Our Services
We offer solutions for diverse synthetic chemistry challenges, drawing on our expertise and deep understanding of drug discovery and development.
Medicinal Chemistry
At Symmetry Biosciences, we recognize the indispensable role of medicinal chemistry in expediting drug discovery timelines. Using visualization and modeling software coupled with synthetic techniques, our expert chemists meticulously design and optimize compounds for enhanced potency, stability, and patentability.
Process Chemistry
Our tailored approach ensures efficient, cost-effective processes, prioritizing safety, sustainability, and customer satisfaction. Partner with us for reliable innovation and success in process development, ensuring the success of your drug candidate.
With over a decade of experience, we specialize in all phases of process development, offering tailored solutions to meet your project's needs. From route selection to technical transfer, our services are designed to optimize efficiency and reduce costs. We prioritize safety, sustainability, and customer satisfaction, delivering robust processes within budget and timeline constraints.
Our commitment to innovation drives us to continuously improve processes, minimizing reliance on column chromatography and maximizing environmental friendliness.
Analytical & Bioanalytical Services
At Symmetry Biosciences, we are committed to delivering industry-leading analytical and bioanalytical services that empower our clients in the pharmaceutical, biotechnology, and chemical sectors. Our mission is to provide precise, reliable, and timely results through cutting-edge technology and expert collaboration, ensuring the success and safety of your products at every stage of development.
Our Analytical Services
1. Analytical Development
Objective:
In the pharmaceutical and biotechnology sectors, analytical development is essential to ensure that products meet the highest standards of quality, safety, and efficacy. At Symmetry Biosciences, we focus on developing and validating analytical methods that are integral to the entire lifecycle of drug development, from discovery through post-market surveillance.
Services Offered:
- Method Development: Our team specializes in creating robust and reliable analytical methods using advanced techniques such as Ultra/High-Performance Liquid Chromatography (U/HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS). These methods are designed to accurately quantify drug potency, detect impurities, and evaluate stability.
- Stability-Indicating Methods: We develop stability-indicating methods that are crucial for assessing the shelf life and storage conditions of pharmaceutical products. These methods help in identifying potential degradation products and ensuring that the product remains safe and effective throughout its intended use.
- Potency and Related Substances: We are experienced in developing methods to measure the potency of active pharmaceutical ingredients (APIs) and their related substances. This includes monitoring potential contaminants, degradation products, and by-products that could impact the safety and efficacy of the drug.
- Validation Services: Our rigorous validation process ensures that all analytical methods we develop are accurate, precise, reproducible, and compliant with industry standards. We validate methods according to International Council for Harmonization (ICH) guidelines, ensuring that your products meet regulatory requirements.
- Comprehensive Reporting: Each analytical method development and validation project culminates in a detailed report, including method parameters, validation results, and recommendations for routine use.
2. Analysis and Methods
At Symmetry Biosciences, we offer a wide range of analytical testing services to support your research and development needs. Our services are designed to provide you with accurate and reliable data to guide your decision-making process.
Analytical Methods & Techniques:
- Drug Load Analysis (HPLC Assay): We perform high-performance liquid chromatography (HPLC) assays to determine the drug load in pharmaceutical formulations. This analysis is critical for ensuring that the active ingredient is present at the correct dosage and is uniformly distributed throughout the formulation.
- Particle Size and Volume Distribution (Laser Diffraction): Using laser diffraction technology, we measure the particle size distribution of powders and granules. This information is essential for understanding the physical properties of the drug product, which can influence its bioavailability and stability.
- Residual Solvent Analysis (Gas Chromatography): Residual solvents are impurities that can remain in pharmaceutical products after manufacturing. We use gas chromatography (GC) to detect and quantify these solvents, ensuring that they are within acceptable limits as defined by regulatory guidelines.
- In Vitro Release Testing (Shaker Bath or USP II/IV Apparatus, HPLC Assay): In vitro release testing is used to measure the rate and extent of drug release from a dosage form. We offer a variety of testing methods, including shaker bath and USP Apparatus II/IV, combined with HPLC assays, to provide a comprehensive evaluation of your product’s performance.
