Overview

In order to gain an FDA approval, safety and efficacy of the new drug or drug product must be proven through use of supporting scientific evidences. The demonstration of proper control and validation of processes and controls undertaken must be done to ensure that the product meets the established standards of quality.

We take part on several preclinical to clinical testing to determine efficacy of medical drugs and substances.

Our dedicated scientist can serve as your partner from lead optimization to commercialization for your next advanced therapy.

Formulation Services

For those customers that require enhancing the half-life and stability of their final drugs or bioactives, we offer cutting edge formulation services using encapsulation technology that are based on biocompatible polymers, polysaccharides, and other macromolecular or lipid-based carriers.

We Offer:
  • Encapsulation of Fat-Soluble Compounds
  • cGMP- compliant Nanoparticle Purification using Tangential Flow Filtration Systems
  • Research and Development: Plain and Encapsulated Liposomes, Polymersomes, Polymer
  • Nanoparticles and other Formulations
  • Customized Surface Modification of Nanocarriers
  • Custom Formulations
  • Encapsulation of Small Molecules, Therapeutic Agents, Bio-actives and Nucleic Acids
  • Encapsulation of Vitamins and Supplements
  • Nanoparticles Production Process Control
  • Analytical and Characterization Services: Analysis and Reporting

Biopolymer Encapsulation Services

Our scientific and bioengineering teams have the knowledge and years of experience to support our clients with different encapsulation approaches during R&D, drug development and manufacturing for several applications.

We Offer:
  • Formulation development studies, including conditioned media for cosmetics or wound healing purposes
  • Transdermal and topical emulsion-based formulation development
  • Inhalation and nasal formulation development
  • Oral-dispersing film and sustained-release development
  • Customized homogenizing needs for oral tablets
  • Drug substance and excipient development
  • Micro-/ Nano-encapsulation technologies for tasting or smelling masking
  • increase bioavailability
  • Shelf-life and stability testing under accelerated conditions for pharmaceutical or skin products
  • 3D in vitro technologies for cosmetic products testing
  • 3D in vitro lung efficacy studies for compounds/ ingredients testing
  • 3D organoids using miniaturized bioreactors for diseases modelling
  • Technology transfer and process validation
  • Compilation of regulatory dossier and documentation to a regulatory body of interest

Other Customized Services

Our manufacturing facilities are world-class built in accordance to PIC/s and HSA CTGTP guidelines. we develop the full process validations, product characterization, and production for all clinical trial phases.

Fill and Finish Services

Our fill and finish services cater to preparations in which the end product is in liquid, cell, or vial form. This production of clinical trial ready product can be done in a ready-to-use vial filling line with integrated freeze drier integrated in an isolator. The same cGMP-compliant process can be applied to client’s dosage, formulation and filling requirements defined in the dossier submission package.