2023 Sponsors
Please find all available sponsorship options for the 2023 Conference here:
Gold Sponsors
Founded in February 2009 – Vancouver, Canada-based Acuitas Therapeutics is a private biotechnology company that specializes in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles (LNP). Acuitas partners with pharmaceutical and biotechnology companies and academic institutes to advance nucleic acid therapeutics to the clinic and to the marketplace. The company’s LNP have emerged as a highly effective delivery system, first approved for patients in ONPATTRO® with partner Alnylam Pharmaceuticals and, most recently, in the Pfizer/BioNTech COVID-19 vaccine COMIRNATY®.
Aldevron serves the biotechnology industry with custom production of nucleic acids, proteins, and antibodies. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from discovery research to clinical trials to commercial applications. These products are critical raw materials and key components in commercially available drugs and medical devices.
Aldevron is known for inventing the GMP-Source® quality system and for specializing in cGMP manufacturing, operating the world’s largest facility at its company headquarters in Fargo, North Dakota, with additional facilities in Madison, Wisconsin, and Lincoln, Nebraska.
Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a global late-stage clinical mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR™ mRNA Technology (samRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat ornithine transcarbamylase deficiency and cystic fibrosis, along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (patents and patent applications issued in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on Twitter and LinkedIn.
CureVac (Nasdaq: CVAC) is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing, optimizing, and manufacturing this versatile biological molecule for medical purposes. The principle of CureVac’s proprietary technology is the use of optimized mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. In July 2020, CureVac entered in a collaboration with GSK to jointly develop new products in prophylactic vaccines for infectious diseases based on CureVac’s second-generation mRNA technology. This collaboration was later extended to the development of second-generation COVID-19 vaccine candidates, and modified mRNA vaccine technologies. Based on its proprietary technology, CureVac has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac N.V. has its headquarters in Tübingen, Germany, and has more than 1,100 employees across its sites in Germany, the Netherlands, Belgium, Switzerland and the U.S. Further information can be found at www.curevac.com.
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID pandemic.
Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.
NanoVation Therapeutics (NTx) develops customized nucleic acid and lipid nanoparticle technologies to empower its partners’ genetic medicines. By enabling the safe and efficacious delivery of nucleic acids to a variety of tissues, NTx’s unique toolbox can rapidly advance therapeutic concepts into clinical reality. NTx is delivering tomorrow’s genetic medicines, TODAY.
Polymun Scientific GmbH
is a private Austrian company, located in Klosterneuburg, offering contract development and manufacturing of biopharmaceuticals as well as development and production of LNP and liposomal formulations. Its patented liposome/LNP technology allows efficient manufacturing of constantly high quality in small and large scale. Over the last 15 years, Polymun has guided LNP and liposomal formulations into clinical trials, amongst them DNA and different kinds of RNA formulations. A prominent example is Polymun’s contribution to the BioNTech/Pfizer Covid-19 vaccine. Here the team at Polymun Scientific has significantly contributed to the 1st successful mRNA vaccine Comirnaty by optimizing and up-scaling the LNP process as well as by supporting clinical and early market supply.
Polymun is an FDA- and EMA-inspected manufacturer conducting several own R&D projects. For more information, please visit www.polymun.com
Synthgene Biotechnology Co., Ltd. is a company that provides materials and services to support mRNA and oligonucleotide manufacturing. Founded in 2018 by a group of passionate nucleic acid chemists, the goal of the company is to debottleneck the raw material supply and develop innovative solutions to support customers in the industry. The company has a robust quality system and ISO9001 certification to support cGMP manufacturing of mRNA raw materials that include NTPs, modified NTPs and cap analogs. For the GMP raw materials, Drug Master Files have been filed with FDA. In addition, Synthgene offers analytical development service and mRNA-related impurity standards and detection kits, LNP screening service, IVT process development and IVT kits for mRNA research. For solid-phase DNA and RNA synthesis, Synthgene offers high quality phosphonamidites to support cGMP oligo manufacturing. With over 200 people in R&D and AI-assisted discovery platform, Synthgene will continue to bring new products to the market.
TriLink BioTechnologies, a Maravai LifeSciences company, is helping to realize the power and potential of mRNA. As a global leader in nucleic acid and mRNA solutions for more than 25 years, TriLink delivers unrivaled chemical and biological experience, CDMO services, and high-quality readymade and custom materials, including its proprietary CleanCap® mRNA capping technology. Pharmaceutical leaders, biotech disruptors and world governments depend on TriLink to meet their greatest challenges, from delivering the COVID-19 vaccine at warp speed, to empowering innovative treatments in oncology, infectious diseases, cardiology, and neurological disorders, to enabling future pandemic response plans.
Silver Sponsors
FUJIFILM Corporation is going to transform 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.
Quantoom Biosciences is reinventing mRNA production by developing an RNA Platform (NfinityTM) that encompasses DNA (NplifyTM) and RNA (NtensifyTM) manufacturing and formulation (NcapsulateTM), along with critical reagent supply, from small to larger scale, ideally for pre-clinical and clinical study or trial projects. We are a team of scientists, engineers and clinicians committed to solving some of the biggest DNA and RNA production challenges facing vaccines and therapeutics, by delivering greater access and autonomy to mRNA technology. Our facilities are strategically located in Belgium and France, in the heart of Europe, benefiting from an exceptional biotech ecosystem. Quantoom Biosciences is part of Univercells, a global life sciences Group with the mission of making biologics accessible to all
Recipharm’s biologics business combines the capabilities of recently acquired CDMOs Arranta Bio, GenIbet, and Vibalogics. Our expanded biologics drug development and manufacturing services encompass technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, recombinant proteins, nucleic acid-based mRNA, and plasmid DNA production.
Established in 1995, Recipharm’s manufacturing, fill-finish, and delivery-device services canvass a wide variety of drug dosage forms and modalities. Recipharm is an industry-leading CDMO with over 30 facilities and 9,000 employees globally – servicing companies that are developing small-molecules, biologics, and drug-device combinations.
Combined Therapeutics Inc. (CTx) is a private biotechnology company at the forefront of developing next-generation high value mRNA vaccines to prevent infectious diseases and treat cancer. The company’s proprietary mRNA platform has been engineered to provide exceptional safety standards, ensuring controlled biodistribution and increased specificity. By combining Multi Organ Protective (MOPCTx) binding miRNA sequences with therapeutic mRNAs, the platform facilitates the targeted expression of therapeutic proteins in specific tissues, while effectively mitigating off-target effects in organs like the heart, liver and kidneys. In its initial phase, the company is focused on developing vaccines and vaccine adjuvants for infectious diseases and oncology indications with plans to initiate clinical development in 2024. The company is based in Boston with global operations in London and Paris.
Bronze Sponsors
ARCALIS is the first Japan-based GMP compliant CDMO for mRNA-based therapeutics,
which was established in April 2021 in Kashiwanoha, Chiba, Japan.
ARCALIS is a joint-venture between AXCELEAD (an integrated drug discovery platformer curved out from Takeda research and development division) and ARCTURUS (a unique manufacturing and process technology company for mRNA drug substances and LNP formulation. ARCALIS provides seamless services for mRNA therapeutics from CMC development to GMP-manufacturing seamlessly.
The GMP factory was completed in July 2023.
The plant is capable of manufacturing drug substances for mRNA therapeutics. And we can handle bulk up to LNP processing.
Discover The Difference…..that comes with over 50 years of experience manufacturing the highest purity lipids with unmatched technical expertise. As the Nucleic Acid Delivery platform of Croda Pharma, part of the Life Science sector of Croda Inc., Avanti is primarily focused on developing innovative lipid-based products and delivery systems to address specific medical challenges that are not resolved by current technology or drug products. Over the past decade, we have concentrated on developing the lipid components used in Lipid Nanoparticle (LNP) delivery technology to solve the stability and delivery issues associated with mRNA-based vaccines and therapeutics, as well as gene editing technology. In order to provide solutions that save or improve lives, Avanti uses only the finest precursors and reagents and our highly trained staff utilize proven methods and procedures to ensure the quality of the final product. Each product is certified by our analytical and regulatory specialists according to a rigorous set of specifications. People do amazing things with our lipids. What will you do?
