Biopharmaceutical Services

Bioneeds is dedicated to provide end-to-end biologics drug development services with its two distinct technology platforms:

  • Dose limiting toxicology studies
  • Dose escalation toxicology studies

Capabilities include development of recombinant proteins such as non-glycosylated proteins; glycoproteins and monoclonal antibodies derived from either bacterial or mammalian host expression systems.

Our preclinical platform is supported by the OECD GLP & AAALAC certified animal facilities.

We have the expertise to handle novel biologics, biosimilars and bio betters.

biopharmaceutical Services

CQA Driven Process & Product Development

  • Cell line development
  • Cell banking & characterization
  • Upstream process development
  • Downstream process development
  • Formulation & stability

Well Characterized Products

  • Structure
  • Function (MOA)
  • Safety
  • Toxicology
  • Immunogenicity

Preclinical Studies

  • Animal toxicity
  • Pharmacokinetics (PK) / Pharmacodynamics (PD)
  • Immunogenicity
  • POC studies MOA

Preclinical Platform

  • Preclinical toxicology (GLP/Non GLP)

RCG, MEME, AUS-FDA

  • Bioassays (in vitro/in vivo): (GLP/Non GLP)

Method Development; Validation; Sample Analysis

  • Pharmacokinetics (PK)/Toxicokinetic (TK) analysis (GLP/Non GLP)

Animal Studies; Sample Analysis

  • Immunogenicity Testing (GLP/Non GLP)

Antibody Generation; Screening Assays; Confirmatory Assays; Neutralizing Antibody Assays

  • Impurity Analysis (GLP/Non GLP)

HCP; HCD; Others

  • Antibody Development (monoclonal/polyclonal)

Immunization; Purification; Characterization; Reactivity

Drug Development Platform

  • Cell line development

Codon optimization; clone stability; bioreactor suitability; titre; product quality

  • Process Development

Cell culture & purification; critical process parameters; COGS

  • Product Characterization

Analytical; bio/analytical; potency (compliance to standard guidelines & pharmacopeia)

  • Product Release Testing

Compliance to standard guidelines & pharmacopeia

  • Sequence to Clinic (Pre-IND Package)

Complete product development (starting with sequence) with tox material supply