Skip to main content
Advanced biologics laboratory showcasing formulation and drug delivery development capabilities

Our Expertise & Capabilities

Zyconix Biologics

Our Expertise & Capabilities

Design and optimization of novel formulations for Antibody -DrugConjugates(ADCs), biosimilars , monoclonal antibodies(mAbs), fusion proteins, glycoproteins, recombinant hormones, peptibodies, peptides, and cell&genetherapy(CGT) with a focus on stability, manufacturability, and patient convenience.

Biologics Formulation

Formulation Expertise

Antibody–Drug Conjugates (ADCs)

We develop formulation strategies for complex ADC molecules with a focus on maintaining the stability and integrity of the antibody, linker, and payload components. Our approach addresses aggregation, degradation, solubility, and product quality challenges associated with these highly sophisticated therapeutics.

Biosimilars

We support the development of robust formulations for biosimilar products with a focus on physicochemical stability, product quality, and similarity to the reference biologic. Our formulation strategies are designed to support development from early characterization through scale-up and manufacturing.

Monoclonal Antibodies (mAbs)

We develop stable and optimized formulations for monoclonal antibodies across a range of concentrations and delivery requirements. Our work addresses aggregation, viscosity, particle formation, chemical degradation, and long-term stability to support patient-centric biologic products.

Fusion Proteins

We design formulation approaches for complex fusion proteins while addressing challenges related to conformational stability, aggregation, proteolytic degradation, and interfacial stress. Our goal is to develop robust formulations suitable for both development and scalable manufacturing.

Glycoproteins

Our formulation expertise supports glycoprotein therapeutics where structural integrity and product quality are critical to biological activity. We investigate formulation and process conditions to minimize degradation, aggregation, and other stability-related changes during storage and handling.

Recombinant Hormones

We develop formulation strategies for recombinant hormones with emphasis on maintaining molecular integrity, biological activity, and stability throughout the product lifecycle. Formulation optimization can address sensitivity to temperature, interfaces, oxidation, aggregation, and other degradation pathways.

Peptibodies

We address the unique formulation challenges of peptibodies, which combine peptide functionality with an antibody-based architecture. Our development strategies focus on stability, aggregation control, viscosity, molecular integrity, and delivery requirements for these multifunctional biologics.

Peptides

We develop innovative formulations for therapeutic peptides with a focus on improving chemical and physical stability while maintaining biological activity. Our approaches can address challenges such as oxidation, deamidation, aggregation, adsorption, solubility, and delivery optimization.

Cell & Gene Therapy (CGT)

We explore formulation and delivery strategies for emerging cell and gene therapy products, with particular attention to product stability, biological activity, storage, and administration requirements. Our multidisciplinary approach supports the development of innovative solutions for complex next-generation therapeutic modalities.

Drug Device Combination Product

The successful development of a biologic therapy increasingly depends not only on the molecule, but also on how the medicine is delivered to the patient.

Zyconix Biologics brings together formulation science and drug-delivery expertise to support the development of drug-device combination products designed for reliable administration, improved patient convenience, and differentiated therapeutic delivery.

We provide science- and regulatory-based support for drug-device combination product development, from device selection through submission readiness.

Advanced drug delivery devices including an injection pen, prefilled syringe and wearable injector

Development & Submission Support

  • Characterization of innovator pack analysis.
  • Selection of Device and Primary Component.
  • Comparative Analysis against reference product.
  • Design and Development Plan
  • User Needs
  • Design Inputs
  • Design Outputs
  • Design Verification & Design Validation plan
  • Test Method Validation
  • Risk Management Plan and Report
  • Statistical Evaluation
  • Design Failure Mode Error Analysis (DFMEA)
  • Process Failure Mode Error Analysis (PFMEA)
  • Use Related Risk Analysis (URRA)
  • Product Hazard Analysis (HA)
  • Risk Analysis Matrix
  • Trace Matrix
  • Design Transfer
Emerging Technologies

Advanced Drug Delivery Technologies

Exploration and development of innovative delivery approaches that extend therapeutic reach, improve patient compliance, and reduce dosing frequency.

  • Long-Acting Injectables
  • Sustained-Release Systems
  • Topical Biologics
  • Nanoparticle-Based Delivery
Supporting Science

Analytical Characterisation

Comprehensive analytical support throughout development programmes — characterising protein structure, aggregation, stability, and product quality attributes.

Work With Us

Ready to Advance Your Biologics Programme?

We welcome collaboration with pharmaceutical companies, biotechnology organisations, academic institutions, and medical device innovators.