Regulatory Sourcing Center
Regulatory challenges facing cell and gene therapy companies are both numerous and complex at every stage of the life cycle.
One look at the U.S. Food & Drug Administration website illustrates that the pathway to cell and gene therapy-related research and development is riddled with regulatory oversight. Understanding and implementing the proactive scientific and regulatory advice to medical researchers and manufacturers in novel product development is arguably the most important aspect of advanced therapies.
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Looking for help understanding Cell & Gene therapy regulations? If you're searching for information or a supplier, let Life Science Connect lend you a hand.
Advanced Instruments, Inc.
We believe that quality and productivity go hand-in-hand and have built a family of products and services to help biologics manufacturers and process developers ensure the yield, purity, and consistency of biopharmaceutical products through osmolality testing. Whether you need to maintain optimal cell growth, ensure active pharmaceutical ingredient (API) purity and yield, or confirm quality during fill and finishing while helping you remain in compliance with regulations.
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Applied Biosystems by Thermo Fisher Scientific, qPCR
When therapeutic product, viral capsid, or other vector elements may be culprits in gene therapy-induced toxicity, exploring activation or silencing of gene expression may help to guide vector design and construction to balance therapeutic efficacy against potential toxicity. Explore the importance of reproducible quantitation of gene expression to investigate potential sources of vector-induced immunotoxicity and understand well-to-well and instrument-to-instrument data concordance across multiple biosystems.
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CAI
CAI exists to help our customers design, deliver, operate, and maintain quality-critical manufacturing (GMP related) or mission-critical facilities. Our engineering, technical, and consulting services encompass all aspects of operation: equipment, automation, process, and human performance. The result is a superior level of operational performance and reliability.
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Cardinal Health
Cardinal Health Advanced Therapy Solutions offers tailored solutions that simplify and streamline complexities of cell and gene therapies (CGT). From clinical development to commercialization, our experts will partner with you every step of the way to ensure your therapy is in the hands of patients who need it most.
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Cencora
Cencora is a leading global pharmaceutical solutions organization centered on improving the lives of people and animals around the world. We partner with pharmaceutical innovators across the value chain to facilitate and optimize market access to therapies. Care providers depend on us for the secure, reliable delivery of pharmaceuticals, healthcare products, and solutions. We are united in our responsibility to create healthier futures.
Cytiva
Cytiva is a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the delivery of transformative medicines to patients. Visit cytiva.com for more.
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Danaher Life Sciences
Every day, scientists around the world are dedicated to unraveling the mysteries of disease, discovering novel therapies and vaccines, and conducting crucial drug testing. Danaher Life Sciences comprehensive capabilities go beyond research, enabling us to drive the development of innovative biopharmaceuticals, revolutionary cell and gene therapies, and other breakthrough treatments.
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Germfree
Germfree manufactures a comprehensive line of barrier systems for aseptic control and containment as well as a complete mobile and modular cGMP facilities. We offer advanced solutions to maintain cGMP processes and production for a wide range of biopharmaceutical applications. We are a single source OEM provider of complete cleanroom and lab facilities, and the corresponding integrated equipment designed an purpose-built by our leading-edge fabrication technology, engineering teams and subject-matter experts.
IPS-Integrated Project Services
IPS-Integrated Project Services is a global provider of technical consulting, architecture, engineering, project controls, construction management, and CGMP compliance services for technically complex pharmaceutical development and manufacturing facilities worldwide.
MilliporeSigma
At MilliporeSigma, our mission is to help our customers improve human health and life worldwide. This commitment means providing leading life science products and services in ways that also help improve the communities and environment in which we all live.
Novotech
Novotech is internationally recognized as the leading Asia Pacific-centered Biotech CRO with global execution capabilities. Novotech is a clinical CRO with labs, phase I facilities, drug development consulting services, and FDA regulatory expertise and has experience in over 5,000 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biotech clients conducting clinical trials in Asia Pacific, the US, and Europe.
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Pharmatech Associates - A USP Company
Pharmatech Associates is a global consultancy for the life science industry and advises U.S. and global drug sponsors and manufacturers to supply quality medicines in all major markets. Pharmatech Associates' domain expertise ranges from small molecule to cell and gene therapy, biologics, and advanced manufacturing technologies. Services to clients include regulatory strategy, compliance, and remediation to address manufacturing quality, CMC, and analytical method qualification.
Polyplus-transfection
Polyplus-transfection® SA is the leading biotechnology company that supports Gene and Cell therapy, biologics manufacturing and life science research with innovative nucleic acid transfection solutions. Polyplus-transfection's strengths are 20 years of experience in manufacturing transfection solutions with tailored scientific and regulatory support to accelerate research. Based in the Science Park close to Strasbourg (France), Polyplus-transfection offers an extensive and growing range of transfection reagents available worldwide.
Precision ADVANCE
Precision ADVANCE is a collection of interconnected services and complementary teams uniquely focus on the complexities of clinical, regulatory, manufacturing, and commercial needs to successfully bring cell or gene therapies to market. Learn more about how we accelerate clinical development with Precision for Medicine, optimize next-gen manufacturing with Project Farma and drive commercial success with Precision Value & Health.
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Sartorius
The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. The Bioprocess Solutions Division with its broad product portfolio focusing on single-use solutions helps customers to manufacture biotech medications and vaccines safely and efficiently. The Group has been annually growing by double digits on average and has been regularly expanding its portfolio by acquisitions complementary technologies.
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Veristat, Inc.
Veristat, a global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years' experience in clinical trial planning and execution, Veristat is equipped to support any development program. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last 10 years alone.
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Waters Corporation
Waters Corporation unlocks the potential of science through analytical measurement technology, deep scientific expertise, and reliable insights to enhance human health and well-being. As a global leader in analytical instruments, consumables, and software, Waters has pioneered chromatography, mass spectrometry, and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years.
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