Verified Service Provider in Cabo Verde
Upstream Bioprocessing in Cabo Verde
Engineering Excellence & Technical Support
Upstream Bioprocessing solutions for Bioprocessing & Manufacturing. High-standard technical execution following OEM protocols and local regulatory frameworks.
Optimized Fermentation for Novel Biopharmaceuticals
Leveraging advanced bioreactor designs and real-time process monitoring to maximize yield and purity of therapeutic proteins, addressing unmet medical needs in Cabo Verde.
Scalable Cell Culture Systems for Sustainable Production
Implementing robust and energy-efficient cell culture platforms that minimize water usage and waste generation, aligning with Cabo Verde's commitment to environmental sustainability.
Data-Driven Process Analytics for Enhanced Bioprocess Control
Utilizing machine learning algorithms and cloud-based data platforms to predict and control critical process parameters, ensuring consistent product quality and regulatory compliance for biopharmaceutical manufacturing in Cabo Verde.
What Is Upstream Bioprocessing In Cabo Verde?
Upstream bioprocessing in Cabo Verde refers to the initial stages of the biotechnological production process, focusing on the growth and maintenance of biological agents (e.g., microbial cells, mammalian cells, plant cells, enzymes) under controlled conditions to achieve a desired biomass or product concentration. This phase encompasses the selection and preparation of the biological system, media formulation and sterilization, inoculum development, and the cultivation itself within bioreactors or other growth vessels. The primary objective of upstream processing is to generate a sufficient quantity of high-quality biological material for downstream purification and final product recovery. In the context of Cabo Verde, where investment in and development of the biotechnology sector are emerging, upstream bioprocessing services are crucial for enabling local production of biopharmaceuticals, industrial enzymes, biofertilizers, biofuels, and other bio-based products.
| Who Needs Upstream Bioprocessing Services? | Typical Use Cases in Cabo Verde | ||||
|---|---|---|---|---|---|
| Biotechnology startups and research institutions in Cabo Verde developing novel bio-based products. | Production of recombinant proteins (e.g., therapeutic antibodies, enzymes) for pharmaceutical applications. | Companies involved in the development of biofertilizers and biopesticides for the agricultural sector. | Manufacturers of industrial enzymes used in food processing, textiles, and detergent industries. | Entities exploring the production of biofuels from microbial or algal sources. | Research groups investigating novel microbial applications for environmental remediation. |
Key Components of Upstream Bioprocessing
- Strain/Cell Line Development and Selection
- Media Preparation and Sterilization
- Inoculum Train Development
- Bioreactor/Fermenter Operation
- Process Monitoring and Control (pH, temperature, dissolved oxygen, nutrient levels)
- Biomass Harvesting (for cell-based products)
Who Needs Upstream Bioprocessing In Cabo Verde?
Upstream bioprocessing, the initial stages of biological product manufacturing involving cell culture, fermentation, and media preparation, plays a crucial role in various industries. In Cabo Verde, while the biopharmaceutical sector is nascent, there are emerging and potential areas where expertise in upstream bioprocessing is and will be increasingly valuable. This document outlines the target customers and relevant departments that would benefit from and contribute to advancements in upstream bioprocessing in Cabo Verde.