Full Range of Analytical Testing Capabilities:
- HPLC & UHPLC: Our HPLC and UHPLC systems are equipped with a wide range of detectors, including UV, PDA, and fluorescence, allowing us to perform complex separations and analyses with high sensitivity and accuracy.
- Gas Chromatography (GC): We offer GC services for the separation and analysis of volatile compounds. Our GC systems are coupled with flame ionization detectors (FID) and mass spectrometers (MS) for enhanced detection capabilities.
- Gel Permeation Chromatography (GPC): GPC, also known as size exclusion chromatography, is used to analyze the molecular weight distribution of polymers. This technique is crucial for characterizing the physical properties of materials in drug formulations.
- In Vitro Dissolution Testing: Dissolution testing is a key quality control measure for oral solid dosage forms. We offer a range of dissolution testing services to assess the release characteristics of your drug product under various conditions.
- Laser Diffraction Particle Sizing: Accurate particle size analysis is essential for product formulation and quality control. Our laser diffraction technology provides precise measurements of particle size and distribution.
- Differential Scanning Calorimetry (DSC): DSC is used to study the thermal properties of materials, including melting points, crystallization, and glass transition temperatures. This information is vital for understanding the stability and compatibility of pharmaceutical excipients and APIs.
- UV/Vis Spectroscopy: We offer UV/Vis spectroscopy services for the quantitative analysis of a wide range of compounds. This technique is particularly useful for assessing the concentration of APIs and excipients in solution.
- Karl Fischer Titration: Water content analysis is critical for the stability of pharmaceutical products. We provide Karl Fischer titration services to accurately measure the moisture content in your formulations.
- External Services (LC/MS, GC/MS, NMR): For specialized analysis, we collaborate with external partners to provide LC/MS, GC/MS, and Nuclear Magnetic Resonance (NMR) spectroscopy services. These techniques are used for detailed structural elucidation and quantitative analysis of complex molecules.
3. Bioanalytical Testing Services
Symmetry Biosciences offers an extensive range of bioanalytical testing services, designed to meet the diverse needs of clients in the pharmaceutical, biotechnology, and nutraceutical industries. Our services are tailored to provide precise and reliable data, supporting the development and commercialization of your products.
Bioanalytical Testing Capabilities:
Small Molecule Analysis: We specialize in the analysis of small molecules, which are a cornerstone of many pharmaceutical products.
Our services include:
- Enzyme Activity Assays: We offer enzyme activity assays for various biological molecules, including proteases, phytases, and carbohydrate hydrolases. These assays are essential for understanding the mechanism of action and potency of enzyme-based therapeutics.
- Nutrient Analysis: Using LC-MS and UPLC, we accurately quantify nutrients such as amino acids, organic acids, carbohydrates, and lipids in biological samples. This data is crucial for assessing the nutritional content of food and nutraceutical products.
- Protein Assays: Our protein analysis services include:
- Protein Purification: We utilize advanced liquid chromatography techniques to purify proteins from complex mixtures. This service is essential for researchers working with recombinant proteins, antibodies, and other biologics.
- Immunoassays (ELISA): Enzyme-Linked Immunosorbent Assay (ELISA) is a powerful tool for detecting and quantifying specific proteins in biological samples. We offer custom ELISA development and validation to meet your research needs.
- Genetic Analysis: Our genetic analysis services provide valuable insights into gene expression and genetic variability:
- Quantitative PCR (qPCR): qPCR is a sensitive and precise technique for quantifying gene expression levels in biological samples. We offer tailored qPCR assay development for specific biomarkers, ensuring accurate and reproducible results.
- Tailored Assay Development: Our team can develop custom assays to target specific genetic markers or mutations. These assays are valuable for applications in personalized medicine, biomarker discovery, and genetic screening.
- Elemental Analysis: Using Inductively Coupled Plasma Mass Spectrometry (ICP-MS), we detect and quantify elemental compositions, including heavy metals, in biological and environmental samples. This service is critical for ensuring product safety and compliance with regulatory standards.
