science they do every day. That’s our mantra, our promise and we own it.
Having a clear picture of nanomedicine formulations, like vaccine, gene, and drug delivery vehicles can mitigate the risk for unexpected complications. CryoEM simultaneously assesses drug encapsulation, morphology, lamellarity, impurities, integrity, and aggregation, and is a powerful, orthogonal technique in any analytical toolkit. NIS provides rapid, flexible and cost-effective access to cryoEM with expert knowledge and established infrastructure to accelerate projects and gain a better understanding of your formulations.
Helix Biotech is a Customer and Quality focused CDMO specializing in LNPs, Liposomes, and Hybrid Nanoparticles. Browse our selection of innovative tools and reagent systems, or reach out to us for assistance with your pre-clinical or clinical stage development, manufacturing, and analytical project.
eTheRNA manufacturing, a specialist RNA process developer and manufacturing part of the eTheRNA company offers RNA manufacture and LNP formulation. As an experienced RNA CDMO we now offer our expertise and capabilities to bring your RNA-based research and products from the lab to the clinic. We also offer you a bespoke LNP formulation development and production service, tailored to deliver your drug substance to your target organ or tissue with superior preclinical efficacy compared to currently available formulations. Our LNP formulation service is designed to support discovery and early pre-clinical development projects.
Avanti Polar Lipids
As the Lipid Technology platform of Croda Pharma, Avanti is focused on developing innovative lipid-based products of unparalleled purity to address specific medical challenges not resolved by current technology or drug products. For over 30 years, Avanti has been working with the pharmaceutical and diagnostic industries to provide solutions that save or improve lives. The past decade, we have concentrated on developing lipid components used in Lipid Nanoparticle (LNP) delivery technology to solve stability and delivery issues associated with mRNA-based vaccines and therapeutics, as well as gene editing technology. People do amazing things with our lipids. What will you do?
Since its foundation in 1977, Lipoid has gained an outstanding reputation in the development and industrial production of high-quality lecithin, phospholipids, and other lipid products, meeting the high standards of the pharmaceutical industry. Lipoid is the world’s leading company for the production and supply of a wide range of natural and synthetic phospholipid excipients on an industrial scale.
Certest Biotec, a company established in Spain in 2002 as an innovative and technology-based company, has always based its growth on the research and development of new products for diagnostics and therapeutics.
Its pharmacologic division, Certest Pharma, is dedicated to building a platform for the development of RNA vaccines and therapeutics, with a special focus on seeking improved formulations to enhance delivery.
In that sense, Certest Pharma is specialized in the development of raw materials, amongst which lipids and more specifically, ionizable lipids, are one of the leading products showing excellent in vivo performance when compared with gold standards.
Additionally, Certest Pharma offers in-house developed LNP formulations with outstanding delivery efficiency and high stabilityat 4 ºC, after lyophilization.
T&T Scientific is an all-inclusive pharmaceutical services and biotechnology company. T&T’s scalable, high-quality, and low-cost manufacturing platform produces precise, high throughput, and quality-controlled therapeutic nanomedicines and vaccines. The services include formulating, developing, and cGMP manufacturing from preclinical to commercial stages of nanoparticle-based drug products with various APIs ranging from microliters to more than 100 liter batches. T&T has clients and partnerships in over 50 countries, with a customer-centric and exceptional talent development culture to effectively create the forthcoming personalized and translational medicine platform.
InProcess-LSP is a highly innovative organization providing full Process Analytical Technology (PAT) method and instrument development services. It was founded in 2014 and is based at Pivot Park High Tech Pharma campus in The Netherlands.
Being experts in nanoparticle size characterization, they are the inventors of the NanoFlowSizer: a unique, non-invasive nanoparticle size instrumentation for real-time measurement. Nanoparticle sizing takes place within seconds, enabling continuous real-time in flow analysis.
The NanoFlowSizer is the only instrument capable of measuring particle size and size distribution of turbid nanosuspensions in flow, without the need for sample treatment.
Partner with Cayman and utilize 42 years’ experience in synthesis, purification, and characterization of lipids. Cayman manufactures an expansive selection of high-purity lipids utilized in LNP and liposome development including commercial and custom phospholipids, cationic and, anionic lipids. Our client-focused services include custom synthesis, purification, characterization, and custom API manufacturing. We couple your vision with our expertise to match your payload with the world’s best lipids and lipid chemists.
Phosphorex is a leading provider of drug delivery technologies and solutions. By harnessing the potential of microspheres and nanoparticles for drug delivery, Phosphorex offers tailored solutions and enabling technologies to optimize a drug's release rate, targeting ability, bioavailability, and deliverability, with the goal of achieving desired therapeutic effects while reducing adverse clinical outcomes. Phosphorex supports pharmaceutical and biotech companies through all phases of their development, from proof of concept to clinical studies. Phosphorex's mission is to help our partners solve complex problems and develop successful drugs to help patients. Additional information about Phosphorex is available at www.phosphorex.com.
Polysciences is a Pennsylvania based company with over 60 years of operation. We provide a nexus of technical operations and scientific laboratories housing custom synthesis, contract manufacturing and packaging and laboratory products. More specifically, Polysciences manufactures a broad array of transfection reagents and lipids to support your lipid-based delivery system, mRNA vaccine or biotherapeutics program from discovery through GMP production.
