Search Suggestions Antibody/fusion Protein Cell/gene Therapy Gmp Production Commercial Manufacturing Plasmid Virus Cell
Antibodies/Fusion Proteins
We have an industry leading project management team to support your project with timelines. We will assign a dedicated project manager to customers, and can tailor our products and services to your specific needs, budget and timelines.
Process & Method Development
Cell line development, process development and validation
Analytical method development and qualification
QbD Quality Study and CQA Assessment
Specification setting and product testing
Commercial DS GMP production
200 L, 1,000 L SUT
150 L, 500 L, 750 L, 900 L (on construction), 3,000 L, 4,500 L (on construction), 20,000 L (on construction) SST
Fed-batch & continuous process
DP GMP production
Aseptic filling for Vials (including lyophilization) and PFS/AI
Manual and automatic visual inspection, automatic packaging
Quality Management System
Complete quality systems
Compliant with NMPA/FDA/EMA GMP requirement
CMC document management
cGMP training
Project Management and others
Project Management
Process/method tech transfer
IND/NDA/BLA filing
Dossier preparation
Process & Method Development
Cell line development, process development and validation
Analytical method development and qualification
QbD Quality Study and CQA Assessment
Specification setting and product testing
Commercial DS GMP production
200 L, 1,000 L SUT
150 L, 500 L, 750 L, 900 L (on construction), 3,000 L, 4,500 L (on construction), 20,000 L (on construction) SST
Fed-batch & continuous process
DP GMP production
Aseptic filling for Vials (including lyophilization) and PFS/AI
Manual and automatic visual inspection, automatic packaging
Quality Management System
Complete quality systems
Compliant with NMPA/FDA/EMA GMP requirement
CMC document management
cGMP training
Project Management and others
Project Management
Process/method tech transfer
IND/NDA/BLA filing
Dossier preparation
As your partner,
we commit to assist you in achieving every of your goals.
For more inquiries,please contact：bd@altruistbio.com
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