- Method Development and Validation: Our bioanalytical method development and validation services are tailored to meet the specific needs of your project:
- Custom Assay Development: We work closely with our clients to develop assays that are specific to their biomarkers and compounds of interest. This includes the optimization of assay conditions to ensure maximum sensitivity and specificity.
- Validation Services: We rigorously validate our assays to ensure they meet the highest standards of accuracy, precision, and reproducibility. Our validation process includes a thorough evaluation of assay performance characteristics, including linearity, limit of detection (LOD), limit of quantification (LOQ), and robustness.
- Regulatory Compliance: At Symmetry Biosciences, we understand the importance of regulatory compliance in the bioanalytical testing process. Our methods are developed and validated following the latest regulatory guidelines, ensuring that your data is reliable and acceptable to regulatory authorities.
- Collaborative Research and Development: We believe in the power of collaboration to drive innovation. Our team works closely with clients to develop tailored R&D solutions that meet the unique needs of their projects. Whether you’re developing a new drug, improving an existing product, or exploring new therapeutic targets, Symmetry Biosciences is your innovation partner.
Analysis and Methods
| Analysis | Method |
|---|---|
| Drug Load | HPLC Assay |
| Particle Size and Volume Distribution | Laser Diffraction |
| Analysis | Method |
|---|---|
| Residual Solvent | Gas Chromatography |
| In Vitro Release | Shaker Bath or USP II/IV Apparatus, HPLC Assay |
Full Range of Analytical Testing Capabilities:
- HPLC
- UHPLC
- GC
- GPC
- In vitro dissolution
- Laser diffraction particle sizing
- DSC
- UV/Vis
- Karl Fischer
- LC/MS (external)
- GC/MS (external)
- NMR (external)
- Characterization of Drug Formulations: NMR, GPC, HPLC, MALDI TOF, TLCs
- In-vitro and In-vivo Testing
- Stability Studies
- Lyophilization
Whether you have limited or fully validated methods developed for your product, Symmetry Biosciences can assist. Contact our team today to learn how we can initiate a seamless method transfer and begin developing robust analytical methods with quick turnarounds for your product.
| Small Molecule | Fluorophores |
| Oligonucleotides synthesis | Amino acids |
| Asymmetric synthesis | Biotinalyated products |
| Carbohydrates | Glucuronides |
| Heterocycles | Bioconjugates |
| Natural product synthesis | Metabolite synthesis (Phase I and II) |
| Privileged scaffold synthesis | Boronic acids |
| Phospholipids | Stable isotopically labeled compounds (2H, 13C, 15N) |
| Peptides (solution and solid phase) |
| UPLC, HPLC & Preparative HPLC | Small Biomolecule Analysis: Nutrient quantification and assessment. |
| CHN Analysis | Large Biomolecule Analysis: Enzyme activity assays and custom ELISA development. |
| NMR | Genetic Analysis: qPCR and tailored assay development for precise gene expression insights. |
| LCMS | Elemental Analysis: Ensuring safety through ICP-MS for heavy metal detection. |
| MALDI-TOF (MS) | Custom Method Development and Validation: Tailored assays meeting regulatory compliance. |
| TGA | Cannabinoid Profile & Potency Testing |
| ICP-MS | Residual Solvents and Impurities |
| FT-IR Spectrophotometer | Pesticide Residue Analysis |
| Headspace GC | Foreign Matter Analysis |
| Auto-Titrator & KF Apparatus | Heavy Metals Analysis |
| Stability Studies | Moisture Analysis |
GMP Services
Symmetry Biosciences' GMP Lab: Your Partner in Excellence
At Symmetry Biosciences, our Good Manufacturing Practice (GMP) lab epitomizes our unwavering commitment to quality, compliance, and innovation in the life sciences industry.
Our GMP Services
- Research & Development: Propel your product innovation with our cutting-edge R&D capabilities, designed to accelerate discovery and development.
