Lead Partner

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Precision ADVANCE, a collection of interconnected services and complementary teams across Precision for Medicine, Project Farma, and Precision Value & Health are uniquely focused on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring a cell or gene therapy to market.

Since 2013, Precision ADVANCE has helped advanced therapy innovators with 50+ cell and gene therapy clinical studies, 40+ facility builds and capital expansions with $4B+ in investment and supporting 70%+ of approved cell and gene therapies on the market.

Expertise Partners

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BIA Separations

BIA Separations, a Sartorius company, develops and manufactures market-leading CIM® monolithic chromatographic columns for purification and analysis of large biomolecules, such as viruses, plasmids and mRNA, which are applied in cell and gene therapies.  BIA's technology for manufacturing-scale purification is already used in production of the first commercialized advanced therapeutics; BIA also has a keen presence with novel drug candidates in the clinical pipeline.  Expecting continued strong double-digit sales growth over the next few years, BIA earned sales revenue approx. 25 million Euros in 2020, contributing to Sartorius Bioprocess Solutions, part of the Sartorius Group.

www.biaseparations.com

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Azzur Group

Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States, we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM.

www.azzur.com

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Charles River

At Charles River our focus is always on anticipating tomorrow’s drug development needs today and this is why we have invested in the tools, talent and capacity to further the new frontier of cell and gene therapy development. We can support your cell and gene therapy programs every step of the way, from early discovery, manufacturing of viral vectors, plasmid and autologous/allogenic cells, toxicity/toxicology studies, to analytical release testing of your cell line characterization, biosafety and potency testing.

Our global footprint, team of experienced professionals and unsurpassed portfolio of integrated services are dedicated to supporting you to help get your product to patients faster.

To learn how we can help accelerate your cell and gene therapy goals, visit criver.com/CGT.

Andelyn

Andelyn Biosciences

Andelyn is pioneering solutions that turn hope into reality as a Cell and Gene Therapy CDMO. Capabilities span viral vector process and analytical development, small to large scale adherent and suspension based GMP manufacturing up to 2000L, located in Ohio, USA. Having 20+ years of experience with viral vector manufacturing, Andelyn offers access to globally recognized thought leaders with troubleshooting/characterization expertise and GMP material produced for 75+ worldwide clinical trials. In addition to producing 400+ cGMP clinical batches, Andelyn provides research and tox grade plasmids with an additional offering of GMP plasmid manufacturing (early 2022), full quality system/regulatory support and supply chain vertical integration. Our state-of-the-art 185,000 sq ft commercial manufacturing facility will expand capacity across 16+ production suites for customization of new programs and tech transferred programs as of July 2022, offering clinical through commercial-scale capabilities that will help accelerate innovative therapies to bring more treatments to more patients.

www.andelynbio.com

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AllStripes

AllStripes is a healthcare technology company dedicated to unlocking new treatments for people affected by rare diseases. AllStripes’ technology platform generates regulatory-ready evidence to accelerate rare disease research and drug development, and empowers patients and families to securely participate in treatment research online and benefit from their own medical data — at no cost to participants. AllStripes was co-founded by CEO Nancy Yu and technology developer Onno Faber, following his diagnosis with the rare disease neurofibromatosis type 2. The company is backed by Lux Capital, JAZZ Venture Partners, Spark Capital, Medidata, McKesson Ventures, Maveron, and a number of angel investors.

www.allstripes.com

Program Partners

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Precision for Medicine

Precision for Medicine is the first full-service, global clinical research organization purpose-built to accelerate precision medicine research and development. Our expertise in rare and orphan diseases includes 150+ projects in 80+ diseases. Precision converges the power of clinical operations excellence, deep laboratory expertise, and advanced data sciences to maximize insight into patient biology, deliver more predictable trial outcomes and speed clinical development.

