For over 25 years, Biotech Verde has been a trusted provider of validation services to the biopharmaceutical industry. With a profound understanding of the regulatory landscape, we adopt a consultative approach to address your validation-related challenges, ensuring compliance even after completing your project.
Key Benefits
• Validation Studies in as Fast as 6 Weeks
• Swift turnaround time for your validation needs.
• Unique Expertise in E&L (Extractables&Leachables)
• There are no unknowns and no open questions for Biotech Verde products.
• Cost Efficiency Through a Risk-Based Approach
• Ensuring value through a tailored, risk-based methodology.
Our Offering for Your Regulatory Safety – Confidence®
Whether implementing single-use systems (SUS) or conventional equipment, Confidence® provides a comprehensive range of validation services. Our services cover various tests for all process components, including but not limited to bags, container closure systems, mixing systems, sterile filters, transfer systems, membrane adsorbers, virus filters, and more.
Validation Services for Various Processes
• Buffer | Media Preparation
• Fermentation
• Purification
• Concentration | Buffer Exchange
• Sterile Filtration
• Storage
• Final Filling
• Validation Services for Various Processes:
• Ensure the integrity and compliance of your processes with our expert validation services, tailored to meet the unique requirements of your industry.
Buffer | Media Preparation:
• Precision in every mix – trust our buffer and media preparation services for meticulous formulation and preparation, which is essential for successful processes.
Fermentation:
• Cultivate success with our fermentation services, optimizing conditions for microbial growth and ensuring optimal yields in your bioprocesses.
Purification:
• Elevate purity standards with our purification services, designed to refine and purify biopharmaceutical compounds to meet the highest quality benchmarks.
Concentration | Buffer Exchange:
• Streamline your processes with our concentration and buffer exchange services, enhancing efficiency and ensuring the proper concentrations for your valuable products.
Sterile Filtration:
• Uphold sterility with confidence – our sterile filtration services safeguard your processes by removing contaminants, ensuring the integrity of your final product.
Storage:
• Trust our secure storage solutions to preserve the potency and stability of your valuable products, providing a reliable repository for critical stages in your workflow.
Final Filling:
• Seal the deal with precision – our final filling services ensure accurate and aseptic packaging, delivering your products to market with the utmost quality and integrity.
Virus Clearance Services
Confidence® Virus Clearance Services ensures thorough virus clearance steps with short turn-around times, as fast as six weeks. Our services include feasibility studies, process design/optimization, experiments (DoE) design, and GLP Virus Clearance Studies.
• Feasibility studies
• