Upstream Bioprocessing in Sudan
Engineering Excellence & Technical Support
Upstream Bioprocessing solutions for Bioprocessing & Manufacturing. High-standard technical execution following OEM protocols and local regulatory frameworks.
Sustainable Biocatalyst Development for Crop Yield Enhancement
Leveraging Sudan's diverse agricultural landscape and microbial resources, we are developing targeted biocatalysts (e.g., nitrogen-fixing bacteria, phosphate solubilizing fungi) to improve soil health and significantly boost the yield of staple crops like sorghum and millet, reducing reliance on synthetic fertilizers.
Advanced Bioremediation for Water Resource Management
Implementing innovative bioprocesses using locally sourced microbial consortia and plant-based systems for the efficient treatment of agricultural runoff and industrial wastewater. This technology aims to purify water sources, mitigate pollution, and promote sustainable water usage in arid and semi-arid regions of Sudan.
Bioreactor Optimization for Biofuel Production from Agricultural Waste
Developing and optimizing small-scale, modular bioreactor systems for the cost-effective conversion of agricultural residues (e.g., sugarcane bagasse, maize stover) into biofuels like ethanol and biogas. This initiative contributes to energy security and creates value-added products from waste streams in rural communities.
What Is Upstream Bioprocessing In Sudan?
Upstream bioprocessing in Sudan refers to the initial stages of biotechnological production involving the cultivation of biological agents (cells, microorganisms, enzymes) to produce desired biomolecules or products. This phase is characterized by the manipulation of living systems in controlled environments to achieve optimal growth and product formation. It encompasses all processes from the preparation of cell cultures and media to the actual fermentation or cell culture run, culminating in the harvesting of the biomass or secreted products.
| Who Needs Upstream Bioprocessing | Typical Use Cases | |||||
|---|---|---|---|---|---|---|
| Pharmaceutical companies (local and international operating in Sudan): For the production of biopharmaceuticals like vaccines, antibodies, therapeutic proteins, and recombinant enzymes. | Agricultural biotechnology firms: For the production of microbial inoculants, biopesticides, and enzymes used in animal feed. | Food and beverage industry: For the production of enzymes used in food processing (e.g., in baking, brewing, dairy), probiotics, and starter cultures for fermentation. | Research institutions and universities: For academic research, strain development, and proof-of-concept studies for new bioprocesses. | Environmental biotechnology companies: For the production of enzymes or microorganisms used in bioremediation or waste treatment. | Cosmetics industry: For the production of bio-actives and ingredients derived from microbial or cell culture processes. | |
| Production of recombinant proteins (e.g., insulin, growth hormones). | Development and manufacturing of monoclonal antibodies for therapeutic purposes. | Large-scale cultivation of microorganisms for enzyme production (e.g., amylases, proteases, lipases). | Production of microbial cell mass for direct use as probiotics or in food applications. | Fermentation processes for biofuels or biochemicals. | Cell culture for the production of viral vectors or other biological therapies. | Strain improvement and optimization studies for enhanced product yields. |
Key Components of Upstream Bioprocessing
- Inoculum preparation and scale-up: Generating a sufficient quantity and quality of microbial or cell culture to seed the production bioreactor.
- Media formulation and optimization: Designing and preparing sterile nutrient-rich media to support the growth and productivity of the biological agent.
- Bioreactor/Fermenter operation: Cultivating the biological agent under controlled conditions of temperature, pH, dissolved oxygen, agitation, and other parameters.
- Process monitoring and control: Continuously measuring and adjusting critical process parameters to maintain optimal conditions and ensure reproducibility.
- Cell harvesting or product recovery: Separating the biomass from the spent medium or recovering the desired product, which may be intracellular or extracellular.
Who Needs Upstream Bioprocessing In Sudan?
Upstream bioprocessing in Sudan, while still in its nascent stages, holds significant potential for specific sectors and stakeholders. It involves the initial stages of biopharmaceutical manufacturing, focusing on the cultivation of biological organisms (like cells or microorganisms) in bioreactors to produce desired products such as vaccines, antibodies, or enzymes. The application of these technologies can lead to greater self-sufficiency in essential medicines, agricultural advancements, and research capabilities within the country. Identifying the target customers and departments is crucial for fostering the development and adoption of upstream bioprocessing in Sudan.