Certest Biotec, founded in 2002, is a pioneering Spanish tech company, thriving through innovation and market exploration.
Certest Pharma, our RNA and oligonucleotide therapeutics arm, excels in delivery, focusing on ionizable lipids crucial for LNP production.
Certest Pharma’s core pillars:
Delivery Technology: Our advanced ionizable lipids ensure precise RNA delivery. We’ve screened 1500+ lipids in vivo, offering proprietary variants and thermostable, targeted LNPs for mRNA and oligonucleotide delivery.
API Platform: With two decades of experience, we cover RNA and oligonucleotide design, development, and assessment. Proprietary UTR and codon optimization software boosts protein expression, and we’ve engineered mRNA production enzymes.
Therapeutic Products: Partnering on diverse RNA and oligonucleotide therapeutics, we’re also developing a lyophilized mRNA vaccine against Tuberculosis.
Evonik is one of the world’s leading specialty chemicals companies. Our Health Care business serves as an innovation hub to global pharmaceutical, medical device and nutraceutical companies. As a global solutions provider, we provide drug delivery technologies, excipients, API manufacturing, intermediates, and amino acids for pharmaceuticals. Our core competencies extend across chemistry, biotechnology, process engineering, and span a global network of manufacturing and lab sites.
Evonik is one of the leading CDMOs for complex parenteral drug products, such as LNP formulations for mRNA delivery, gene therapies and nanomedicines. Services include the formulation, process development, GMP manufacturing, and aseptic filling for drugs that use lipid-based or polymeric delivery technologies.
We also offer custom manufactured GMP lipids and PhytoChol® vegetal-derived cholesterol for injectable lipid nanoparticle (LNP) formulations. Our other excipients for parenteral drugs include the market leading RESOMER® and LACTEL® portfolio of bioresorbable polymers for extended release and CMO services for proprietary excipients.
LIPEX® Flow extruders are offered for liposome manufacturing at all scales. Regardless of the stage of drug development, our expertise, technologies, high-quality sites, and strong regulatory track record can help reduce project risk and improve supply security.
Hongene Biotech Corporation was established in 2001 as a R&D organization and has since become a manufacturer with state-of-art facilities in the fields of nucleosides, nucleotides and phosphoramidites.
Having main operations in Shanghai, China at the start, today the company also has offices and laboratories in USA and Japan. Hongene supplies only the best quality products at competitive price to customers worldwide. Through collaborations with pharmaceutical diagnostic and biotechnology companies, Hongene is continuously developing new products in this area of science.
At Hongene our experts are also happy to offer custom synthesis products essential for your R&D, helping to bring your products to market more efficiently. Through continuous innovation, improvement of manufacturing technologies, the tightest quality control and devoted technical team and services, we aim to help our customers to achieve their goals efficiently and economically.
Based on 60 years of experience in the development and manufacturing of scientific instruments, KNAUER also offers custom engineering of equipment for the laboratory and for GMP production.
The company’s most recent development in this field – lipid nanoparticles (LNP) production systems – have enabled the large-scale manufacturing of mRNA-based vaccines to fight the Corona pandemic.
Traditionally, KNAUER is best known for its high-precision liquid chromatography systems (HPLC and FPLC) and related components. The systems are used to analyze samples for ingredients and impurities and determine their quantities, both in the laboratory and in process analysis. The systems can also purify value substances such as active pharmaceutical ingredients on a laboratory scale.
KNAUER’s valves, pumps, detectors, and other components are also used for tasks such as high-pressure dosing and various flow detection tasks in different applications. OEM manufacturing LC components for other suppliers is an important part of KNAUER’s business.
Eurogentec is an EU- and FDA-inspected CDMO manufacturing plasmid DNA, RNA and proteins for clinical phases and market supply. We offer process development, GMP and GMP-like manufacturing, quality control testing, and ICH stability studies.