When you can make the invisible visible, you make the impossible possible. Malvern Panalytical is the leading supplier of innovative chemical, biophysical and structural characterization solutions along with drug discovery, development, and research services. Our knowledge and expertise address the analytical challenges in this field, delivering tangible economic impact.
FUJIFILM Corporation is transforming into a healthcare company through leveraging fine-chemical technologies cultivated in photo-films’ manufacturing, such as organic-chemistry and nanotechnologies. Based on these assets, we have started one-stop CDMO service from bench top formulation research to GMP manufacturing for lipid nanoparticles utilizing Fujifilm's proprietary ionizable lipids.
SCIEX delivers solutions for the precision detection and quantification of molecules, empowering our customers to protect and advance the wellness and safety of all. Today, as part of the Danaher family of global life science and technology innovators, we continue to pioneer robust solutions in mass spectrometry and capillary electrophoresis.
That’s why thousands of life science experts around the world choose SCIEX to get the answers they can trust to better inform critical decisions that positively impact lives.
PreciGenome LLC is located in the heart of Silicon Valley, San Jose, California, USA.
We have been focusing on developing nanoparticle synthesis systems based on our microfluidic platforms and solutions. Our NanoGenerator™ range includes high-performance instruments for nanoparticle synthesis for lipid nanoparticle formulation and manufacturing.
We also provide microfluidic control systems, cost-effective custom design, and OEM solutions for lipid nanoparticle synthesis, PCR instruments, and assay. Our technology enables rapid prototyping with high quality and reliable performance.
Curapath provides unmatched technical and analytical expertise in the custom design, development, and end-to-end GMP manufacture of polymer and lipid-based drug delivery systems to support cell therapy, gene therapy, and vaccine delivery. Our expertise in functional polymer and lipid excipients, formulation, and manufacturing of nanoparticles make Curapath the right partner to drive your therapeutic development. We deliver consultative, hands-on guidance from preclinical development through commercial-scale GMP manufacturing. Curapath is a knowledgeable partner you can trust to move fast, manufacture smart, and provide support through your drug development journey, accelerating your speed to the clinic. We help our partners solve even the most complex drug delivery challenges.
Resilience is a first-of-kind technology company dedicated to broadening access to complex medicines and to protecting biopharmaceutical supply chains against disruption. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end biomanufacturing solutions to help ensure the medicines of today and tomorrow can be made quickly, safely and at scale to meet patient needs. We provide solutions across five key modalities: Nucleic Acids, Cell Therapy, Gene Therapy, Vaccines & Biologics. Our non-viral nucleic acid therapeutics business model aims to help you save time and manufacturing cost by providing access to world-class expertise and modular biomanufacturing capabilities at all scales.
Micro&Nano Biologics Co.,LTD. was formally established in early 2020 when founded in 2018. Micro & Nano is a company focusing on providing integrated solutions for the development of nano delivery of genomic medicines and has acquired more than 20 invention patents (PCT included) in related field.
Micro & Nano has built the first integrated nucleic acid delivery process equipment R&D and production center in Shanghai, which can provide process and customization support to customers. The company is now focusing on RNA drug delivery equipment (laboratory to cGMP production) and process development, production, manufacturing, and has served more than 200 head pharmaceutical companies and research institutes at home and abroad, which has helped many customers to obtain IND clinical approvals for nucleic acid drugs in China, the United States, Brazil, Australia, etc.
Levitronix® is the worldwide leader in magnetically levitated bearingless motor technology, specializing in supplying process equipment for Biotech, Microelectronics and Industrial Applications. Levitronix’ products range from pump systems, mixers, flow control systems and blowers to flow sensors and viscometers.
Novel, targeted ways to treat diseases like gene therapy, DNA and mRNA vaccines, exosomes, and stem cells imply new manufacturing challenges. Dealing with very shear sensitive particles like cells, LNPs or viral vectors, especially in a continuous, sterile, or single-use processes, relate to new process equipment requirements. Levitronix® process equipment is intended to handle demanding fluid applications ensuring the highest product yields. Levitronix® PuraLev® pumps are ultra-low shear and pulsation-free by design, minimizing particle degradation or aggregation. Levitronix® LEVIFLOW® flow sensors ensure high-precision flow measurement.
Levitronix pulsation free, high-precision flow control systems make it the perfect fit for (m)RNA / lipid mixing systems for LNP formulation applications.
Sinopeg is a high-tech technology company integrating professional R&D, production and sales, the company is mainly delicate to drug delivery system (DDS) and innovative medical materials. Founded in 2011, we devote ourselves to researching and producing high quality PEG derivatives, Block Copolymers, GLP-1 intermediates, LNPs, GalNAc conjugates, ADC and ProTAC linkers, etc. Sinopeg owns 26 Intellectual Properties and 25 pending Intellectual Properties, and achieves 11 DMFs which are in compliance with FDA's standards. Our facility is ISO9001 and ISO13485 certified and is operating according to ICH Q7A GMP guidelines to produce products for pharmaceutical application.
We are an mRNA CDMO passionate about channeling our technology and the hard work of our team to democratize mRNA R&D by making mRNA readily available to more researchers and companies. We believe that science matters more than ever and that mRNA will open many more doors for science to change the lives of humans everywhere. To fulfill this vision, Vernal is committed to increasing access to high-quality mRNA.