Contact
Parc d'activités Bièvre Dauphine - 885, rue Alphonse Gourju
38140 Apprieu
France
Directeur commercial et marketing
About us
Custom Antibody and Immunoassay Development / Production
Expert in immunotechnologies since 1980, BIOTEM is a hybrid Contract Research Organization (CRO) and Contract Manufacturing Organization (CMO) which provides high added value services for the development / production of custom monoclonal antibodies and immunoassays (ELISA & LFIA). Complying with ISO 9001:2015 / ISO 13485:2016 Quality Standards, the company has been the privileged partner of almost 500 prestigious industrial and academic laboratories for their projects in fundamental research, development of improved diagnostics or promising therapeutic tools.
Business offer
> ANTIBODY DIVISION
- Synthetic Libraries - Phage Display: Humanized VHH and Human scFv
- Immune Libraries - Phage Display (mice, rats, llamas, rabbits, etc.)
- Hybridoma Generation and Screening (mice and rats)
- Antibody Engineering: Sequencing, In silico Humanization, Sequence Optimization, Affinity Maturation, etc.
- Optimized antibodies for IHC (FFPE) / Companion Diagnostics
- Polyclonal Antibodies and Antibodies for PK/PD analysis
- Antibody Production: Hybridomas and Recombinant antibodies (IgG, scFv, VHH, Bispecific Ab, etc.)
> IMMUNOASSAY DIVISION
- ELISA Development and Production
- Lateral Flow Rapid Test Development and Production
Activities
- Service
- Hit discovery
- Screening & Identification
- Therapeutic libraries
- In silico
- Bioinformatics prediction & analysis
- Immunotherapy lead generation
- Biophysical profile
- Binding & Affinity
- Potency & Specificity
- Epitope mapping
- Manufacturability
- Production quality
- Immunotherapy lead optimization
- Engineering
- Linkers
- Protein scaffolds
- Fragments
- Multi-, bispecific
- Fc-fusion proteins
- Antibody humanization
- Affinity maturation
- CMC
- Master Cell Bank
- Production
- Cell Line development
- Clone selection
- Characterization
- Storage
- Analytical development
- Cell Culture
- Media composition
- Bioreactor conditions
- Bioproduction
- Batches production type
- Mammalian
- Bacterial
- Pilot Batches
- Tests
- Optimization
- Scale-Up process
- Process optimization & validation
- Volume
- Preclinical / Tox
- Low volume (< 200 L)
- High volume (200 – 2000 L)
- Very high volume (> 2000 L)
- USP (Scale-Up)
- Cell expansion
- Inoculation
- Low volume containers to Bioreactors
- DSP (Recovery)
- Harvest
- Filtration
- Purification
- Fill & Finish
- Aseptic filling
- Lyophilization
- Batch release
- Storage matter
- Logistic
- Cell cryopreservation
- Controlled-rated freezer
- thaw
- Quality assurance, quality control & analytical process
- Stability Assessment
- Physical & chemical profile
- pH
- Freeze/thaw
- Heat/degradation
- Aggregation
- Cell line analytical development
- Contaminants detection
- Biosafety & Bioanalysis
- Impurities detection
- Batch release test
- Chemical, physical, biological test
- Quality control test support
- Post-production test
- Real-time stability test
