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Integrated Discovery, Development  &

Regulatory Services

Biopharmaceuticals

Bioneeds is dedicated to provide end-to-end Biologics Drug Development Services with its two distinct technology platforms:

  • Preclinical Platform
  • Drug Development Platform

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 OECD-GLP and AAALAC certified animal facilities.

We have the expertise to handle Novel Biologics, Biosimilars and Biobetters.

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
  • PK / PD
  • Immunogenicity
  • POC studies MOA

Biopharmaceuticals

  • Pre-clinical Toxicology (GLP / Non GLP)

RCGM; EMEA; US-FDA

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

Method Development; Validation;

Sample Analysis

  • PK/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 and Pharmacopeia)

  • Product Release Testing

Compliance to Standard Guidelines and Pharmacopeia

  • Sequence to Clinic (Pre-IND Package)

Complete Product Development (starting with sequence) with tox material supply

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