Collaborating with Aragen allows our clients to experience a proactive and phase-appropriate approach to pharmaceutical process development and validation, coupled with access to cutting-edge technology
Technology transfer of a drug substance is a multifaceted activity with inherent technical, regulatory, and quality risks that needs to be addressed. At Aragen, we offer a proven and adaptable approach to technology transfer, whether for scale-up or transitioning to a different facility
In the development of a drug substance, the timely identification and mitigation of potential risks and hazards are critical factors that can significantly impact the overall success of the process. Failing to address these challenges promptly can lead to unsafe conditions and various negative consequences
In the development of a drug substance, the timely identification and mitigation of potential risks and hazards are critical factors that can significantly impact the overall success of the process. Failing to address these challenges promptly can lead to unsafe conditions and various negative consequences
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At Aragen, we offer comprehensive CMC (Chemistry, Manufacturing, and Controls) support for your IND application from process chemistry and drug substance manufacturing to formulation development and manufacturing.
Precision meets performance with our Analytical Testing services. Uncover the insights that drive success. Accurate, reliable, and tailored solutions for your analytical needs. Connect today to elevate your quality assurance to the next level.
At Aragen, we have a proven history of reliably developing and manufacturing high-potency APIs and compounds for our clients. This includes a diverse range such as immunosuppressants, cytostatic/protein kinase inhibitors, ultra-potent cytotoxic drug substances, drug linkers, PEG and cyclodextrin polymeric conjugations, and toxins for antibody drug conjugates (ADCs).
Collaborating with Aragen allows our clients to experience a proactive and phase-appropriate approach to pharmaceutical process development and validation, coupled with access to cutting-edge technology.
Technology transfer of a drug substance is a multifaceted activity with inherent technical, regulatory, and quality risks that needs to be addressed. At Aragen, we offer a proven and adaptable approach to technology transfer, whether for scale-up or transitioning to a different facility.
In the development of a drug substance, the timely identification and mitigation of potential risks and hazards are critical factors that can significantly impact the overall success of the process. Failing to address these challenges promptly can lead to unsafe conditions and various negative consequences
We provide an extensive technology transfer initiative aimed at implementing a reliable scale-up model, ensuring a seamless manufacturing process from clinical to commercial stages. Our collaboration with your team mitigates commercialization risks, guarantees manufacturability, and ultimately delivers high-quality
Lorem ipsum dolor sit amet, consectetur adipiscing elit.
Precision meets performance with our Analytical Testing services. Uncover the insights that drive success. Accurate, reliable, and tailored solutions for your analytical needs. Click now to elevate your quality assurance to the next level.
At Aragen, we have a proven history of reliably developing and manufacturing high-potency APIs and compounds for our clients. This includes a diverse range such as immunosuppressants, cytostatic/protein kinase inhibitors, ultra-potent cytotoxic drug substances, drug linkers, PEG and cyclodextrin polymeric conjugations, and toxins for antibody drug conjugates (ADCs).
Our state-of-the-art facilities enable scientists and engineers in adopting data-oriented development approach to ensure flawless scale-up.
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We provide an extensive technology transfer initiative aimed at implementing a reliable scale-up model, ensuring a seamless manufacturing process from clinical to commercial stages. Our collaboration with your team mitigates commercialization risks, guarantees manufacturability, and ultimately delivers high-quality.
Lorem ipsum dolor sit amet, consectetur adipiscing elit.
Lorem ipsum dolor sit amet, consectetur adipiscing elit.
Lorem ipsum dolor sit amet, consectetur adipiscing elit.
With a dynamic and innovative mindset, coupled with extensive direct experience in diverse chemistries, we proactively tackle challenges in both early and late-stage development. This proactive approach ensures the seamless technology transfer from preclinical supply to late-stage development, facilitating a smooth transition to commercial manufacturing. Drawing insights from a wide range of projects, our team accelerates the overall development timelines for each new endeavour, supporting our clients from IND-enabling pharm-tox stage to global clinical trials.
At Aragen, we specialize in providing comprehensive and flexible drug development solutions tailored to meet the unique needs of our clients at various stages of preclinical and clinical development. Whether you require non-GMP or GMP grade key starting materials (KSMs), advanced intermediates, or active pharmaceutical ingredients (APIs), we deliver with precision and efficiency across all quantities, from kilo laboratory to plant scale.
Seamless integration across multiple functions, including Environmental Health and Safety (EHS), project management, quality control, quality assurance, regulatory affairs, and supply chain management, is at the core of our operational excellence. Our commitment is to meet and exceed customer expectations on quality, quantity, and on-time supply of drug substances.