- Quality Control: Leverage our rigorous testing protocols to ensure unparalleled product safety and efficacy.
- Scalable Production: From milligrams to kilograms, we provide flexible production solutions that scale with your needs.
- Regulatory Compliance: Count on our strict adherence to GMP regulations and guidelines, ensuring seamless regulatory approval processes.
- Equipment Verification: Achieve precision and reliability through our thorough equipment verification procedures.
- Technology Transfer: Benefit from smooth transitions from development to production with our comprehensive technology transfer services.
- Process Validation: Maintain product consistency and quality with our meticulous process validation.
- IND Submission Support: Navigate the regulatory landscape with our expert support for Investigational New Drug (IND) submissions to the FDA.
Specialized Chemistry Services
Oligonucleotide Synthesis
Oligonucleotides (oligos) are short, single-stranded DNA or RNA molecules used in a variety of fields including biochemistry, genomics, and molecular diagnostics. They can be unmodified or chemically modified for specific applications, such as adding phosphate groups for ligation, labeling with probes, or incorporating reactive moieties for coupling with other molecules.
Symmetry Biosciences is equipped with a highly skilled team and state-of-the-art facility for oligonucleotide synthesis and analysis. We specialize in custom synthesis of various oligonucleotides, such as antisense oligonucleotides, siRNA, and aptamers, tailored to your specifications. Our services encompass thorough testing for purity, structure, and stability, ensuring precise, reproducible, and efficient delivery of top-quality results.
Electrochemistry
Electrosynthesis processes can often be run under milder operating conditions with fewer chemical reagents. At Symmetry Biosciences, we handle different reactions that can be carried out electrochemically include Nitro Reduction, Halogenation, Methoxylation, Acetoxylation, Hydrogenation, Carboxylation & Decarboxylation, Coupling Reactions, Acetamidation, Dehalogenation and Cyanation.
Control Substances
Controlled substances come with strict rules to ensure they’re handled safely and responsibly. This includes special requirements for how they're bought, stored, secured, tracked, disposed of, and moved in or out of the country. It is imperative to find a company with the experience and license approvals to handle controlled substance APIs. At Symmetry Biosciences we have licenses for Schedule I to VI. Our company ensures strict compliance with regulations for controlled substances across Schedules I through V:Â
Nucleoside/Nucleotide
We offer customized synthesis of Nucleosides/Oligonucleotides, including antisense oligonucleotides, siRNA, and aptamers, tailored to your specific needs. Our comprehensive services include rigorous testing for purity, structural integrity, and stability, ensuring high accuracy and reproducibility. We are committed to delivering high-quality, efficient solutions for all your oligonucleotide needs.
Lipids, Peptides and Carbohydrates
Lipids play a key role in cosmetics, food, and advanced drug delivery systems, including the successful Covid-19 vaccines. We offer a diverse range of advanced lipid molecules, such as ionizable lipids, cationic lipids, phospholipids, PEG lipids, and cholesterol, to clients around the globe. Additionally, we provide rapid custom synthesis of novel lipid molecules to support cutting-edge research in the pharmaceutical and biotech industries.Â
Peptides are recognized for their high specificity and efficacy, allowing for selective targeting with minimal side effects. Symmetry Biosciences is a leader in this domain, offering expert peptide synthesis and a broad array of complementary synthesis services. We provide tailored, comprehensive solutions to meet your unique needs.
Reference Markers, Standards, Metabolites and Isotope Labelled compounds
We provide comprehensive synthesis services to support your development processes, including:
- Synthesis of reference standards and impurities for analytical work, toxicology studies, and regulatory submissions.
- Production of metabolites for efficacy and toxicity testing.
- Creation of stable isotope metabolites (deuterium, 13C, 15N, and 18O) to optimize in vivo applications and metabolic flux analyses.
- Development of stable isotope APIs and intermediates (deuterium, 13C, 15N, and 18O) for pharmacokinetic studies.
Our services are designed to enhance your research and development efforts with precision and efficiency.