Ensure speed to clinic and to market with our bespoke and tailored development and manufacturing programs
The growing promise of biopharmaceuticals opens significant commercial opportunities for drug developers. At the same time, it also increases the pressure to rapidly bring candidates to the clinic and therapies to market.
To accelerate your path to your next milestone, we offer programs for the entire lifecycle of any molecule type, from preclinical to commercial stages, from drug substance to drug product.
Depending on the needs of your molecule and your priorities in terms of timelines, yield optimization and risk, we can leverage our global network and capabilities to offer bespoke and tailored programs:
DNA to Clinic Programs
Clinic to Market Programs
- Tailorable IND to BLA program
- Tailorable commercial program
- Ibex® Dedicate
The variety of our offerings provides the flexibility of a complete program or the option to drop in at a later stage depending where you are in your journey.
Access our end-to-end portfolio of services to quickly and efficiently develop and manufacture any type of mammalian derived biopharmaceuticals
As you move your molecule from the research phase into clinical and commercial manufacturing, key challenges to be addressed include the need to maintain high productivity, product quality and reproducibility. A successful outcome will often require significant technical expertise and advanced development and manufacturing technologies.
In our extensive services portfolio, we use advanced technologies and decades of know-how to quickly and efficiently develop and manufacture biotherapeutics such as monoclonal antibodies, bispecific antibodies, Fabs, fusion proteins, scaffolds and other recombinant proteins.
Seven sites across the world are continuously expanding to support your regional clinical and commercial needs
We develop and produce mammalian-derived biopharmaceuticals in highly advanced cGMP multi-product facilities, in a global network across three continents: America, Europe and Asia.
We work with clients of all sizes, from small biotech to multi-national pharmaceutical companies, tailoring our services to meet your specific needs. We are committed to your success to help you meet your product and company milestones.
Shaped Around You
During drug development, it is critical to balance risk with time and costs. We understand the complexity of building such optimal paths. By offering flexibility on your journey to IND, we can shape our process around your molecule’s profile, critical milestones and company’s needs.
Our locations
Locations where these services are provided
Regulatory expertise
Pathway to success in Regulatory filings
Extensive Regulatory Expertise
We offer our in-depth expertise in the interpretation of legal requirements and guidance in innovative and emerging markets. Our regulatory affairs CMC experts are co-located alongside subject matter experts at our manufacturing sites around the globe. Our team has extensive experience in CMC dossier writing as well as preparing responses to questions from health authorities across the world.
Dedicated Regulatory Affairs Contact
We ensure that each project has one dedicated regulatory affairs point of contact who, in partnership with you, will develop and finalize a regulatory CMC strategy. The strategy will ensure you have the required data to support global applications.
Keep Pace with Regulatory Thinking
Our Regulatory Affairs Services prioritize transparent communication. We ensure that you are continuously informed from kick-off and during subsequent interactions, facilitating any CMC development strategy or detailed discussions.
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