| Industry Sector | Potential Applications of Upstream Bioprocessing | Key Departments Involved |
|---|---|---|
| Biopharmaceutical/Biotech | Vaccine production, therapeutic protein manufacturing, monoclonal antibody development, diagnostic reagent production | R&D, Process Development, Manufacturing, QC/QA |
| Research & Academia | Fundamental biological research, development of new biological tools, pilot-scale production for studies | Research Labs (Microbiology, Molecular Biology), Process Development |
| Agriculture & Food | Probiotic development, biofertilizer production, biopesticide manufacturing, fermentation for food/beverage, animal feed enhancement | R&D, Production, Quality Control |
| Environmental Services | Microbial consortia for wastewater treatment, bioremediation agents, biosurfactant production | R&D, Process Development, Operations |
| Diagnostics | Production of enzymes and antibodies for diagnostic kits, development of biosensors | R&D, Production, QC |
Target Customers and Departments for Upstream Bioprocessing in Cabo Verde
- {"items":["Pharmaceutical and Biotechnology Companies (Emerging/Future): Companies involved in the development and production of biopharmaceuticals, vaccines, therapeutic proteins, and diagnostic kits. This includes both local startups and potentially foreign entities looking to establish or expand their presence in Cabo Verde.","Research Institutions and Universities: Academic and governmental research bodies focused on life sciences, health, agriculture, and environmental science. They may require upstream capabilities for research, development, and pilot-scale production of biological agents or products.","Agricultural and Food Production Sector: Industries involved in fermentation processes for food and beverage production (e.g., brewing, yogurt production), as well as potentially for the development of biofertilizers, biopesticides, and animal feed additives.","Environmental Monitoring and Remediation Agencies: Organizations involved in using or developing microbial solutions for water treatment, waste management, and bioremediation. Upstream expertise is needed for cultivating and scaling up these microbial consortia.","Diagnostic Laboratories: Laboratories developing or utilizing biosensors and diagnostic tools that rely on biological components, which may require small-scale upstream production.","Government Ministries and Agencies: Particularly those related to health, agriculture, environment, and science and technology, who would be interested in fostering local capacity and innovation in bioprocessing."],"title":"Target Customers"}
- {"items":["Research and Development (R&D) Departments: Responsible for the discovery and early-stage development of new biological products, requiring experimental upstream processes.","Process Development and Scale-Up Departments: Focus on optimizing and scaling upstream processes from laboratory to pilot and commercial scales.","Manufacturing and Production Departments: Directly involved in the day-to-day operations of upstream bioprocessing, including cell culture, fermentation, and media preparation.","Quality Control (QC) and Quality Assurance (QA) Departments: Ensuring the consistency, safety, and efficacy of biological products produced through upstream processes.","Microbiology and Molecular Biology Labs: Within research institutions or companies, these labs often handle microbial cultivation and genetic engineering, which are core to upstream bioprocessing.","Bioprocess Engineering Teams: Dedicated teams focused on the design, implementation, and optimization of bioprocessing equipment and workflows.","Environmental Services/Labs: For agencies focused on using or developing biological solutions for environmental applications.","Agricultural Research Divisions: Within agricultural ministries or research institutes, focusing on bio-inputs or improved crop/animal production methods."],"title":"Relevant Departments/Divisions within Target Customers"}
Upstream Bioprocessing Process In Cabo Verde
The upstream bioprocessing workflow in Cabo Verde, like in many regions, encompasses a structured series of steps from the initial customer inquiry to the final execution of bioprocess development and production. This process is crucial for the successful development and scaling of biological products, whether they are pharmaceuticals, industrial enzymes, or agricultural bio-products. Understanding this workflow is essential for any entity seeking bioprocessing services or establishing biomanufacturing capabilities in Cabo Verde. The typical stages involve detailed planning, robust experimental design, careful execution, and thorough analysis, ensuring quality, efficiency, and regulatory compliance.
| Stage | Description | Key Activities in Cabo Verde Context | Potential Challenges/Considerations in Cabo Verde |
|---|---|---|---|
| Inquiry and Initial Consultation | The client or interested party contacts the bioprocessing provider to discuss their project needs. | Understanding the specific product, target yield, desired timeline, and regulatory requirements. Discussion of potential local expertise and resources available in Cabo Verde. | Ensuring clear communication channels, potentially across different time zones and languages. Identifying the right point of contact for local regulatory bodies. |
| Project Scoping and Feasibility Assessment | Detailed understanding of the project's technical, economic, and regulatory feasibility. | Assessing the suitability of existing cell lines/strains, preliminary cost estimates for raw materials and labor, and an initial review of regulatory pathways relevant to Cabo Verde or target markets. | Availability and cost of specialized reagents and equipment. Understanding local infrastructure limitations (e.g., power stability, internet connectivity). |
