Cutting-Edge Biopharmaceutical Technologies and Services
Our comprehensive technology suite offers a wide range of analytical services, method development, and advanced drug delivery solutions. From FTIR to LC/MS, nanoparticle manufacturing, and controlled release technologies, we ensure precise and efficient formulation development.
Our capabilities extend to stability studies, GMP manufacturing, and innovative nanotechnology-based delivery systems, supporting every stage of biopharmaceutical development from early studies to clinical phases.
Analytical Services: Comprehensive Testing Solutions
Spectroscopy & Chromatography:
- FTIR, VCD, Raman, CD: Molecular analysis and structure identification.
- HPLC/UPLC, LC/MS: Compound separation, identification, and quantification.
- Gas Chromatography/FID: Volatile compound analysis.
Particle & Dissolution Testing:
- Laser Diffraction: Particle size measurement.
- USP Apparatus: Drug release profile testing.
Detection & Characterization:
- UV/VIS, ELSD, CAD Detectors: Compound detection and concentration analysis.
- Karl Fischer: Moisture analysis.
Stability & Environmental Control:
- Photostability Chamber, ICH Stability Chambers: Stability studies under specific conditions.
- Controlled Ovens: Environmental testing.
Nanoparticle Systems:
- Microfluidics, T-mixers, IJM: Nanoparticle formulation systems.
- Characterization Systems: Nanoparticle size and distribution analysis.
Electrophoresis & Scattering:
- Gel Electrophoresis: Molecular separation.
- DLS, ELS: Particle size and charge analysis.
Thermal & Rheological Analysis:
- DSC, TGA, TMA: Material stability and behavior under stress.
- Rheological Measurements: Flow property characterization of fluids.
Method Development and Validation
Our method development and validation services play a critical role in achieving the reliability, precision, and reproducibility required for analytical methods in biopharmaceuticals. We focus on the following key areas:
Impurity Isolation and Structure Elucidation:
- Identifying and isolating impurities from drug formulations to maintain product purity and safety.
- Determining the molecular structure of impurities to assess their impact on drug efficacy.
Method Validation and Verification:
- Developing and validating analytical methods to deliver accurate and reproducible results.
- Verifying existing methods to confirm compliance with regulatory and quality standards.
Reference Standard Certification:
- Certifying reference materials used as standards for accurate measurement and comparison during testing.
Studies in Support of Formulation Development:
- Conducting studies to optimize drug formulations and achieve desired specifications.
Chiral Separations:
- Specialized separation techniques to differentiate between chiral molecules, which is essential for certain drugs with enantiomers that may have different biological effects.
Charged Aerosol Detector (CAD) Method Development:
- Developing methods utilizing CAD for detecting compounds without chromophores, making it ideal for diverse pharmaceutical applications.
Stability Studies
Our stability studies are designed to assess the shelf life and long-term quality of biopharmaceutical products under controlled environmental conditions. These studies help ensure that products remain safe, effective, and compliant throughout their intended storage period. The key areas we cover include:
Stability Studies: GMP and non-GMP:
- Conducting both Good Manufacturing Practice (GMP) and non-GMP stability studies to ensure compliance with regulatory standards or to support early-stage research.
Stability Chambers Set to ICH Conditions:
- Utilizing stability chambers that follow International Council for Harmonisation (ICH) guidelines, with set conditions of temperature and humidity (e.g., 25°C/60%RH, 30°C/65%RH, 40°C/75%RH) to simulate real-world storage environments.
Color-Coding for Accuracy:
- Using a color-coding system to ensure precise identification and tracking of samples during stability testing.
ICH Guideline Test Intervals:
- Following ICH guidelines for testing intervals, ensuring consistent and accurate monitoring of product stability over time.
Stability Study Quality Attributes:
- Assessing various quality attributes during the stability study, including appearance, potency, purity, and physical characteristics, to ensure the product maintains its intended quality.
Stability Study Analysis & Reporting:
- Providing detailed analysis and reporting of stability study results, offering insights into product performance under different environmental conditions and supporting regulatory submissions.