Our gene therapy expertise is mobilized through Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of the clinical, regulatory, manufacturing and commercial requirements to successfully bring a gene therapy to market. With over 2100 people and 35 offices worldwide, we stand ready to help accelerate your life-changing treatments anywhere around the globe.

www.precisionformedicine.com

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Project Farma

We provide biomanufacturing strategy and execution to startup and established pharmaceutical companies, advanced therapy companies, academia, hospitals, government agencies, financial institutions, CROs/CMOs, not-for-profit organizations and medical device companies. Our services include turnkey capital projects, tech transfers and facility builds; owner's representation; project and program management; validation; quality, regulatory and compliance; engineering and automation; serialization / track and trace; reliability, compliance and asset management; and more. We are committed to advancing manufacturing to achieve operational excellence and accelerate speed to market for next-generation medicines.

www.projectfarma.com

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Thermo Fisher Scientific

Thermo Fisher Scientific provides industry-leading solutions for drug development, clinical trial logistics and commercial manufacturing to customers through our Patheon brand. Our Patheon Viral Vector Services business (formerly Brammer Bio) specializes in CDMO services for companies developing gene-modified cell therapies and in vivo gene therapies.Our key offerings include process and analytical development, clinical and commercial supply of viral vector drug substance and drug product, and regulatory support, enabling our clients to bring novel medicines to market.We are flexible to support every client’s unique product needs, timelines and regulatory pathways. Through recent investments in our world-class facilities and planned expansions, we are strategically positioned to support your immediate and long-term viral vector manufacturing needs.

www.patheon.com/viral-vector-services/

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Cytovance Biologics

Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule APIs from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization.  A centralized, responsive program management team coordinates all critical CMC activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support.  Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.

www.cytovance.com

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Mix Talent 

Mix Talent was built to support the near-term goals and long-term success of pharma, biotech, and gene therapy organizations. We leverage 30 years of experience in clinical and commercial executive search, sales builds, human resources, and talent assessment to anticipate your challenges and solve your complex problems, helping you grow your organization with full attention to your culture: the most powerful force for talent there is.

www.mix-talent.com

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ICON plc

ICON plc is a world-leading clinical research organization powered by healthcare intelligence. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device, and government and public health organizations. We develop new innovations, drive emerging therapies forward and improve patient lives. With headquarters in Dublin, Ireland, ICON employed approximately 37,960 employees in 159 locations in 53 countries as of September 30, 2021.

www.iconplc.com

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Optum Frontier Therapies

Creating access to therapies at the frontier of health care, Optum Frontier Therapies reimagines the specialty pharmacy experience by delivering one-stop distribution, tailored services, and data-backed clinical care and research. Our offerings ensure holistic impact for patients and their families, and support commercialization for manufacturing partners – from expertise in deep cold chain to wholesale distribution. As an independent business leveraging the best of Optum, our team is dedicated to building new models for advanced therapeutics.

www.frontiertherapies.optum.com

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Veristat

Veristat is a CRO with a focus in accelerating clients’ rare disease therapies for unmet medical needs through the clinical development process. We've worked on more than 300 rare disease clinical projects and have prepared over 35 rare disease regulatory submissions. With experience in running trials for the first gene therapy approved in Europe, and over 20 gene therapy trials, Veristat is adept in providing comprehensive solutions for Advanced Therapies.

www.veristat.com/therapeutic-expertise/rare-diseases

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Halo Labs 

Halo Labs knows stability and particles. The Aura, our flagship product, can count and characterize subvisible particles - and tell you whether they are aggregated viral capsid, or external contaminants.  A simple, plate-based approach enables low-volume (5µL), high-throughput, fully automated particle imaging and analysis at any stage from developability assessment through quality control.

www.halolabs.com

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Center for Breakthrough Medicines (CBM)

Center for Breakthrough Medicines (CBM) is an innovative cell and gene therapy focused contract development and manufacturing organization located in the heart of “Cellicon Valley.” CBM’s integrated and comprehensive service offering provides a one-source solution to accelerate speed to market for advanced therapies. A client-driven approach coupled with a patient-centric culture delivers high quality and reliable process and analytical development, viral vector manufacturing, GMP testing, cell therapy bioprocessing, plasmid production, and cell banking services for a full product’s life cycle.

www.breakthroughmedicines.com

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Certara

Certara accelerates medicines to patients using biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.  Our unique and regulatory-ready models for immunogenicity, immune-oncology, rare disease, vaccines and gene therapy are used by major pharmaceutical and emerging biotech companies.

www.certara.com

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Invitae

Invitae is bringing comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. As one of the fastest growing genetic information companies, Invitae is advancing the broad potential of genetics. The company provides genetic information services for all stages of life – from preconception screening, to newborn diagnosis, to inherited disease screening, to proactive health management – and a unique, rapidly expanding network of patients, hospital systems, and advocacy partners that is moving genetics from onedimensional testing to complex information management.

www.invitae.com/en

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Parexel

You’re on a mission to change lives. We want to help you get there.