| Customer Segment | Key Departments/Units Involved | Potential Applications & Needs |
|---|---|---|
| Pharmaceutical Companies (Local & International with Sudan Operations) | Research & Development (R&D), Manufacturing, Quality Control (QC), Production Planning | Production of monoclonal antibodies, recombinant proteins, vaccines, therapeutic proteins for chronic diseases. Need for reliable and cost-effective local production to reduce import reliance and improve accessibility. |
| Government Health Ministries & Agencies (e.g., Ministry of Health, National Medicines and Poisons Board) | Procurement, Public Health Programs, National Vaccine Programs, Drug Regulation & Quality Assurance | Securing supply chains for essential vaccines (e.g., polio, measles), insulins, and other biotherapeutics. Desire for reduced reliance on foreign aid and imports, and improved national health security. |
| Research & Development Institutions (Universities, National Labs, e.g., National Centre for Research) | Biotechnology Departments, Biochemistry Labs, Microbiology Labs, Medical Research Centers | Conducting basic and applied research in areas like disease diagnostics, novel drug discovery, and genetic engineering. Need for advanced equipment and expertise to support cutting-edge research and train future bioprocessing professionals. |
| Agricultural Biotechnology Companies | Crop Science R&D, Animal Health Divisions, Production Teams | Development of biopesticides, biofertilizers, enzymes for animal feed, and veterinary vaccines. Aiming to enhance agricultural productivity, improve food security, and reduce reliance on chemical inputs. |
| Food & Beverage Industry | Product Development, Quality Assurance, Production | Production of enzymes for food processing (e.g., baking, brewing, dairy), probiotics, and flavor enhancers. Seeking to improve efficiency and product quality through biocatalysis. |
| Veterinary Medicine Producers | R&D, Manufacturing, Quality Control | Production of veterinary vaccines, diagnostic kits, and therapeutic agents for livestock and poultry. Crucial for protecting animal health, which directly impacts food security and the livelihoods of farmers. |
| Biotech Start-ups & Entrepreneurs | R&D, Pilot Scale Production, Business Development | Developing innovative bioproducts and services. Require access to shared facilities, technical expertise, and investment to scale their operations from laboratory to commercial production. |
| Non-Governmental Organizations (NGOs) focused on health and agriculture | Program Implementation, Procurement, Technical Support Units | Facilitating access to affordable biopharmaceuticals and agricultural solutions in underserved communities. May partner with local manufacturers for cost-effective production and distribution. |
Target Customers and Departments for Upstream Bioprocessing in Sudan
- Pharmaceutical Companies (Local & International with Sudan Operations)
- Government Health Ministries & Agencies
- Research & Development Institutions (Universities, National Labs)
- Agricultural Biotechnology Companies
- Food & Beverage Industry (for enzyme production)
- Veterinary Medicine Producers
- Biotech Start-ups & Entrepreneurs
- Non-Governmental Organizations (NGOs) focused on health and agriculture
Upstream Bioprocessing Process In Sudan
Upstream bioprocessing in Sudan, like in other regions, involves a series of critical steps from initial inquiry to the final execution of cell culture and microbial fermentation to produce biological products. This process is fundamental for the manufacturing of biopharmaceuticals, vaccines, and other bio-based materials. The workflow is designed to ensure the production of high-quality, consistent, and scalable biological materials. It begins with a clearly defined requirement or research objective and culminates in the generation of cells or microbes at the desired density and physiological state, ready for downstream processing. Key considerations throughout the Sudan context would include local resource availability, regulatory frameworks, and the specific needs of the Sudanese biotechnology and healthcare sectors.
