BeOne Medicines
BeOne Medicines, formerly known as BeiGene, is dedicated to creating the world's next-generation cancer treatments through relentless innovation. The company aims to deliver these transformative medicines to more people around the globe faster, more equitably, and affordably. With a mission to challenge the status quo in cancer treatment, BeOne is advancing a broad and deep pipeline, accelerating development through rigorous science, and supporting a global network of manufacturing sites to improve patient outcomes worldwide.
Industries
Nr. of Employees
Very Large (1000+)
BeOne Medicines
Cambridge, Massachusetts, United States, North America
Products
BRUKINSA
A small molecule inhibitor of Bruton’s tyrosine kinase (BTK) used for treating various B-cell malignancies.
TEVIMBRA
A humanized monoclonal antibody targeting the PD-1 receptor, approved for treating various solid tumors.
Global Patient Safety
A program ensuring the safe use of medicines throughout their lifecycle, from clinical trials to commercialization.
Manufacturing Facilities
Facilities for producing small and large molecule medicines, supporting clinical research and global commercialization.
BeiGene Foundation
A nonprofit organization providing grants to eliminate barriers to cancer care in underrepresented communities.
BRUKINSA
A small molecule inhibitor of Bruton’s tyrosine kinase (BTK) used for treating various B-cell malignancies.
TEVIMBRA
A humanized monoclonal antibody targeting the PD-1 receptor, approved for treating various solid tumors.
Global Patient Safety
A program ensuring the safe use of medicines throughout their lifecycle, from clinical trials to commercialization.
Manufacturing Facilities
Facilities for producing small and large molecule medicines, supporting clinical research and global commercialization.
BeiGene Foundation
A nonprofit organization providing grants to eliminate barriers to cancer care in underrepresented communities.
Services
Contract development and manufacturing (small molecules, OSD, biologics, conjugates, injectables)
End-to-end development and manufacturing services covering API synthesis, process development, formulation, aseptic and finished-dose manufacturing at pilot and commercial scale.
Analytical development and testing services
cGMP laboratory services for analytical method development, structure elucidation, method transfer, qualification and stability testing to support CMC and regulatory filings.
Process development, cell line services and technology transfer
Process optimization, cell line development, route selection and rapid tech transfer services including cleaning method development and scale-up implementation.
Regulatory CMC documentation and submission support
Preparation and support for CMC components of IND/CTA and other regulatory submissions, including dossier preparation and agency interaction coordination.
Global clinical operations and investigator-network support
Global clinical operations support including trial identification, investigator-initiated trial facilitation and access to investigator networks to support multi-region oncology studies.
Contract development and manufacturing (small molecules, OSD, biologics, conjugates, injectables)
End-to-end development and manufacturing services covering API synthesis, process development, formulation, aseptic and finished-dose manufacturing at pilot and commercial scale.
Analytical development and testing services
cGMP laboratory services for analytical method development, structure elucidation, method transfer, qualification and stability testing to support CMC and regulatory filings.
Process development, cell line services and technology transfer
Process optimization, cell line development, route selection and rapid tech transfer services including cleaning method development and scale-up implementation.
Regulatory CMC documentation and submission support
Preparation and support for CMC components of IND/CTA and other regulatory submissions, including dossier preparation and agency interaction coordination.
Global clinical operations and investigator-network support
Global clinical operations support including trial identification, investigator-initiated trial facilitation and access to investigator networks to support multi-region oncology studies.
Expertise Areas
- Clinical trial management and global patient enrollment
- Clinical pharmacology and ADME studies
- Large-scale biologics manufacturing and single-use bioreactors
- Small-molecule API synthesis and process chemistry
Key Technologies
- Single-use bioreactors
- Batch, fed-batch and perfusion cell culture
- Conjugation chemistry for ADCs
- Lyophilization