Keeping pace with the rapidly evolving biotech environment requires the expertise to anticipate and adapt to development challenges before they happen. At Parexel Biotech, we work side-by-side with biotech companies to break down the development journey into a series of connected decisions, steps, and milestones - to get to that breakthrough innovation – from regulatory and commercial strategy to cutting-edge trial design and execution. We use our deep experience to bring you and your patients closer to better outcomes so you can get your innovation from the lab to the patients who need it most, faster. #NeverStopBioteching.

www.parexel.com

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Polyplus-transfection

Polyplus-transfection applies its 20 years expertise to the development of novel transfection solutions, especially for viral vectors manufacturing for Gene & Cell Therapy. We are proud to provide the gold standard PEIpro, as well as the novel game changer FectoVIR-AAV, specifically designed for AAV production in suspension cells. Both reagents are available at RUO and GMP-grades, making them suitable from R&D to clinical trial and commercial scale, accompanied by a strong scientific and regulatory support.

www.polyplus-transfection.com

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Trinity Life Sciences

Trinity Life Sciences is a trusted strategic commercialization partner, providing evidence-based solutions for the life sciences. With over 25 years of experience, Trinity is committed to solving clients’ most challenging problems through exceptional levels of service, powerful tools and data-driven insights. Trinity’s range of products and solutions includes industry-leading benchmarking solutions, powered by TGaS Advisors. To learn more about how Trinity is elevating life sciences and driving evidence to action, visit trinitylifesciences.com.

www.trinitylifesciences.com

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Viralgen

Viralgen is a CDMO created in 2017 to respond to the unmet need for manufacturing of gene therapies, with the goal to help broaden access to these life-saving therapeutics. We specialize in the production of rAAV viral vectors with our proprietary Pro10™ suspension manufacturing platform, enabling industry-leading scalability, reproducibility, and speed to market. Through our superior technology platform, we deliver industry-leading titers and cGMP-certified quality for all AAV serotypes to our client partners, optimizing the cost-of-goods and accelerating clinical development and commercialization of life-changing genetic medicines.

www.viralgenvc.com

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Rho

Rho is a global, privately held contract research organization (CRO) headquartered in Research Triangle Park, a biotech hub in North Carolina, US. Rho provides a full range of drug development services, from program strategy through to clinical trials and marketing applications. For more than 35 years, Rho has been a trusted partner to some of the most innovative pharmaceutical, biotechnology and medical device companies as well as academic and government organizations. Dedicated to service excellence and cross-functional collaboration, Rho’s therapeutic expertise, employee focus and commitment to strong site relationships change what it means to work with a CRO – accelerating time to market, maximizing ROI, and delivering consistent, smarter and more efficient programs. Experience Rho by following the company on Facebook, LinkedIn and Twitter.

www.rhoworld.com

Vineti

Vineti offers the first commercial, configurable cloud-based platform to expand patient access to life-saving cell and gene therapies. Vineti was co-founded by GE and the Mayo Clinic to solve the key challenges that patients, medical providers, biopharmaceutical companies, and regulators face in the delivery and commercialization of individualized therapies. Now a fully independent company, Vineti offers a digital platform of record to integrate logistics, supply chain management, manufacturing, and clinical data for personalized therapies. The Vineti Personalized Therapy Management® (PTM) platform aligns and orchestrates the advanced therapy process and improves product performance overall, supporting the full continuum of patient-specific therapies, including personalized cancer vaccines and autologous and allogeneic cell and gene therapies. Vineti is currently serving patients, healthcare providers, and researchers in hundreds of leading medical centers and manufacturing centers world-wide on behalf of a growing number of biopharmaceutical partners. The World Economic Forum has honored Vineti as a World Economic Forum Technology Pioneer. Vineti is headquartered in San Francisco, California, with teams based in the Washington, D.C. area and Yerevan, Armenia.