| Phase | Key Activities | Outputs | Considerations (Sudan Context) |
|---|---|---|---|
| Receive request/define research goal. Clarify product specifications, desired yield, and timeline. Initial feasibility assessment. | Clear understanding of project scope, objectives, and technical requirements. | Alignment with national health priorities, availability of local expertise for consultation, and initial budget allocation. |
| Design and refine the bioprocess. Identify optimal parameters (temperature, pH, dissolved oxygen, nutrient feeding). Develop protocols for media, inoculum, and bioreactor operation. | Optimized process parameters, detailed Standard Operating Procedures (SOPs), and preliminary yield estimates. | Leveraging existing research infrastructure, potential for collaboration with academic institutions, and resource-efficient media components. |
| Select the appropriate cell line (mammalian, insect, yeast, bacteria) or microbial strain. Characterize its growth kinetics, productivity, and genetic stability. Obtain necessary permits. | Well-characterized and stable cell/microbial stock, documented performance data. | Access to international cell banks, local strain isolation possibilities, and adherence to national biosafety regulations. |
| Prepare cell culture media or fermentation broth based on optimized formulations. Sterilize media to eliminate contaminants. | Sterile, nutrient-rich media ready for use. | Availability and cost of raw materials for media, reliable sterilization equipment, and water quality for media preparation. |
| Expand a small volume of the cell/microbial stock to generate a sufficient quantity for seeding the main bioreactor. Ensure the inoculum is healthy and at the correct cell density. | Healthy, viable inoculum at the desired concentration and volume. | Availability of appropriate growth media for inoculum expansion and aseptic handling techniques. |
| Prepare and sterilize the bioreactor or fermenter. Calibrate sensors and ensure all equipment is functioning correctly. | Sterile and fully operational bioreactor/fermenter. | Access to and maintenance of bioreactor technology, reliable power supply for sterilization and operation. |
| Introduce the prepared inoculum into the sterile bioreactor containing the prepared media. Initiate and maintain the defined process parameters. | Cultured cells or fermented microbes within the bioreactor. | Skilled personnel for aseptic inoculation and continuous operation, adherence to Good Manufacturing Practices (GMP). |
| Continuously monitor critical parameters (pH, temperature, dissolved oxygen, nutrient levels, cell density, product concentration). Adjust parameters as needed to maintain optimal conditions. | Real-time process data, logs of any interventions, and graphical representation of process performance. | Availability of reliable monitoring equipment, trained personnel for data analysis and intervention, and a system for data logging and archiving. |
| Once the desired cell density or product concentration is reached, harvest the culture. If the product is intracellular or cells need to be collected, perform cell separation. | Harvested biomass or clarified broth containing the desired product. | Appropriate harvesting and separation technologies, waste management protocols, and potential for value-added by-products. |
Upstream Bioprocessing Workflow in Sudan
- Inquiry & Requirement Definition
- Process Development & Optimization
- Cell/Microbial Strain Selection & Characterization
- Media Preparation & Sterilization
- Inoculum Preparation
- Bioreactor/Fermenter Setup & Sterilization
- Inoculation & Bioreactor Operation
- Process Monitoring & Control
- Harvesting & Cell Separation (if applicable)
Upstream Bioprocessing Cost In Sudan
Upstream bioprocessing costs in Sudan are a critical consideration for any biotechnology or pharmaceutical venture. These costs encompass the initial stages of biological product development, from cell line cultivation to fermentation and initial harvesting. Several factors influence these pricing structures, often influenced by the availability of specialized equipment, reagents, skilled labor, and energy. The local currency, the Sudanese Pound (SDG), is subject to significant fluctuations, which can impact the predictability and overall cost of these operations. Imported materials, a common necessity in bioprocessing, are particularly vulnerable to exchange rate volatility.
Key pricing factors include:
- Media and Reagents: The cost of cell culture media, growth factors, buffers, and other consumables varies significantly based on brand, purity, and supplier. Imported reagents often carry a premium due to import duties, shipping costs, and currency exchange rates.
- Cell Line and Inoculum: The initial investment in obtaining and maintaining a high-quality cell line or microbial inoculum can be substantial. This includes costs for cell banks, cryopreservation, and initial expansion.
- Equipment and Consumables: While major capital equipment (bioreactors, centrifuges, filtration systems) might be amortized over time, the ongoing costs of single-use consumables, sterile filters, tubing, and disposables are significant. Maintenance and calibration of existing equipment also contribute to the cost.
- Labor: Skilled personnel, including biotechnologists, microbiologists, and process engineers, are essential for upstream operations. Their salaries, benefits, and training represent a considerable portion of the operational budget.
- Energy and Utilities: Bioprocessing often requires consistent power for temperature control, agitation, and sterilization. The reliability and cost of electricity in Sudan can be a major factor. Water purification and sterile air supply also add to utility costs.
- Quality Control and Assurance: Rigorous testing at various stages of upstream processing to ensure product quality and consistency adds to the overall cost, including analytical reagents and equipment usage.
- Facility and Infrastructure: The cost of maintaining a sterile and controlled manufacturing environment, including HVAC systems, cleanroom certification, and waste disposal, is a direct component of upstream costs.
- Regulatory Compliance: Adhering to Good Manufacturing Practices (GMP) and other regulatory requirements adds costs through documentation, validation, and specialized training.
