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What we do

Extensive in-house capabilities for drug development

In-house expertise, state-of-the-art infrastructure, facilities, labs, processes and knowledge to support the drug development cycle. All under one roof.  

CMC

Our world-class CMC (Chemistry, Manufacturing, and Controls) capabilities deliver unprecedented quality and consistency, to ensure foolproof manufacturing of the final pharmaceutical product. Our company is singly focused on developing new and better drugs, and through collaborative alliances with relevant third parties, transforming ideas into approved products ready for market. Our team brings decades of experience in protein and peptide-based drug development for clinical trials and regulatory approval processes.

CMC capabilities include:

  • Variants design and screening
  • Small scale peptide synthesis, purification and characterization
  • Bacterial expression lab
  • Mammalian cell line development
  • Upstream process development in various fermenter and bioreactor sizes
  • Purification development
  • QbD and DoE methodologies
  • Pilot scale production and purification for preclinical studies
  • Development of drug formulation, liquid or lyo
  • HPLC based, biological methods and characteristics-based analytical development and qualification
  • GMP certified QC release in house for clinical phases 1-2
  • Managing production in CMOs for clinical phases 1-3
  • Product characterization
  • Stability studies

Preclinical Department

The preclinical team leads the studies necessary to bring an idea to clinical trials through the preclinical stages required to prove the concept and to evaluate drug safety and toxicity. The drugs are evaluated using the relevant animals and in vitro models to assess potency, efficacy binding affinities and longevity. The team has excellent and proven capabilities in conducting the studies in-house, in our state-of art laboratory, and with the lead CROs. The team works according to regulatory preclinical requirements and prepares the preclinical package for submission.

The Bioanalytical GLP Unit

The GLP Bioanalytical (BioA) unit develops and validates bioanalytical (PK) and immunogenicity methods to support any phase of the drug development from toxicology studies through clinical trials. The BioA unit is certified to manage the different aspects of sample analysis, including sample receipt, analysis and archiving, applying GLP principles and regulatory requirements.

Clinical Services and Capabilities

Managing (including through collaborative alliances with relevant third parties) all aspects of clinical development under global regulations, from clinical trial setup to KOL recruiting and site identification and qualification. We have extensive experience with managing laboratories in different regions, and the know-how and experience to manage CRO and vendors on a global scale.

On the supply and documentation side, we offer IP strategic forecasting, supply optimization, as well as managing eTMF to be Inspection Ready (IR) for different types of clinical trials and in compliance with GDP and GCP.

QA & Regulatory

Our robust Quality Management System is available to support a wide range of regulations, including through collaborative alliances with relevant third parties. It includes electronic document management system of SOPs, Forms, WI, all aligned for continuous improvement of safety, quality, and availability of our products. We have broad experience with service providers’ qualifications and audits, employee training, supporting CSV and laboratory equipment validation projects. We execute regular internal GMP, GLP and GCP audit programs.