Cell and Gene Outsourcing
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What To Consider When Looking To Partner With A CDMO
2/23/2021
Quite often, clients focus primarily on capacity availability, scheduling, and commercial terms. Read an industry experts views on overlooked considerations when partnering with a CDMO.
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An Audacious Gene Therapy Program Creates A New CDMO Leader
2/23/2021
The road to the formation of Andelyn Biosciences started more than 15 years ago on the third floor of a research building at Nationwide Children’s Hospital in Columbus, Ohio. At that time, GMP facilities were unheard of at children’s hospitals and gene therapy research was a rarity.
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Andelyn Bioscience Solutions
2/23/2021
Looking for scalability in clinical manufacturing? Andelyn Bioscience’s current Good Manufacturing Practices (cGMP) Clinical Manufacturing Facility operates according to FDA cGMP Guidelines and with multinational health agencies around the world.
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Pioneering Cell & Gene Therapy Solutions
2/17/2021
As a full-solution ancillary reagent and services provider, we will stand by you, providing flexible and pioneering tools to simplify your workflow. From CAR T cells to pluripotent stem cells, let us help you get your therapy to the patients that need it!
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Ocular Drug Delivery – Developing Polymeric Implants And Other Formulations For Precise Intravitreal Administration
2/17/2021
The development of polymeric formulations such as intra-ocular implants designed for the precise intravitreal delivery of drug products represents one of the most promising, yet challenging, areas of pharmaceutical focus. Review key challenges and emerging opportunities for ocular drug delivery as well as some of the latest excipients and process options available today.
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Evaluating Quality Systems With Your Manufacturing Partners
2/12/2021
The landscape surrounding regulatory guidance is constantly changing as the cell and gene therapy industry continues to evolve. Ken Bonnell, Senior Vice President of Quality and Regulatory Affairs, shares insight on what to look for and what is important when evaluating quality systems with manufacturing partners.
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Ology Bioservices Snapshot
2/8/2021
Watch this short video for an overview of the cGMP and non-GMP high-quality services offered by this U.S.-based biopharmaceutical CDMO.
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Beyond CDMO To Trusted Partner
2/8/2021
We work closely with our clients, providing CGMP and non-GMP services for the development and production of cell and gene therapies, viral vectors, oncolytic viruses and vaccines against infectious diseases and cancer.
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Technology Transfer Project Management Best Practices In The ERA Of COVID-19
1/28/2021
Since the onset of the COVID-19 pandemic the industry has shifted into high gear to develop, test and manufacture diagnostic tests, vaccines and therapies. With these developments, the speed, challenges and stakes involved in technology transfer have reached new heights. This Q&A highlights some of the challenges and how to overcome them.
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Strategic Program Management
1/22/2021
Through our Strategic Program Management approach, we plan and structure our programs to align with your objectives. All of our processes are built around identifying and mitigating risks while allowing flexibility to change and adapt our approach to deliver the best program outcome.