| Proposal Development and Agreement | Formal document outlining the project scope, methodology, deliverables, timeline, and costs. Once accepted, a contract is signed. | Tailoring the proposal to reflect local operational costs and regulatory considerations. Highlighting any unique advantages of operating in Cabo Verde (e.g., specific government incentives). | Navigating legal and contractual complexities. Ensuring clear payment terms and intellectual property protection. |
| Strain/Cell Line Development and Characterization | Selection, engineering, and rigorous testing of the biological entity (microorganism or cell) for optimal production. | If indigenous strains are to be used, this involves collection and characterization. If imported, ensuring compliance with import regulations for biological materials into Cabo Verde. | Access to advanced molecular biology labs and expertise. Importation of specialized growth factors or genetic modification tools. |
| Media Optimization and Development | Designing and testing growth media to maximize cell growth and product yield. | Sourcing cost-effective and readily available raw materials for media preparation within Cabo Verde. Adapting formulations to local water quality if applicable. | Availability and consistency of high-purity raw materials. Potential need for local sourcing and quality control of these materials. |
| Process Development and Optimization (Lab Scale) | Conducting experiments in small-scale bioreactors to establish optimal growth conditions (temperature, pH, dissolved oxygen, feeding strategies). | Utilizing lab facilities that meet international standards. Documenting every parameter meticulously for reproducibility. | Availability of highly skilled personnel for experimental design and execution. Managing waste disposal from laboratory experiments according to local environmental regulations. |
| Scale-Up Studies | Gradually increasing the bioreactor volume to identify and address challenges associated with larger scales. | Simulating potential scale-up challenges in a controlled environment before moving to pilot scale. This might involve assessing mixing and mass transfer at different volumes. | Access to intermediate-scale bioreactors and the expertise to operate them. Ensuring utilities (e.g., compressed air, steam) can support larger vessels. |
| Pilot-Scale Manufacturing | Producing the product in a small-scale manufacturing environment to validate the process and generate material for testing. | This phase is critical for demonstrating the robustness and reproducibility of the process under conditions that mimic full-scale manufacturing. It also generates data for regulatory submissions. | Availability of pilot-scale facilities. Hiring and training local operators. Ensuring compliance with Good Manufacturing Practices (GMP) if the product is for pharmaceutical use. |
| Technology Transfer and Validation | Transferring the developed process to a larger manufacturing facility and validating its performance. | If manufacturing is to occur in Cabo Verde, this involves training local teams and validating the process in the full-scale facility. If the process is transferred elsewhere, it involves comprehensive documentation and training. | Ensuring the receiving facility has the necessary infrastructure, equipment, and trained personnel. Regulatory approval for the transferred process. |
| Routine Manufacturing (if applicable) | Ongoing production of the product at a commercial scale. | Implementing strict quality control measures and standard operating procedures. Continuous process monitoring and optimization for efficiency. | Ensuring a stable and reliable supply chain for raw materials and consumables. Maintaining consistent product quality and meeting market demand. |
| Quality Control and Assurance | Implementing robust testing and monitoring throughout the entire process to ensure product safety, efficacy, and consistency. | Establishing a dedicated QC/QA team. Implementing analytical methods suitable for the product and compliant with relevant standards. Periodic audits and regulatory inspections. | Availability of certified analytical laboratories and qualified QC personnel. Compliance with international quality standards and local regulatory requirements. |
| Project Closure and Reporting | Finalizing all project documentation, reporting on outcomes, and formally closing the project. | Compiling all experimental data, process reports, and financial summaries. Providing a comprehensive final report to the client. | Ensuring timely delivery of all documentation and adherence to contractual obligations. |
Upstream Bioprocessing Workflow in Cabo Verde
- Inquiry and Initial Consultation
- Project Scoping and Feasibility Assessment
- Proposal Development and Agreement
- Strain/Cell Line Development and Characterization
- Media Optimization and Development
- Process Development and Optimization (Lab Scale)
- Scale-Up Studies
- Pilot-Scale Manufacturing
- Technology Transfer and Validation
- Routine Manufacturing (if applicable)
- Quality Control and Assurance
- Project Closure and Reporting
Upstream Bioprocessing Cost In Cabo Verde
Upstream bioprocessing, the initial stages of producing biological products, involves a range of costs in Cabo Verde. These costs are influenced by factors such as the scale of operation, the specific bioprocess being implemented, the source and availability of raw materials, labor costs, regulatory compliance, and the technological sophistication employed. Due to Cabo Verde's island status and reliance on imports for many specialized materials and equipment, upstream bioprocessing can be subject to higher logistical and import-related expenses compared to mainland economies. Pricing is typically discussed in the local currency, the Cape Verdean Escudo (CVE).
