GMP Readiness
Expert process and analytical development teams will collaborate with your team to optimize and scale your processes for GMP production and higher throughput.
Service
Clinical Manufacturing
Phase-appropriate manufacturing with integrated testing from early stage to later phase and pivotal trials.
Accelerate clinical production
Experienced Clinical Production
Robust experience and track record in cell and gene therapy for all phases of clinical trials.
Proven Track Record
Experience includes thousands of GMP batches released for use in clinical programs.
Integrated Testing
In-house analytical method development and bioanalytical testing shortens timelines and reduces risk.
Expert Regulatory Support
Phase-appropriate regulatory support focused on expedited release and approvals.
Flexible Production
Manufacturing planning and capacity optimization supports variable schedules and filing deadlines.
Why Us?
Our integrated development, manufacturing, testing, and regulatory support services streamline production and timelines.
GMP Readiness
Expert process and analytical development teams will collaborate with your team to optimize and scale your processes for GMP production and higher throughput.
Integrated Testing
Bioanalytical testing co-located with on-site manufacturing reduces risks and expedites in-process and release testing as well as issuance of final Certificates of Testing (COT) and Certificates of Analysis (COA).
Fill & Finish
GMP production operations and fill/finish operations are on site, saving time and minimizing the risk of transporting product and freeze/thaw damage.
Regulatory Support
Successful completion of inspection and certifications from a variety of US and international regulatory agencies and ability to support Pre-IND, IND and BLA submissions.
Streamlined Execution
All manufacturing and testing services managed under a single MSA and work order, saving you time and effort in contracting. You will also be assigned a single project manager, saving you time and reducing risks related to communication issues.
Integrated Testing, Development & Manufacturing
Leverage WuXi Advanced Therapies’ proven experience to help drive commercial readiness and scale. Take advantage of co-located bioanalytical testing to reduce risks and streamline timelines. Capitalize on our regulatory experience and support services.
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Cell and Gene Therapy Expertise
Our team has experience with a wide variety of product types in all phases of clinical production.
Cell Therapies
CAR-T
CAR-NK
T-Cell
TIL/MIL
TCR
MSC
IPSC
Gene Therapies
AAV
LLV
HSV
Adeno
Testing Services
Lot release packages
In process testing
Testing for adventitious agents/toxins
Product characteristics (e.g. genome, potency, etc.)
Residuals
Identity
Viral clearance
Stability studies
Cell banking