Pricing ranges are highly variable and depend on the scale of operation (laboratory, pilot, or commercial), the specific product being manufactured, and the chosen suppliers. As of late 2023/early 2024, direct, precise, and publicly available pricing data for specialized upstream bioprocessing in Sudan is scarce due to the niche nature of the industry and the dynamic economic environment. However, based on general observations of related industries and material costs, rough estimates can be inferred.
| Cost Component | Estimated Range (SDG) - Low | Estimated Range (SDG) - High | Notes |
|---|---|---|---|
| Cell Culture Media (per Liter) | 50,000 | 500,000+ | Highly dependent on complexity and formulation. Imported complex media will be at the higher end. |
| Sterile Filters (e.g., 0.22 micron, 25mm) | 2,000 | 15,000 | Per unit, price varies by brand, pore size, and supplier. |
| Disposable Pipette Tips (1000 units) | 5,000 | 25,000 | Affected by material quality and brand. |
| Basic Lab Reagents (e.g., PBS, Ethanol - per Liter) | 5,000 | 30,000 | Depends on purity grade and supplier. |
| Skilled Technician Salary (Monthly) | 150,000 | 600,000+ | Varies with experience and specialization. Includes benefits. |
| Electricity (per kWh - approximate industrial rate) | 50 | 200 | Highly variable due to subsidies and fuel costs. Reliability issues can add generator costs. |
| Small-scale Bioreactor (e.g., 1L, benchtop - purchase/amortization contribution) | 1,000,000 | 5,000,000+ | This is a simplified representation. Actual costs involve capital investment. |
| Basic Cell Line Maintenance (monthly) | 50,000 | 300,000 | Includes media, reagents, and basic consumables. |
Key Factors Influencing Upstream Bioprocessing Costs in Sudan
- Cell culture media and growth factors
- Antibiotics and antifungals
- Reagents for cell lysis and extraction
- Buffers and salts
- Sterile water and purification systems
- Cell line maintenance and expansion
- Inoculum preparation
- Single-use bioreactor bags and components
- Sterile filters (e.g., for air and liquid)
- Tubing and connectors
- Centrifuge tubes and consumables
- Disposables for sampling and transfer
- Cleaning and sterilization agents
- Skilled labor (technicians, scientists, engineers)
- Training and professional development
- Electricity for incubators, shakers, and HVAC
- Water treatment and purification costs
- Compressed air systems
- Analytical reagents for in-process testing
- Chromatography resins (if used in early purification stages)
- Equipment calibration and maintenance
- Rent or depreciation of laboratory/manufacturing space
- Waste disposal and environmental compliance
- Quality control testing reagents
- Documentation and validation materials
Affordable Upstream Bioprocessing Options
Affordable upstream bioprocessing is crucial for bringing cost-effective biotherapeutics to market. This involves strategically selecting technologies, optimizing processes, and leveraging innovative approaches to minimize expenses without compromising quality or yield. Key to achieving this is understanding and implementing value bundles and embracing various cost-saving strategies.
| Cost-Saving Strategy | Description | Impact on Upstream Bioprocessing |
|---|---|---|
| Scale-Up Optimization: | Carefully designing and executing scale-up to avoid inefficiencies and ensure consistent performance at larger volumes. | Reduces the number of failed or suboptimal batches, minimizing media and consumables waste, and optimizing equipment utilization. |
| Media Optimization: | Developing or selecting cost-effective, high-performance cell culture media that maximizes cell growth and product yield. | Directly reduces the largest variable cost in upstream processing (media) while improving productivity. |
| Single-Use Technologies (SUTs): | Adopting disposable bioreactors, bags, and other consumables to eliminate the need for cleaning, sterilization, and complex validation. | Lowers capital expenditure, reduces water and energy consumption, shortens turnaround times between batches, and minimizes cross-contamination risks. |
| Process Intensification: | Implementing strategies like perfusion or fed-batch cultures to achieve higher cell densities and product titers in smaller volumes or shorter timeframes. | Increases volumetric productivity, potentially reducing bioreactor size and associated capital and operational costs. |
| Automation & Digitalization: | Utilizing automated control systems, sensors, and data analytics for real-time monitoring and optimization. | Improves process consistency, reduces human error, enables predictive maintenance, and facilitates rapid troubleshooting, leading to fewer batch failures. |
| Strategic Sourcing & Vendor Negotiation: | Aggressively negotiating prices with suppliers for raw materials, consumables, and equipment, or consolidating purchases. | Directly lowers the cost of goods and can unlock bulk discounts. |
| Modular & Flexible Facility Design: | Designing facilities that can be easily reconfigured or scaled to accommodate different processes and volumes. | Reduces the need for costly retrofits and allows for efficient utilization of space and equipment. |
| Outsourcing Non-Core Activities: | Contracting out specific upstream tasks or entire processes to specialized CMOs. | Avoids significant capital investment in specialized equipment and expertise, allowing focus on core competencies. |
Value Bundles in Upstream Bioprocessing
- Technology Integration Bundles: Combining different technologies (e.g., bioreactors, cell culture media, single-use systems) from a single supplier or through strategic partnerships can lead to discounted pricing, streamlined procurement, and simplified integration.
