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.

Related Resources

Webinar: Balancing Risk, Speed, and Cost in Biopharmaceutical Process Development & Manufacturing

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.