We manufacture pDNA as API or as starting material for viral vector and mRNA production. Our experience includes plasmids between 2.5 to 16kbp up to the kg scale. Our new FastTrack service is designed to deliver the pDNA of interest in 4 months.
Eurogentec is a pioneer in producing enzymatic and chemically synthesized RNA (mRNA, samRNA, gRNA, siRNA). We manufacture at scales from 300mg to 50g, sizes from 600 to 27,000 nucleotides, for clinical and commercial phases.
With 25+ years of experience as CDMO, we have developed over 200 GMP processes and released more than 800 GMP batches, to support our clients. Eurogentec is based in Belgium and is part of the Kaneka group since 2010.
Merck is a leader in life science. We provide solutions to help you overcome your mRNA manufacturing and LNP formulation challenges. Our integrated CTDMO capabilities include the development and manufacturing of custom mRNAs, synthetic lipids, lipid nanoparticle (LNP) formulation and fill and finish. Discover how our capabilities, technical expertise and regulatory know-how can help you deliver and scale up your mRNA-based vaccines and therapeutics, accelerate time to market and mitigate risks
Microfluidics International Corporation, the manufacturer of Microfluidizer® high shear fluid processors, is a leader in the design and production of laboratory and commercial processing equipment for micro- and nano-scale material. Microfluidics delivers the highest standard for uniform nanoemulsions, cell disruption and particle size reduction. Microfluidizer® processor technology offers a proven, solvent-free method of achieving superior lipid nanoparticles with precisely controlled particle sizes and narrow distributions. Microfluidics offers a full range of processors with the capability to meet cGMP compliance. Microfluidizer® processor technology is linearly scalable ensuring that research & development results can easily be achieved on pilot and production-scale equipment. This unique top-down technology achieves repeatable results batch-to-batch, regardless of volume.
Myriade develops the VIDEODROP, an innovative nanoscale imaging technology. Based on the principle of interferometry, Videodrop makes it possible to measure the size and concentration of nanoparticles like LNPs:
• In real-time (40 s)
• In a single drop (7µL)
• Between 80 nm to 500 nm
• Within a concentration range of 1E8 to 1E10 part/m
• Without labeling
When developing new formulations, manufacturing processes, or different storage conditions, the quick and easy measurement of LNP concentration with the Videodrop enables:
– Better control of the production
– Repeatable & reliable quality control,
– Stability assessment,
– Standardization for comparative studies
By comparing particle numbers under different conditions with Videodrop, scientists can assess the impact of the process or composition on transfection activity.
Videodrop is the ideal tool to complete the analytical strategy to assess LNP quality.
New England Biolabs (NEB) is an industry leader in the discovery, production and commercialization of enzymes and reagents for molecular biology applications. Our portfolio includes products for DNA/RNA amplification, gene editing, synthetic biology, glycobiology, epigenetics, Next Generation Sequencing and RNA synthesis.
Accredited ISO13485 and able to manufacture GMP-grade enzymes for therapeutic and diagnostic applications, we offer end-to-end support from assay development to product launch with custom volumes, formats and formulations.
NEB is a privately held company based in Ipswich, USA and serves customers globally through exclusive distributors and 8 subsidiaries. NEB is a Certified B Corporation, a recognition awarded to organizations with the highest standards for social and environmental performance, transparency and accountability.
NOF CORPORATION, the leading commercial supplier of drug delivery products through R&D to commercial scale, provides activated PEGs for protein modification, single molecular PEGs for ADCs, Polysorbate 80 for formulation of biological medicines, PEG lipids and ionizable lipids for lipid nanoparticle (LNP) formulations. NOF’s LNP platform composed of COATSOME® SS Series, novel biodegradable ionizable lipid, demonstrates superior endosomal escape and provides high protein expression with extremely low systemic toxicity. The platform can be applied to gene delivery, gene editing, nucleic acid vaccine and in vitro transfection. It is capable of encapsulating pDNA, siRNA and mRNA, and delivering these to various organs and tissues. NOF’s LNP platform is becoming adopted in clinical planning by NOF collaborators.
