Cell and Gene Therapies
Health Inspired, Quality Driven.
Supporting C> Product Manufacturers
Industry-leading solutions for every stage of the C> development process. Safeguarding people’s health requires bringing safe, high-quality, affordable and effective medicines to market. SGS boasts a wealth of Cell and Gene Therapy (C>) expertise. Our global team of specialists, working in cutting-edge facilities, provide much-needed support to leading manufacturers of C> products whether a cell therapy, viral vector, nucleic acid (DNA or RNA) product. The exceptional testing portfolio of SGS – underpinned by our key biopharmaceutical pillars of biosafety, characterization, bioanalysis and quality control– makes us the ideal partner for all your C> outsourcing needs.
SGS provides a range of testing solutions to help C> product manufacturers with:
Identification/design of the therapeutic vector and its structural characterization
Ensuring product safety and stability
Confirming quality and product consistency including support for raw and ancillary material analytics
Analyzing key purity markers
Verifying potency and therapeutic activity
Solutions to help organizations bring safe, effective products to market.
Ensuring Effective Therapeutic Cell and Gene Therapy The aim of a gene therapy is to treat diseases by replacing, inactivating, or introducing genes into a cell. Therapeutic vectors (viral, non-viral, and engineered) are the genetic material vehicles for modifying cells in the body (in vivo) or outside the body (ex vivo). Cells modified outside the body can be cultivated from the patient (autologous cells) or a donor (allogenic cells) and then administered as a cell therapy. SGS offers a wide range of regulatory compliant cell and gene therapy services to help clients creating effective therapeutic cells or vectors.
C> product manufacturers must identify the appropriate therapeutic vector and precisely define specific structural characteristics. SGS has a great deal of experience in this area, using techniques such as: • Analytical ultracentrifugation (AUC) to conduct quantitative analyses of the C> product’s macromolecules
• Nanoparticle tracking analysis (NTA) to visualize vector particle size and contraction • Resistive pulse sensing (RPS) to detect and measure the size of particles in fluid • Electron Microscopy for empty and full viral particles • DNA fingerprinting for cell therapy banks, products and vector cell substrates
Ensuring Product Safety
Adopt a safety-first approach C> product manufacturers face a major challenge in making sure their products are completely free from any harmful contaminants. SGS provide a range of services to address this critical safety issue, including:
• Bioburden and sterility analysis • Quantitation of endotoxin • Biosafety Testing. Detection and identification of adventitious agents • Characterisation of plasmid starting materials for vector production • Cell therapy characterisation and ICHQ5A / USP / Phar. Eur biosafety testing
SGS will work tirelessly to ensure that when you do bring a product to market, it is safe. Rest easy in the knowledge that you can focus on your core business activity while the experts at SGS leverage their broad analytical portfolio and unparalleled knowledge to safeguard the quality of the final product.
Confirming Quality and Product Consistency
Maintain exceptional standards at all times Ensuring product consistency can often be difficult, but it’s even more challenging when manufacturing C> products. These are highly engineered biological products that require a high level of product quality at both the early clinical manufacture stage and commercial scale production. Fortunately, SGS can aid manufacturers in confirming quality and product consistency throughout all stages of development by providing a broad range of services including:
• Development of titer assays to determine the concentration of viral particles. • Assess physicochemical characteristics such as osmolality and pH for both viral and non-viral mediated therapies. • Analysis of the critical quality attributes of viral vector, DNA, and RNA C> products
SGS specialists will act as safeguards, ensuring that your products always meet the necessary quality and consistency parameters. With these experts by your side, you can outsource the entire end-to-end process of confirming the ongoing quality and product consistency.
Analyzing Key Purity Markers CASE STUDY Identify potential contamination C> products must be free from all process and product-related biological and chemical contamination. SGS provides innovative solutions to identify any harmful contaminants which can highlight areas where product purity needs to be improved. SGS has a wealth of experience in techniques such as:
• Development of potency assays (MTS) to assess cell proliferation, cell viability, and cytotoxicity. • Detection of residual host cell DNA, RNA, and host cell proteins. • Advanced and sensitive chromatographic and mass spectrometry (MS) methods for the detection of process and product contaminants.
Our array of testing solutions will evaluate your product’s purity, underscoring issues that need to be addressed. They will also help you ensure it is free from extraneous material before it is assessed by regulators – and before it hits the market.
Verifying Potency and Therapeutic Activity CASE STUDY
Confirm your product’s efficacy C> products need to have the desired therapeutic effect. In vitro potency verification reveals the product’s therapeutic activity, demonstrating the impact that it will have when administered to a patient. SGS can help manufacturers easily assess their products true potency with a range of industry-leading services, including: • Cell-free assays for assessing C> product expression
• Manual or automated cell counting to verify the TNC count. • Flow cytometry to assess and quantitate antigen expression on cells. • Fluorescence and microscopy methods to detect viral antigens and visualize focal areas of infection. • Sensitive qPCR- or ELISA-based methods to detect of expression of gene therapy products in cell-based assays
Our innovative solutions, provided by experienced specialists working in state-of-the-art laboratories, allow the potency of your product to be accurately measured. Our trusted experts are up to date with the latest regulatory standards and industry best practices – making them the ideal partner for all your potency testing requirements.
Let’s Build a Healthier Future CASE STUDY
We are SGS – the world’s leading testing, inspection, and certification company, with decades of experience in the health and nutrition sector. SGS Health Science has one core mission: improving patient health by safeguarding the quality and efficacy of medicines.
SGS Health Science delivers industry-leading contract development and manufacturing (CDMO) and analytical development and testing to support you every step of the way as you deliver first-class, fully compliant biopharmaceutical and pharmaceutical drugs, clinical research, and medical devices. We are customer-centric, working hand-in-hand with our clients and providing services tailored to their specific needs.
By choosing SGS, you will be working with leading experts who will collaborate with you throughout every stage of your C> product’s development. You can leverage our industry-leading, fully accredited facilities featuring state-of-the-art equipment, and consult our knowledgeable specialists throughout the product development process.
DISCOVERY
DEVELOPMENT
POST-MARKETING
PRE-CLINICAL
LIFE CYCLE MANAGEMENT
PHASE I
PHASE II
PHASE III
Contract Development
Dose improvements & differentiation
Solid state characterization
Solubility enhancement
Bioavailability enhancement
Analytical Development and Testing
Stability
Release testing
CMC support
Characterization and biosafety
Contract Manufacturing
FIH supply
Microdosing
Process optimisation
PQ/PV/Commercial manufacturing
Clinical manufacturing, packing, supply and distribution Specials manufacturing
Clinical Research
Clinical pharmacology
Clinical trial management Biometrics Medical safety & regulatory
Bioanalysis Drug development consultancy
Health Science Health Inspired, Quality Driven.
Contact us
healthscience@sgs.com sgs.com/healthscience sgs.com/healthcommunity
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