Large Molecule R&D

GVK BIO offers a complete range of Large Molecule R&D services from routine projects to highly customised and complex study designs. Each of these services can be applied to the research, optimisation and development phase of a project. Our services are highly collaborative, well-documented and timely which gives you control over the entire process. Our integrated Biologics service offerings include: antibody discovery, antibody humanisation, recombinant protein production and purification, cell-based and in vivo models of disease assays, and stable cell line development. Our team has been chosen for their scientific experience, expertise and diversity. We have pride in our ability to understand each clients’ unique needs both from a scientific as well as business perspective. Our customer dedicated research teams ensure the project gets the attention and focus it deserves to lead to a successful outcome.

GVK BIO offers Biologics services through its subsidiary Aragen Biosciences located in the Bay Area, San Francisco. Aragen Bioscience is a leading contract research organisation, focused on accelerating product development with high quality science, professionalism and innovation. To know more visit www.aragenbio.com

Comprehensive Solutions for the Biopharmaceutical Industry from Concept to IND

  • Immunogen/antigen design
    • Whole cells, liposomes, bead based, recombinant proteins
  • Rodent immunisation and hybridoma generation
  • Complex screens (e.g. FACS based)
  • Diverse applications
    • Therapeutics
    • Diagnostics
    • Analytical tools (e.g. FACS, ELISA)
    • Various immunisation strategies
  • Antibody humanisation via XOMA’s Human EngineeringTM platform
  • Molecular biology
  • Transient transfection
    • CHO, HEK-293, CAP-T, BHK, NRC pTT5 system, others
  • Stable CHO, Hybridoma (or other) cells
  • 175L (7x25L WAVE) capacity
  • Nine (9) bench-scale stirred tank bioreactors
  • Protein purification and analytics
    • Protein A/G, IEX, HIC, etc.
    • Scouting studies to identify resin, buffers and elution conditions
    • Low endotoxin, low host cell proteins and DNA, high purity
    • Analytical testing (e.g. SEC-HPLC, SDS-PAGE, N-Glycan, others)
    • Thermal stability and formulation studies
  • Protein binding characteristics; ForteBIO Octet
    • Target affinity and/or cross reactivity
    • Fc receptor binding (e.g. CD16, FcRN, C1q, etc.)
    • Custom attributes specific to application
  • Other protein activity analytics (e.g. enzymatic function)
  • Cell based bioactivity and other analytics
    • ADCC, CDC, proliferation, apoptosis, B-cell depletion
    • Signaling, migration, cell morphology, chemotaxis
    • Cytokine response, clonogenic survival, immunophenotyping
    • ROS and NO assays, mitochondrial function
    • Primary cells, cell lines, ex-vivo tissue culture
  • Tumor models
    • MCF7
    • MDA-MB-231
    • Daudi
    • A549
    • HCT116
    • HT1080
    • Metastatic
    • Subrenal Capsule
    • Orthotopic
    • Synergic
    • Others
  • Inflammation
    • CIA, AIA
    • Atherosclerosis
    • Asthma
    • IBD
  • Respiratory disease
    • Asthma
    • RSV
  • Arterial thrombosis
  • Fibrotic disease
    • Liver, Lung
  • Custom models
    • Team of local consultants
    • Adapted from the literature, academia
    • Novel model set up
  • Wound healing
    • Dermal wound
    • Cartilage Repair
  • Immunological disease
    • Systemic Lupus Erythematosus (SLE)
    • Multiple Sclerosis (EAE)
    • Anaphylaxis
  • Respiratory disease
    • RSV, C. difficile, mCMV
  • Royalty free CHO DG44 platform with in-house vectors and successful regulatory experience
  • Fut8 Deficient CHO-DG44 Cell Line for afucosylated products
  • Licence to ProteoNic genetic elements for increased expression
  • Licence to CEVEC Pharmaceuticals CAP system
  • Experience with diverse expression platforms (GS, UCOE, ACE)
  • Clone pix based picking methods
  • Diverse product experience (clotting factors, hormones, cytokines, and novel and biosimilar antibodies)
  • Custom and routine analytical assay development
    • IEF, ELISA, HPLC, N-Glycan, etc.
  • Upstream: Cell Culture
    • Nine (9) bench-scale stirred tank reactors
    • Basal medium screening and spent medium analysis
    • Fed-batch assessment with concentrated nutrient feeds
    • Set point (e.g. temperature shift, pH) evaluation
    • Custom medium development
  • Downstream: Purification
    • Harvest and clarification method assessment
    • Resin scouting and associated mass balance analysis
    • Product quality analytics (e.g. SEC-HPLC, N-Glycan, bioactivity, etc.)
    • Thermal stability and formulation studies
    • Host cell contaminant analytics (e.g. HCP and HC-DNA)

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