Enhanced solution delivers balance of speed and quality to accelerate and expedite DNA to Investigational New Drug in as little as 13 months
New and emerging biopharma companies working on early development can now leverage a better lab to clinic drug development solution designed to accelerate the journey from DNA to drug product. The enhanced Quick to Clinic solution from Thermo Fisher Scientific may help biopharma companies reach Phase I/First-In-Human trials and file for Investigational New Drug (IND) review in as little as 13 months from transfection. The new solution will be showcased this week at BIO Digital 2021.
"Emerging biopharma companies now make up a majority of the biologics development pipeline. Meeting critical milestones is paramount to the continued support of these programs, making speed to clinic more important than ever," said Paul Jorjorian, vice president and general manager, biologics, at Thermo Fisher Scientific. "With our Quick to Clinic solution, we provide biopharma companies with the supply assurance and foundational platform they need to see their therapy through to the clinic that mitigates risk, accelerates timelines and navigates the complex and changing regulatory environment. Ultimately, this will help to expedite the development of important medicines for patients."
Quick to Clinic leverages Gibco Freedom ExpiCHO – a royalty-free, high-yield expression system, that can scale seamlessly from an R&D environment – and includes critical activities such as cell line development, process fit, analytical development and qualification, yielding a robust process platform for biopharma companies developing mammalian recombinant proteins. This allows companies to scale quickly from discovery phase, leveraging toxicology and GMP material and documentation provided by the Quick to Clinic program to file for IND in an expedited manner and get to Phase I clinical trials quicker.
Jorjorian continues, "Quick to Clinic leverages Thermo Fisher's deep scientific and technical expertise, spanning decades of experience in end-to-end molecule development with more than 240 recombinant proteins and monoclonal antibody products. In addition, it features state-of-the-art technology including high throughput automation tools for cell line and process development, liquid chromatography-mass spectrometry-based multi-attribute methodology for critical quality attributes analysis, and design of experiment tools for high throughput screening."
Quick to Clinic leverages Thermo Fisher's global network of facilities and scientific experts, combined with its proven track record and more than 30 years of development and manufacturing experience, to help biopharma companies target an accelerated pathway to IND without taking on significant risks that would disrupt their goals while creating a strong foundation for future scale-up success.
BIO Digital 2021 and Fierce Pharma Webinar This week at BIO Digital 2021, the company will host a panel discussion on June 17 at 4 p.m. ET, "Approaches to leveraging lifecycle and eco-system solutions to get your molecule across the IND milestone." Learn more about the panel here.
Later this month, the company will host a live Fierce Pharma webinar, "Getting from R&D to IND: Pitfalls to avoid and how to succeed," on June 28 at 1 p.m. ET. Register for the webinar here.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
For more information, please visit www.thermofisher.com.
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