| Bioprocessing Component/Activity | Estimated Cost Range (CVE) | Notes |
|---|---|---|
| Basic Growth Media (per liter) | 1,000 - 5,000+ | Highly variable based on complexity and source. Import dependence is a major factor. |
| Small-scale Bioreactor (e.g., 5-20L, for R&D) | 1,500,000 - 5,000,000+ | Includes basic instrumentation. Higher-end models are significantly more expensive. Installation and calibration add to costs. |
| Sterile Room Setup (basic, per square meter) | 50,000 - 200,000+ | Depends on the class of cleanroom required. Significant upfront investment. |
| Skilled Technician (monthly salary) | 60,000 - 150,000+ | Varies based on experience and qualifications. May include social security contributions. |
| Electricity (per kWh) | 20 - 40+ | Subject to fluctuations in fuel prices. Island grids can sometimes be less stable. |
| Water (per cubic meter, industrial rate) | 100 - 300+ | Availability and purification needs influence cost. |
| Regulatory Consultation/Permitting (initial) | 200,000 - 1,000,000+ | Can vary greatly depending on the complexity of the product and regulatory pathway. |
| Import Duties/Tariffs (percentage of CIF) | 5% - 30%+ | Applied to imported equipment and consumables. Specific rates depend on the product category. |
Key Pricing Factors for Upstream Bioprocessing in Cabo Verde
- Raw Material Sourcing: Availability and cost of growth media, carbon/nitrogen sources, trace elements, and other biological reagents. Import duties and shipping can significantly inflate these costs.
- Equipment and Infrastructure: Investment in bioreactors, fermenters, centrifuges, filtration systems, sterile environments (cleanrooms), and supporting utilities. Maintenance and calibration costs are also relevant.
- Labor and Expertise: Salaries for skilled technicians, researchers, and quality control personnel. The availability of local expertise can influence training requirements and associated costs.
- Energy and Utilities: Costs associated with electricity (often generated from imported fuels), water, and waste disposal. Energy reliability can also impact operational efficiency and costs.
- Regulatory Compliance: Costs related to obtaining permits, adhering to Good Manufacturing Practices (GMP), quality assurance, and documentation. These can be substantial, especially for pharmaceutical or food-grade products.
- Scale of Production: Larger-scale operations generally benefit from economies of scale, leading to lower per-unit costs. However, initial capital investment is higher.
- Logistics and Import Costs: Transportation of raw materials, equipment, and finished products to and from the islands. Import tariffs, customs fees, and potential delays contribute to overall costs.
- Research and Development (R&D): Initial investment in process development, optimization, and pilot studies. This is particularly relevant for novel bioproducts.
- Consumables: Cost of disposable items like filters, tubing, and sterile packaging.
Affordable Upstream Bioprocessing Options
Affordable upstream bioprocessing focuses on the initial stages of biopharmaceutical manufacturing, involving cell culture, fermentation, or microbial growth. The goal is to maximize yield and quality while minimizing costs. Value bundles are strategic groupings of complementary products and services offered at a combined price, aiming to provide greater overall benefit and cost-effectiveness than purchasing items individually. Cost-saving strategies in upstream bioprocessing involve optimizing resource utilization, reducing waste, and leveraging innovative technologies. This approach is crucial for making biopharmaceutical production more accessible and competitive.
| Value Bundle Example | Components | Key Benefit | Cost-Saving Aspect |
|---|---|---|---|
| Integrated Media & Optimization Service | Customized cell culture media formulation, media screening services, and process optimization consultation. | Maximized cell growth and product titer for a specific cell line and product. | Reduced media costs through optimization, fewer experimental runs for media development, faster time to clinic/market. |
| Single-Use Bioreactor Starter Pack | Disposable bioreactor bag, associated tubing, sensors, and a basic control system. | Rapid setup and reduced validation burden for early-stage development or clinical trials. | Lower upfront capital investment compared to stainless steel, eliminates cleaning validation costs, faster project initiation. |
| Automation & Data Management Suite | Automated sampling system, real-time process monitoring software, and cloud-based data analytics platform. | Improved process control, reduced manual intervention, and enhanced data integrity. | Reduced labor costs, fewer operator errors, faster root cause analysis for deviations, improved process understanding leading to optimization. |
| Raw Material Bulk Purchase & Logistics | Discounted pricing for bulk procurement of essential raw materials (e.g., sugars, amino acids) coupled with just-in-time delivery. | Ensured supply chain reliability and reduced inventory holding costs. | Lower per-unit cost of raw materials, reduced waste due to expiry, optimized warehouse space. |
| Process Intensification Technology Package | High-efficiency perfusion system components, advanced aeration technologies, and process modeling software. | Increased volumetric productivity and reduced footprint. | Higher output from smaller equipment, potentially lower facility costs, reduced capital expenditure per unit of product. |
Key Cost-Saving Strategies in Upstream Bioprocessing
- Media Optimization: Developing cost-effective and high-performing cell culture media or fermentation broths to maximize cell growth and product yield. This can involve using cheaper raw materials, reducing the concentration of expensive components, or tailoring media to specific cell lines and processes.