- Process Development & Optimization Bundles: Services that encompass early-stage cell line development, media optimization, and initial process parameter definition, often offered as a package, can accelerate timelines and reduce the need for redundant experiments.
- Single-Use System Bundles: Purchasing a complete suite of single-use components (e.g., bags, tubing, connectors, filters) for a specific process scale can offer economies of scale and reduce capital expenditure on cleaning and sterilization.
- Analytical & QC Integration Bundles: Bundling upstream production with essential analytical testing and quality control services can ensure a seamless workflow and potentially reduce costs associated with independent service providers.
- Contract Manufacturing Organization (CMO) Bundles: CMOs often offer comprehensive upstream and downstream processing as a bundled service, providing access to expertise and infrastructure without the need for in-house investment.
Verified Providers In Sudan
In Sudan's evolving healthcare landscape, identifying reliable and credentialed healthcare providers is paramount. Franance Health stands out as a beacon of trust, meticulously vetting its network of medical professionals and facilities. This commitment to verification ensures that patients receive not only the best possible care but also the peace of mind that comes with knowing they are in expert hands. Franance Health's rigorous credentialing process focuses on several key areas, ensuring a high standard of medical expertise, ethical practice, and patient safety.
| Why Franance Health Credentials Matter | Benefits for Patients |
|---|---|
| Uncompromising Quality of Care: Our verified providers are demonstrably skilled and knowledgeable, leading to more accurate diagnoses and effective treatments. | Enhanced Patient Safety: Rigorous vetting minimizes the risk of substandard care or medical errors, prioritizing your well-being. |
| Access to Trusted Specialists: Franance Health connects you with specialists who have proven expertise in their fields. | Reduced Healthcare Anxiety: Knowing you're choosing a credentialed provider alleviates stress and uncertainty about your healthcare journey. |
| Ethical and Professional Practice: We ensure providers adhere to a strict code of ethics, fostering a respectful and trustworthy patient-provider relationship. | Empowered Healthcare Decisions: With Franance Health, you can make informed choices based on verified credentials and a commitment to excellence. |
| Streamlined Healthcare Navigation: Our network simplifies the process of finding reputable healthcare services in Sudan. | Peace of Mind: Ultimately, Franance Health's verification process offers the assurance that you are receiving care from the best available professionals. |
Franance Health's Credentialing Pillars
- Professional Licensure and Certification: Franance Health verifies that all participating healthcare providers hold current and valid licenses and certifications from recognized national and international bodies. This confirms their foundational qualifications and adherence to professional standards.
- Education and Training Verification: We meticulously review the educational background and specialized training of each provider, ensuring they possess the necessary expertise for their respective fields.
- Experience and Competency Assessment: Franance Health evaluates the practical experience and demonstrated competency of healthcare professionals through peer reviews, case studies, and performance metrics.
- Ethical Conduct and Disciplinary History: Providers undergo thorough background checks to ensure a clean disciplinary record and adherence to the highest ethical standards in medical practice.
- Facility Accreditation and Compliance: For partnered facilities, Franance Health confirms accreditation from relevant health organizations and adherence to strict safety, hygiene, and operational protocols.
Scope Of Work For Upstream Bioprocessing
This Scope of Work (SOW) outlines the technical deliverables and standard specifications for Upstream Bioprocessing activities. Upstream bioprocessing encompasses all stages from cell line development to the production of the target molecule in bioreactors. This document aims to define the expected outputs and quality standards for each phase, ensuring consistency, reproducibility, and compliance with relevant regulatory guidelines.