These services ensure that biopharmaceutical products remain stable and effective throughout their lifecycle, meeting the required quality and regulatory standards.
Formulation Development
Our formulation development services provide comprehensive support for biopharmaceutical products from early development to clinical trials. We focus on optimizing formulations to ensure stability, efficacy, and safety. Key services include:
Lipid Screening:
- Selecting the best lipid compositions to enhance delivery and stability of therapeutic molecules, especially for lipid-based formulations like liposomes or lipid nanoparticles.
Nucleic Acid Cargo Integrity:
- Ensuring the integrity of nucleic acid payloads, such as mRNA or DNA, throughout the formulation process to maintain therapeutic effectiveness.
Particle Size and Size Distribution:
- Measuring and controlling the size and distribution of particles in formulations, which is crucial for drug delivery and bioavailability.
Lipid Quantitation:
- Precisely measuring lipid content in formulations to ensure consistency and optimal performance in lipid-based drug delivery systems.
Formulation Optimization:
- Refining the formulation process to improve drug solubility, stability, and release profile, ensuring maximum therapeutic benefit.
- Scale up and Process Development:
- Transitioning from lab-scale to large-scale manufacturing while ensuring consistency.
- Excipient Compatibility:
- Testing interactions between APIs and excipients for stability and efficacy.
- Solubility Screening:
- Evaluating compound solubility in various solvents to optimize formulation.
- Early Development:
- Creating initial formulations for preclinical studies, focusing on stability and bioavailability.
- Stability Studies:
- Assessing formulation stability under different conditions over time.
- Aggregation Studies:
- Preventing molecule aggregation in protein therapies to maintain quality.
- Force Degradation Studies:
- Identifying degradation pathways under stress to improve stability.
- Batch Manufacture for IND Studies:
- Producing compliant batches for IND applications.
Drug Delivery Technologies
Our drug delivery technologies focus on innovative methods to enhance the therapeutic effectiveness, bioavailability, and safety of pharmaceutical products. These advanced delivery platforms allow for precise targeting, sustained release, and improved patient outcomes.
Nanotechnology-Based Delivery:
- Lipid Nanoparticles (LNPs): Tiny particles made of lipids that encapsulate drugs, especially useful for delivering nucleic acids like mRNA. LNPs are highly effective in ensuring stability and delivery to target cells.
- Liposomes: Spherical vesicles with a lipid bilayer used to deliver both hydrophilic and hydrophobic drugs. Liposomes help improve bioavailability and reduce toxicity.
- Polymeric Nanoparticles: Nanometer-sized particles made of polymers that carry drugs to targeted areas. They offer controlled drug release and protect the drug from degradation.
- Polymeric Microspheres: Microscopic particles used to release drugs slowly over time, beneficial for sustained-release formulations.
- Micelles: Small spherical structures formed by amphiphilic molecules that encapsulate hydrophobic drugs, enhancing their solubility and stability.
- Lipid-Polymer Hybrid: A combination of lipid and polymer nanoparticles that improves the stability and controlled release of drugs.
- Polyplexes: Complexes formed by the combination of polymers with DNA or RNA, used for gene therapy and nucleic acid delivery.
- Emulsions: Mixtures of two immiscible liquids where one is dispersed in the other, used to deliver drugs with low solubility.
- Dendrimers: Highly branched, tree-like polymers that can encapsulate drugs, offering high precision in drug delivery and reduced toxicity.
Controlled Sustain Release Delivery:
- Technology designed to release drugs at a consistent and controlled rate over a prolonged period. This enhances patient compliance by reducing the frequency of dosing and maintains therapeutic levels of the drug in the bloodstream for longer durations.
Targeted Drug Delivery:
- Methods aimed at delivering drugs directly to specific cells or tissues in the body, minimizing off-target effects and maximizing therapeutic efficacy. This technology is especially useful in cancer treatment, where drugs are directed at tumor cells while sparing healthy tissues.