- Process Intensification: Implementing technologies and strategies that increase the production rate and efficiency within a given bioreactor volume. Examples include continuous processing, perfusion cell culture, and high-density fermentation.
- Single-Use Technologies (SUTs): While initial costs can be higher, SUTs can reduce capital expenditure, eliminate cleaning and sterilization validation, and minimize cross-contamination risks, leading to overall cost savings, especially for smaller-scale or multi-product facilities.
- Automation and Digitalization: Implementing automated systems for monitoring, control, and data logging reduces labor costs, improves process consistency, and enables better troubleshooting. Digital tools can also facilitate predictive maintenance and process optimization.
- Raw Material Sourcing and Negotiation: Establishing strong relationships with suppliers, bulk purchasing, and negotiating favorable pricing for critical raw materials like amino acids, sugars, and growth factors.
- Waste Reduction and Recycling: Minimizing waste generation through process optimization and exploring opportunities for recycling or reusing components where scientifically and regulatory sound.
- Scale-Up Strategy: Careful and efficient scale-up of processes from lab to pilot to commercial scale is essential to avoid costly errors and delays.
- Outsourcing Non-Core Activities: Considering outsourcing certain non-critical or specialized activities (e.g., media preparation, equipment maintenance) to specialized service providers to leverage their expertise and potentially reduce internal overheads.
- Energy Efficiency: Implementing energy-saving measures in incubation, agitation, and downstream processing can contribute to significant operational cost reductions.
- Robust Process Development: Thorough and well-designed process development reduces the need for costly reworks or unexpected issues during manufacturing.
Verified Providers In Cabo Verde
When seeking healthcare services in Cabo Verde, particularly for specialized or international-standard care, ensuring the credibility and qualifications of providers is paramount. Franance Health stands out as a leading entity in this regard, offering a rigorously vetted network of healthcare professionals and facilities. Their commitment to verifying credentials ensures that patients have access to safe, effective, and ethical medical treatment. This meticulous vetting process minimizes risks associated with unqualified practitioners and guarantees a higher standard of care, making Franance Health the premier choice for accessing verified healthcare services in Cabo Verde.
| Credential Type | Verification Process | Impact on Patient Care |
|---|---|---|
| Medical Licenses & Certifications | Franance Health meticulously verifies all national and international medical licenses and certifications with relevant governing bodies. | Confirms practitioners possess the required legal authority and specialized training to practice medicine safely and competently. |
| Educational Background | Scrutiny of medical degrees, diplomas, and postgraduate qualifications from accredited institutions. | Validates the foundational knowledge and academic rigor of healthcare providers. |
| Professional Experience & Specializations | Thorough review of work history, practice areas, and documented surgical/procedural experience. | Ensures providers have practical, hands-on experience in their declared fields and relevant specializations. |
| Reputation & Ethical Conduct | Includes background checks and, where applicable, consultation with professional associations and previous employers. | Assesses the provider's commitment to ethical medical practice and patient well-being, minimizing the risk of malpractice or misconduct. |
| Facility Accreditation | For partner clinics and hospitals, Franance Health verifies compliance with international healthcare standards and local regulations. | Guarantees that the healthcare environment is safe, hygienic, and equipped to provide quality medical services. |
Why Franance Health Credentials Matter:
- Ensures patient safety and quality of care.
- Guarantees access to licensed and certified medical professionals.
- Provides peace of mind for international and local patients.
- Mitigates risks associated with unqualified or fraudulent providers.
- Facilitates access to specialized medical expertise.
Scope Of Work For Upstream Bioprocessing
This document outlines the Scope of Work (SOW) for Upstream Bioprocessing, focusing on the technical deliverables and standard specifications required for successful cell culture and fermentation processes. The objective is to define the critical parameters, quality attributes, and testing requirements for the upstream development and manufacturing stages. This SOW is applicable to activities such as cell line development, media optimization, process development, scale-up, and routine manufacturing of biological products.