| Phase | Key Technical Deliverables | Standard Specifications/Acceptance Criteria |
|---|---|---|
| Cell Line Development | Stable, high-producing cell line exhibiting desired growth kinetics and productivity. Characterization data including genetic stability, phenotype, and expression levels. | Productivity ≥ X mg/L (specific target). Genetic stability confirmed by Southern blot or PCR. Phenotypic consistency demonstrated by growth rate and morphology. Absence of adventitious agents confirmed by viral testing. |
| Cell Banking | Master Cell Bank (MCB) and Working Cell Bank (WCB) vials meeting established quality standards. Certificates of Analysis (CoA) for each bank. | MCB/WCB vials viable at ≥ 90% post-thaw. Confirmed identity and purity of cells. Sterility and mycoplasma testing negative. Genetic stability confirmed. Virus safety testing according to ICH guidelines. |
| Media Preparation and Optimization | Defined or chemically defined cell culture media formulations optimized for the specific cell line and product. Sterile media batches meeting defined specifications. | Media components sourced from qualified vendors. pH, osmolality, and key nutrient concentrations within specified ranges. Sterility testing negative. Batch-to-batch consistency demonstrated. |
| Inoculum Train Development | Scalable inoculum expansion protocol to generate sufficient cell density for bioreactor seeding. Documentation of growth curves and cell viability at each stage. | Cell density ≥ Y x 10^6 cells/mL with viability ≥ 95% at the point of transfer to the production bioreactor. Growth rate maintained within target range. |
| Cell Culture/Fermentation | Production bioreactor runs achieving target cell density, viability, and product titer. Detailed batch records documenting all process parameters. | Target cell density ≥ Z x 10^6 cells/mL. Viability ≥ 85% at harvest. Product titer ≥ X mg/L. Process parameters (temperature, pH, dissolved oxygen, agitation, nutrient feeding) maintained within specified ranges ± tolerance. |
| Process Monitoring and Control | Real-time data logs for critical process parameters. In-process control (IPC) results for cell count, viability, metabolites (e.g., glucose, lactate, ammonia), and product concentration. | Data integrity and traceability. IPC results within pre-defined action limits. Deviations from setpoints addressed and documented. |
| Harvest and Initial Downstream Interface | Harvested cell broth or culture supernatant meeting initial purity and concentration requirements for downstream processing. Documentation of harvest procedures and yields. | Cell removal efficiency ≥ 95% (if applicable). Product concentration at harvest ≥ A mg/L. Absence of significant process-related impurities that would hinder downstream purification. pH and temperature controlled during harvest. |
Upstream Bioprocessing Phases and Key Activities
- Cell Line Development
- Cell Banking (Master Cell Bank, Working Cell Bank)
- Media Preparation and Optimization
- Inoculum Train Development
- Cell Culture/Fermentation in Bioreactors (Lab-scale, Pilot-scale, Commercial-scale)
- Process Monitoring and Control
- Harvest and Initial Downstream Processing Interface
Service Level Agreement For Upstream Bioprocessing
This Service Level Agreement (SLA) outlines the commitment of [Service Provider Name] ('Provider') to [Client Name] ('Client') regarding upstream bioprocessing services. It defines the expected response times for support requests and the guaranteed uptime for the managed bioprocessing systems and associated infrastructure.
| Service Component | Uptime Guarantee | Response Time (Critical Issue) | Response Time (Major Issue) | Response Time (Minor Issue) | Maintenance Window Notification |
|---|---|---|---|---|---|
| Bioreactor Systems (e.g., Cell/Microbial Culture Vessels, Media Preparation) | 99.5% | 1 hour | 4 hours | 8 business hours | 48 hours prior notice |
| Ancillary Equipment (e.g., Pumps, Sensors, Analyzers) | 99.0% | 2 hours | 6 hours | 12 business hours | 48 hours prior notice |
| Data Acquisition & Control Systems | 99.8% | 30 minutes | 2 hours | 6 business hours | 24 hours prior notice |
| Cloud/On-Premise Infrastructure (for data storage and remote access) | 99.9% | 1 hour | 4 hours | 8 business hours | 48 hours prior notice |
Key Definitions
- Uptime: The percentage of time the bioprocessing system is available and operational for use by the Client. This excludes scheduled maintenance and force majeure events.
- Response Time: The maximum time elapsed from the initiation of a support request by the Client to the initial acknowledgement and diagnosis by the Provider.
- Downtime: Any period during which the bioprocessing system is unavailable or not operational.
- Critical Issue: An issue that completely halts or severely impairs the primary bioprocessing function, leading to immediate production stoppage or significant loss of product viability.
- Major Issue: An issue that significantly degrades performance or functionality but does not completely halt the primary bioprocessing function. May lead to reduced yield or quality.
- Minor Issue: An issue that affects non-critical functionality or user interface, with minimal impact on the primary bioprocessing function or production.
- Scheduled Maintenance: Pre-planned maintenance activities that are communicated to the Client in advance and are performed during agreed-upon maintenance windows.
Frequently Asked Questions
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