www.vineti.com

Accredo

Accredo is a full-service specialty pharmacy. Accredo’s Rare Therapeutic Resource Center is dedicated to the treatment of complex, rare and ultra-orphan conditions. Our comprehensive therapy management program engages condition-specific pharmacists, nurses, social workers, dieticians, reimbursement specialists and patient care managers who provide dedicated support services to patients, their families and healthcare professionals.

Learn more at accredo.com

The Jackson Laboratory

The Jackson Laboratory is a global leader in preclinical oncology studies and has been driving therapeutic development breakthroughs for over 90 years. With the most innovative preclinical platforms including humanized mice, and services such as dose ranging, toxicity, and efficacy studies, JAX empowers oncology drug developers worldwide.

www.jax.org

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Labcorp

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives.

Learn more about Labcorp at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp..

Hosting Partners

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Cytiva

Cytiva is a global life sciences leader dedicated to advancing and accelerating therapeutics. Cytiva is a trusted partner to customers that undertake life-saving activities ranging from biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients.

www.cytiva.com

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Pall Corp

Pall supports clients discovering, developing and producing pharmaceuticals, vaccines, cell and gene therapy products. Pall is the leading provider of bioprocessing, integrated automated systems and single-use solutions - from suspension and adherent cell bioreactors, through downstream purification, to formulation and filling. Process and product contract development services from cell culture through purification are offered, with extensive expertise in viral vector product development.

www.pall.com

Resilience

Despite the explosive innovation in therapeutic discovery and development, biomanufacturing innovation and platforms have not kept pace. We intend to change that.  

Resilience is a technology-based manufacturing company dedicated to broadening access to complex medicines and protecting biopharmaceutical supply chains from disruption. Founded in 2020, the Company is building a network of high-tech biomanufacturing platforms and capacity to ensure the medicines of today and tomorrow can be made at the quality, cost, and scale to meet patient needs. Resilience offers solutions for cell and gene therapy services from early clinical through commercial manufacturing including: process and analytical development, cell banking, viral vector production (AAV, LVV, and other viral vectors), immunotherapies, HSCs, iPSCs, and regenerative medicines. We are continuously advancing the science and technology of CGT biomanufacturing by investing heavily in R&D, manufacturing platforms and infrastructure. We focus on deep-rooted partnerships and novel business models. Resilience aims to free its partners’ time and resources to focus on therapeutic discoveries that improve patients’ lives and democratize access to medicines.

www.resilience.com

Panel Partners

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FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

www.fujifilmdiosynth.com 

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Deallus

Deallus is a unique strategic intelligence consultancy operating across the global life sciences sector. Our mission is simple: to prepare you for the future by delivering the forward-thinking assurance you need in an uncertain and highly competitive world. The knowledge and clarity we provide helps life sciences companies shape future markets by making the right strategic decisions with confidence.

www.deallus.com

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AGC Biologics

AGC Biologics is a global CDMO providing end-to-end pharmaceutical development and manufacturing services for protein-based biologics and cell and gene therapies. With seven facilities and teams of scientists across three continents, we have the resources and the available capacity you need to accelerate your race to GMP. From development, to clinical trials, to full-scale commercialization, we can help you reach your goals at any stage in the drug development and manufacturing process.

We specialize in the following modalities and substances, mammalian and microbial-based therapeutic proteins, recombinant DNA, plasmid DNA, viral vectors, Messenger RNA (mRNA) and genetically engineered cells. Our services range from Process Development, Analytical Development, cGMP Manufacturing, Quality Control and Quality Assurance and Process Validation.