| Deliverable | Description | Standard Specifications/Acceptance Criteria | Associated Testing Methods |
|---|---|---|---|
| Master Cell Bank (MCB) / Working Cell Bank (WCB) | Cryopreserved viable cells maintained under GMP conditions. | Cell viability ≥ 90% post-thaw. Genetic stability confirmed. Sterility negative. No adventitious agents detected. | Viability assay (e.g., Trypan Blue exclusion), Isoenzyme analysis, Sterility testing (USP <71>), Mycoplasma testing (USP <63>), Viral testing (USP <1214>). |
| Optimized Cell Culture Media | Chemically defined or hydrolysate-based media formulations supporting optimal cell growth and productivity. | Sterile filtered. Batch-to-batch consistency (±10% for key components). Performance qualification demonstrating equivalent or superior cell growth and titer compared to reference. | Sterility testing, Component analysis (e.g., HPLC, ICP-MS), Performance qualification (small-scale bioreactor runs). |
| Inoculum Expansion Protocol | Defined procedure for expanding cells from WCB to inoculation volume for production bioreactors. | Reproducible cell growth rates. Titer within ±15% of target at each stage. Cell viability ≥ 90%. | Cell counting and viability assays, Growth curve analysis. |
| Bioreactor Process Definition | Detailed operating parameters for the production bioreactor, including temperature, pH, dissolved oxygen, agitation, aeration, nutrient feeding strategies, and harvest criteria. | Process parameters maintained within defined control ranges (e.g., Temp: ±0.5°C, pH: ±0.1). Product titer within ±15% of target. Process robustness demonstrated through Design of Experiments (DoE). | In-situ sensor monitoring, Off-line sampling and analysis (cell density, viability, metabolites, product titer), DoE reports. |
| Process Transfer Package | Comprehensive documentation for seamless technology transfer to manufacturing sites. | Includes executed batch records, development reports, critical process parameters (CPPs), critical quality attributes (CQAs), and analytical method validation reports. | Review of documentation against pre-defined transfer criteria. |
| Process Validation Report | Documented evidence that the upstream process consistently produces a product meeting predetermined specifications and quality attributes. | Successful completion of at least three consecutive validation batches meeting all acceptance criteria. | Batch records review, CQAs analysis of validation batches, Statistical analysis of results. |
| Routine Manufacturing Batch Records | Executed records for commercial production batches. | All process parameters within defined ranges. Product quality attributes meet release specifications. Deviation investigations thoroughly documented. | In-process controls (IPC) monitoring, Final product release testing. |
| Upstream Raw Material Specifications | Defined quality attributes for all raw materials used in upstream bioprocessing (e.g., cell culture media components, buffers, excipients). | Purity, identity, potency, microbial limits, endotoxin levels, and other relevant parameters as per pharmacopoeial standards or established internal limits. | Supplier Certificates of Analysis (CoAs), Incoming material testing (as per USP/EP monographs or validated methods). |
Key Upstream Bioprocessing Stages and Activities
- Cell Line Development and Characterization
- Media Preparation and Optimization
- Inoculum Train Development
- Bioreactor Process Development and Optimization
- Process Scale-up and Technology Transfer
- Process Validation
- Routine Upstream Manufacturing
- Quality Control and Release Testing
Service Level Agreement For Upstream Bioprocessing
This Service Level Agreement (SLA) outlines the guaranteed response times and uptime for upstream bioprocessing services provided by [Your Company Name] to [Client Company Name]. This agreement is effective as of [Start Date] and will remain in effect until [End Date], unless terminated earlier in accordance with the Master Services Agreement (MSA).
| Service Component | Guaranteed Uptime | Critical Incident Response Time | Non-Critical Incident Response Time |
|---|---|---|---|
| Bioreactor Operation & Monitoring | 99.5% Uptime (excluding scheduled maintenance) | 15 minutes | 2 hours |
| Cell Culture Media Preparation | 99.0% Uptime (scheduled batch production) | 30 minutes | 4 hours |
| Seed Train Expansion | 99.5% Uptime (during scheduled runs) | 1 hour | 8 hours |
| Process Sampling & IPC | N/A (Service availability based on client schedule) | 30 minutes (for immediate sample processing needs) | 2 hours (for routine sample processing) |
| Data Logging & Reporting | 99.9% Uptime | 1 hour | 4 hours |
Scope of Services Covered
- Cell culture media preparation and supply.
- Seed train expansion and inoculum development.
- Bioreactor operation and monitoring (including but not limited to temperature, pH, dissolved oxygen, agitation, and gas flow control).
- Process sampling and in-process control (IPC) testing.
- Harvest operations.
- Data logging and reporting for all upstream activities.
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