Clinical & Commercial
Scalable, Compliant Manufacturing
to Bring Biologics to Market
The clinical and commercial phases of large molecule drug development demand highly controlled, scalable and compliant manufacturing processes.
Biologics Development
Robust cell line development is essential for consistent biologics production.
1
Cell Line and Strain Development
Expertise in developing stable, high-producing cell lines and microbial strains including E. coli, Bacillus subtilis, Pichia pastoris, Saccharomyces cerevisiae and mammalian hosts such as CHO GS-/-, HEK293 and Sp2/0.
2
Upstream Process Development
Optimization of batch, fed-batch and perfusion culture strategies to maximize yield and maintain product quality. Tailored approaches for biosimilar quality modulation ensure comparability to reference products.
3
Scale-Up and Tech Transfer
Seamless transition from lab-scale to commercial bioreactors with thorough process characterization and documentation to support regulatory filings.
Downstream Process Development
1
Purification & Recovery
Advanced chromatography (affinity, ion exchange, size exclusion) and filtration (ultrafiltration, diafiltration) techniques ensure high purity and stability of biologics.
2
Fermentation Suites
Multi-product facilities equipped with fermenters ranging from 50L to 30,000L, including stainless steel and single-use bioreactors.
3
Mammalian & Microbial Production
Dedicated suites for microbial fermentation (50L–30kL) and mammalian cell culture (200L–2000L single-use bioreactors).
4
Process Qualification & Scale-Down Models
Use of scale-down models to optimize and validate processes before full-scale manufacturing. Comprehensive process qualification and technology transfer to GMP sites.
5
Drug Product Manufacturing
Capabilities for aseptic fill-finish in vials, prefilled syringes (PFS) and lyophilized powders, supporting clinical and commercial packaging needs.
6
Product Expertise
Extensive experience with monoclonal antibodies, recombinant proteins and enzymes, addressing unique purification challenges for each class.
Quality Assurance & Regulatory Support
1
cGMP Compliance
Robust quality systems ensure batch-to-batch consistency, product safety and regulatory adherence.
2
Regulatory Documentation
Support for IND, BLA and global submissions with comprehensive CMC documentation and validation data.
3
Commitment to Excellence
Anthem’s integrated approach ensures product integrity from development through commercial supply, enabling timely market access.