The future of RNA medicines is today.
Orbital Therapeutics aims to enhance global health by unleashing the full potential of RNA-based medicines (excluding small interfering RNA) to treat human disease in ways that were not previously possible. The company is building a first-in-kind platform at the intersection of RNA technology, delivery methods, data science and automation to develop an expansive portfolio of medicines, initially focused in the areas of vaccines, immunomodulation, and protein replacement.
Founded by experts in the fields of genetic medicine and RNA development and delivery, Orbital has an operational structure designed to harness the ingenuity of a deep and diverse team of scientists, drug developers and business leaders.
Polyplus is a leading upstream solutions provider for advanced biologic and cell and gene therapy production from research to commercial scale. An innovator in nucleic acid delivery, the legacy portfolio features process-centric transfection reagents, kits, and support services including bioproduction industry standard, PEIpro® and FectoVIR®-AAV. Custom plasmid vector design was integrated into the offer in 2022 as a first measure to expanding the products and services portfolio to help the industry optimize process economics while meeting strict scientific and regulatory standards. Headquartered in Europe, the Polyplus team continues to grow globally with operations in the United States and Asia.
From vaccines and immunotherapies to protein replacement and cell reprogramming, interest in mRNA manufacturing has surged. Decades before the pandemic, Roche CustomBiotech has supplied nucleotides and enzymes for mRNA production. We work with many pioneering mRNA
companies to develop and manufacture needed raw material solutions. In collaboration with therapeutic manufacturers, our portfolio has evolved to meet the changing needs of the mRNA field. Always abreast with market developments, Roche CustomBiotech enables a new generation of mRNA therapeutics. Our guiding tenet is to minimize variation of products built
on our raw materials by ensuring best quality, high performance within narrow tolerances, andreliable delivery.
Remaining at the front of this fast-paced therapeutic space hinges not only on ideas and implementation, but also on speed and quality.
Your expertise is coming up with the idea and the implementation; as a long-standing global supplier, Roche CustomBiotech’s expertise in raw
materials can help you accelerate development and ensure high quality mRNA.
We help you strengthen your supply chain, ease transfers to manufacturing, secure continuous production,
and create consistently high-quality products.
https://custombiotech.roche.com/global/en/portfolio/mrna-therapeutics-raw-materials.html
Thermo Fisher Scientific supports developers and manufacturers of mRNA-based therapeutics and vaccines with a world class product portfolio that spans the end-to-end workflow from discovery through large-scale commercial production. We provide solutions and services across the manufacturing workflow including upstream, downstream, analytical, formulation, fill and finish.
Vernal Biosciences is a fully integrated CDMO with a singular focus on manufacturing and formulating mRNA. Because science matters more than ever, we are inspired to accelerate the potential of mRNA through democratizing access to our expertise and unparalleled mRNA and LNP-mRNA platform technologies. Combined with phase-appropriate GMP, and control and quality systems, these technologies are an advanced manufacturing staging ground for your research, preclinical, and ultimately clinical development supply needs.
Company Website: https://www.vernal.bio/
Wacker Biotech – Your One-Stop-Shop All the Way from pDNA to RNA including LNPs
Wacker Biotech offers not only process development and commercial manufacturing of biopharmaceuticals (therapeutic proteins, vaccines, live microbial products) based on microbial systems, but also an integrated service portfolio to produce plasmid DNA (pDNA) and messenger ribonucleic acid (mRNA) including LNP formulation. Wacker Biotech’s offerings include diverse solutions for mRNA production from pDNA supply, process development as well as transfer of mRNA based processes up to GMP manufacturing for clinical and commercial supply. Additionally, our customers benefit from our broad spectrum of LNP formulations for their mRNA-based product. Our R&D center in Munich, Germany, leverages strong know-how and experience in pDNA manufacturing, mRNA production, LNP formulation and analytical development.
For more information, visit: wacker.com/biologics