We forge exceptionally strong partnerships with our clients and we never lose sight of our commitment to deliver reliable and compliant drug substance. Right. On Time.

www.agcbio.com

Exhibition Partners

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VGXI

VGXI, Inc. is a leading plasmid DNA CDMO with nearly 20 years of experience providing exceptional quality products to clinical trials worldwide. The company's continuous, low-shear AIRMIX® lysis technology and optimized purification process provide highly supercoiled plasmid with exceptional purity across all manufacturing scales. Production services include high purity plasmid for preclinical research, Highly Documented (HD) plasmid for GMP viral vector production or pharm/tox studies, and cGMP plasmid DNA for clinical through commercial supply.

www.vgxii.com

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emotive Agency

emotive is multi-award winning, global healthcare communications agency with offices across the EU and US. Our highly skilled, experienced team is already a trusted partner for many leading biopharma companies in ATMP and rare disorders in the pre, peri and post launch stages of the product lifecycle.

We use our strategic scientific, creative and technical expertise to engage with HCPs, those living with a disorder and other stakeholders in the care pathway to stimulate advocacy and uptake of novel and innovative products.

www.emotiveagency.com

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Premier Research

Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.

As a global company, Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

Whether it's developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.

www.premier-research.com

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ProPharma Group

ProPharma Group is the global, independent, single-source provider of regulatory and compliance consulting, clinical research services, pharmacovigilance, and medical information serving pharmaceutical, biotechnology, and medical device companies. Founded in 2001, ProPharma Group has more than 1900 colleagues worldwide providing a comprehensive portfolio of regulatory, clinical and compliance solutions to help solve complex challenges in a dynamic regulatory environment. With the mission to improve the health and safety of patients, ProPharma Group is focused on delivering the highest quality of services throughout the full product lifecycle.

www.propharmagroup.com

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QPS

QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalysis and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities.

www.qps.com

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Avid Bioservices

Avid Bioservices (NASDAQ:CDMO), an S&P SmallCap 600 company, is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biologics. The company provides a comprehensive range of process development, CGMP clinical and commercial manufacturing services for the biotechnology, biopharmaceutical, and cell & gene therapy industries. With 29 years of experience, Avid's services include CGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support.

www.avidbio.com

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Gyros Protein Technologies

Gyros Protein Technologies provides enabling peptide synthesis and bioanalytical solutions helping scientists increase biomolecule performance and productivity in pre-clinical/clinical development and bioprocess applications. The nanoliter-scale Gyrolab® immunoassay platforms and expanding portfolio of kits are used by scientists in leading pharmaceutical, biotech and CRO/CMO companies in the development and manufacturing of biotherapies including cell and gene therapies. Gyrolab immunoassays provide key workflow advantages of speed, automation, and low sample and reagent usage with a wide dynamic range in applications including PK/PD, immunogenicity, titer determination, and analysis of bioprocess-related impurities. Gyros Protein Technologies is a division of Mesa Laboratories.

www.gyrosproteintechnologies.com

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GenoSafe

GenoSafe provides analytical testing services for the evaluation of quality, safety and efficacy of Gene and Cell therapy candidates including :

  • biodistribution, shedding and immunogenicity studies on preclinical samples ;
  • QC testing, such as viral titration, safety (e.g. replication-competent viruses) and potency/efficacy testing ;
  • clinical bioanalysis of patient samples, including immunogenicity, shedding and gene expression studies.

GenoSafe brings more than 15 years of experience in the development, qualification and validation of key analytical methods for product and sample testing.

www.genosafe.com

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Cryoport Systems

Cryoport Systems is the life sciences industry’s most trusted provider of temperature-controlled supply chain solutions, serving biopharmaceutical, IVF and surrogacy and animal health organizations around the world. We are committed to simplifying and de-risking global supply chain processes through our innovative technology, nonstop monitoring and 24/7/365 support. Cryoport’s proprietary Cryoport Express® liquid nitrogen dry vapor shippers, innovative C3™ 2-8°C & CRT solution, Cryoportal® logistics management platform, leading-edge Smartpak™ condition monitoring system and geo-sensing technology paired with unparalleled temperature controlled expertise and 24/7/365 customer support, make Cryoport the end-to-end supply chain partner that you can trust. We are proudly supporting over 500 regenerative medicine clinical trials and 8 commercial cell and gene therapies.

www.cryoport.com

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EVERSANA

EVERSANA™ is the leading provider of global commercial services to the life sciences industry. Our integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. We serve more than 500 organizations, including innovative start-ups and established pharmaceutical companies to advance life science solutions for a healthier world.

