Outsource your Fast-Track Biologic Drug Development
Confidently shorten your timelines to commercialization with an agile, full-service biologics CDMO partner for greater speed, foresight, and regulatory support.
Once you receive a fast-track, orphan drug or breakthrough therapy designation, timelines compress. You need to move aggressively toward milestones while remaining closely aligned with regulatory requirements and avoiding risks that might delay or derail your project.
When time is of the essence, you need a CDMO partner with the experience and ability to:
- Deliver against shrinking timelines without sacrificing quality and safety
- Anticipate and plan for commercial-scale manufacturing from the beginning
- Understand, interpret and adapt to regulatory expectations
- Respond to unpredictability in market demand
- Safeguard the supply chain of raw materials
Fast-Track Drug Development Capabilities From DNA To Commercialization
Our Fast-Track development service accelerates progress toward clinical and commercial milestones. From Day 1, we maintain a view of the ultimate measure of success – helping your drug get to patients in need, faster and with less risk.
We combine best-in-class templates, a multi-disciplinary team informed by three decades of technical experience, a full understanding of evolving regulatory requirements, and project managers fully vested in your success. Our single-use technologies offer unmatched flexibility for both clinical and commercial scale production, and for those times when demand changes unexpectedly. We are nimble, agile, and will advance your project quickly while mitigating risk – and that adds up to greater confidence for you.
Our Fast-Track capabilities span every step from DNA to commercial production.
From DNA to first GMP batch
- Cell line development, or transfer of your existing cell line
- Upstream and downstream process development
- Analytical development
- Final formulation development
- Expert support for meetings with regulatory agencies
- Drug substance production at clinical scale
- Final drug product filling
From process characterization to commercial production
- Process characterization
- Process and analytical validation
- PPQs for commercial
- Expert support for meetings with regulatory agencies
- Drug substance production at commercial scale
- Final drug product filling
Here’s how you’ll benefit from our Fast-Track Drug Development Service
Single-Source CDMO for all Development and Manufacturing Operations
Includes cell line development, process and analytical development, clinical and commercial-scale production of drug substance and drug product, including raw material supply
Flexibility as Regulatory Requirements Evolve
The ability to adjust process development and validation strategies based on feedback and requirements from regulatory authorities.
Support for Meetings with Regulatory Agencies
- Dedicated regulatory expert throughout the duration of the project
- Assistance in discussions with sponsor and regulatory health authorities
- Assistance in sponsor IND/BLA submission
- Redaction of CMC package clinical and commercial
- Post IND/BLA submission support
Accelerated Timelines
The potential to advance from DNA to IND in 12 months and from process characterization to commercial production in 24 months.
Open and Transparent Communication
Your project manager serves as your single point of contact from start to finish, ensures close collaboration, and coordinates direct interface with your technical, operations and quality teams, as well as support for meetings with regulatory agencies.
Confidence from an Integrated Value Chain
Multiple, full single-use manufacturing suites, each equipped with similar equipment at same scales from 200L to 2,000L. This allows for de-risked, streamlined technology transfer from clinical to commercial scales across sites, without the need for process fitting and with simplified process validation.
Security of Commercial Supply
We produce up to 80% of the raw materials used in your process. With control over the supply chain, we mitigate risks associated with disruptions and unpredictable drug production forecasts. Harmonization of equipment across sites, along with use of templated processes, allows us to stockpile critical materials for production.
Get in touch with our multi-disciplinary team of experts to discuss what’s your best path forward on fast-track drug development.
Full-service biologics CDMO
BioReliance® End-to-End Solutions is a full-service biologics CDMO offering deep expertise and flexible, custom solutions at all stages of development and manufacturing for your monoclonal antibody, bispecific antibody, ADC or fusion protein. Our services span from mammalian cell line and process development to media and feed screening, master cell banking, clinical scale-up, and GMP clinical and commercial drug substance manufacturing. Plus, our analytical methods development, validation and testing are all done in house.
With more than 30 years’ experience in process development and 25 years in manufacturing, we’ve helped to bring more than 270 biologics to market and we have released 85+ GMP drug substance batches since 2012 over a range of molecules and scales.
As a fast-track CDMO partner with world-class expertise in regulatory compliance, we’ll balance risk to optimize your speed to market and support all aspects of your regulatory compliance. And as trusted experts in single-use technologies with a global network of GMP-certified facilities, we can cater to your specific manufacturing requirements and facilitate direct and efficient tech-transfer.
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