Gene design to manufacturing

  •   Biologics   •   Biosimilars   •  mAbs

  •   Semi-synthetics   •   Proteins

  •  Bacterial     •  Yeast  
  •  Mammalian

Biologics development

Cell line/Strain development

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  • Bacterial- Escherichia coli, Bacillus subtilis
  • Yeast- Pichia pastoris, Saccharomyces cerevisiae
  • Mammalian- CHO GS-/-, HEK293, Sp2/0
  • Host selection, gene design, expression construct optimization, stable clone/strain development, and stability assessment

Upstream Process Development

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  • Batch, fed-batch, and perfusion strategies to identify high-yielding process
  • Process strategies for biosimilar product quality modulation
  • Scale-up, characterization, and tech transfer to manufacturing sites

Downstream Process Development

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  • Process development with various chromatography systems and filtration systems
  • Scale down models, process qualification, and tech transfer
  • Experience with antibodies, recombinant proteins, and enzymes

Analytical Development and Characterization

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  • Complete analytical and bioanalytical characterization of various biologics
  • Method qualification, validation, and transfer in compliance with the cGMP regulations
  • QC equipped to cater in-process, bulk intermediate, and drug substance testing
  • Analytical and characterization services for mAbs, proteins, peptides, and small molecules
  • Analytical method development, qualification and validation/technologies transfer in compliance with the cGMP regulations
  • QC equipped to cater in-process, bulk intermediate, and drug substance testing requirements, stability testing and establishment of batch release studies

Protein sciences and Molecular Biology

Transient protein expression & purification

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  • Transient/episomal expression of protein in various bacterial, yeast, and mammalian hosts
  • R&D to large scale expression and purification (milligram to grams) with client specified purity
  • Customized protein characterization

Optimal host selection for protein expression

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  • Identification of ideal host for expression of protein
  • Determination of ideal expression strategy – episomal or stable integration
  • Selection of host through multifaceted, matrix approach

Strain and expression enhancement

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  • Microbial strain improvement through classical and targeted mutagenesis
  • Expression enhancement through evaluation of multiple genetic elements – promoter, signal sequences, and tags
  • “Scar-free” knock-out and knock-in of multiple genes

Molecular biology

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  • Expression vector construction in standard expression systems
  • De novo expression vector design with in-house genetic elements
  • Random and site – directed mutagenesis
  • Plasmid preparation: miniprep to gigapreps
  • Gene expression and copy number analysis

Antibody generation and preclinical evaluation

Custom hybridoma & polyclonal Ab generation

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  • Mouse monoclonal hybridoma generation
  • Counter screening, binding affinity assays
  • Rabbit and mice polyclonal Ab generation

Immunogen/ antigen generation

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  • Generation of immunogen /antigen in expression host of choice
  • Protein expression and purification at >95% purity and endotoxin at 1EU/mg
  • Chemical synthesis of simplex and complex peptide and chemical antigens

Hybridoma scale-up and antibody production

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  • In vitro scale-up of hybridoma for mg/gram expression (SF or bioreactor)
  • Purification either through protein G or neutral pH at >95% and endotoxin at 1EU/mg or lower
  • Research or master cell banking

Pre-clinical services for mAbs

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  • In vivo efficacy studies and pharmacokinetics
  • Exploratory and regulatory toxicology
  • Immunogenicity assessment

CMO services

Mammalian GMP

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  • Pilot: 200L with downstream support (AKTA process, AKTA pilot, centrifuge, TFFs and others)
  • Manufacturing (Q2 2022): 2 x 2000L with downstream suites and all supporting functions

Microbial GMP

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  • Pilot: 2 x 75L with downstream support
  • Manufacturing: Total capacity of 100,000L of fermentation volume (2 x 42,000 L)
  • Major downstream: Continuous Cell separator, Cell disruptor, centrifugation, Micro/Ultra/Dia-filtration, multiple hollow fiber module, Several chromatography systems, lyophilizer and spray dryer

Analytical development, characterization, and QC services

Attributes Method
Primary Sequence
Primary sequence Composition Peptide mass finger printing (LC-ESI-MS), Intact Mass (LC-ESI-MS)
Sequence confirmation Peptide Mapping, N- and C-Terminal Sequencing
Disulfide bonding confirmation LC-MS/MS
Glycosylation analysis LC-MS/MS, 2-AB/RFMS based U/HPLC
Charge analysis CEX, IEX-HPLC, cIEF
Degradation analysis SEC, RP, SDS-PAGE, cIEF, IEX
Secondary and Tertiary structure
Secondary and Tertiary structure Disulfide mapping, CD Spectroscopy (Near & Far UV), Intrinsic Fluorescence, DSC
Product-related impurity analysis
Product-related impurity analysis Size variants (Aggregates, and degradants) SEC-HPLC, SEC-MALLS, SDS-PAGE
Charge variants IEX-HPLC, CEX, cIEF
Glycan variants UPLC/HPLC based Glycan analysis
Process-related impurity Analysis
Process-related impurity Analysis HCP (Host-Cell Protein), HCD (Host-Cell DNA) and PAL (Protein-A leachates) & Endotoxin analysis
Functional activity
Functional activity In-vitro/vivo functional assays, cell based receptor binding assay
Quantification Bradford, Lowry, BCA, ELISA, Octet (2020)


Upstream – Mammalian

  • •  D: 1L - 5L, Wave Bioreactors
  • •  Pilot GMP: 7L - 200L SS Bioreactors
  • •  cGMP: Upto 2kL Single Use facility
        (2022 Q2)

Upstream – Microbial

  • •  D: 2L - 25L
  • •  cGMP: 75L – 42 kL SS Fermenters

Downstream – Mammalian

  • •  AKTA Pure
  • •  AKTA Pilot
  • •  AKTA Process
  • •  TFF

GMP Manufacturing

  • •  Fermentation volume: 100,000 L
  • •  Fermenter scale: 70 L - 42,000 L
  • •  Output: Kilogram to tons

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