To learn more about EVERSANA, visit eversana.com

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Forge Biologics

Forge Biologics is a hybrid gene therapy contract manufacturing and therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea into reality. Forge has a 175,000 ft2 facility in Columbus, Ohio, “The Hearth,” to serve as its headquarters. The Hearth is the home of a custom-designed cGMP facility dedicated to AAV viral vector manufacturing and will host end-to-end manufacturing services to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most.

www.forgebiologics.com

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G-CON

G-CON is fulfilling the needs of reliable and fast deliverable capacities for the biopharmaceutical industry. G-CON provides comprehensive prefabricated and prequalified CGMP compliant cleanroom environments and platforms for uses ranging from laboratory, clinical and commercial production for a variety of therapeutic applications.

Through a well-defined customer needs driven approach to design, production, installation and qualification, G-CON provides a fully functional cleanroom product portfolio enabling reliable biocapacity planning on-time and within-budget.

www.gconbio.com/viral-vector-cleanroom-catalog

 

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Yposkesi

Yposkesi is one of the largest Contract Development & Manufacturing Organizations (CDMO) in Europe. Dedicated to viral vector manufacturing for gene therapy, Yposkesi is a one-stop shop offering: bioprocess development (upstream and downstream processing), analytical development, small/pilot to large-scale production, cGMP manufacturing of clinical batches of lentiviral vectors and AAV (Adeno-Associated Virus) and regulatory support. Yposkesi is expanding and with a new building, will offer commercial batches production in 2023.

Through a well-defined customer needs driven approach to design, production, installation and qualification, G-CON provides a fully functional cleanroom product portfolio enabling reliable biocapacity planning on-time and within-budget.

www.biologics.catalent.com/cell-gene-therapy

 

Azenta Life Sciences

Azenta Life Sciences provides unrivaled sample exploration and management solutions to help our customers accelerate discovery, development, and delivery to bring impactful breakthroughs and therapies to market faster. We are the global leader in automated compound management for drug discovery, biological storage, and sample processing solutions. Azenta understands the importance of sample integrity and provides a comprehensive range of solutions across our leading capabilities of genomic services, sample repository services (SRS), consumables and instruments, data management and informatics, sample sourcing, and automated ultra-cold storage.

www.azenta.com

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InformedDNA

InformedDNA® is the country's leading applied genomics solutions company, helping more people harness the full power of the genomics revolution.  With the largest independent staff of board-certified genetics specialists in the U.S., InformedDNA ensures that health organizations have access to the highest quality, most current genomics insights to optimize clinical decisions. Our solutions have helped optimize the health benefits of more than 100 million covered lives and have navigated hundreds of thousands of people to the right treatments or clinical studies/trials.

Key offerings for pharmaceutical/biotech companies include design support for precision medicine clinical studies and trials, patient engagement and recruitment, physician education and engagement, clinical genetic counseling, and test ordering and interpretation services.

www.informeddna.com

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Catalent Cell & Gene Therapy

Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing to position Catalent as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global network of clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. Catalent Cell & Gene Therapy has produced more than 100 cGMP batches across 70+ clinical and commercial programs.

www.biologics.catalent.com/cell-gene-therapy

Event Partners

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Rentschler Biopharma

Rentschler ATMP was launched by Rentschler Biopharma in 2021 to provide high-quality drug substance for advanced therapy medicinal products (ATMP).

Rentschler Biopharma is a leading global CDMO, focused exclusively on client projects. Thanks to our 50 years of proven scientific expertise in biotechnology, we count ourselves among the leaders in the industry. From our headquarters in Laupheim, Germany, and our site in Milford, USA, we offer end-to-end solutions including biopharmaceutical process development and cGMP manufacturing.

At Rentschler ATMP in Stevenage, UK, we plan to partner with entrepreneurial players and enable them to transform ideas into products with the potential to treat and even cure patients with serious diseases.

www.rentschler-biopharma.com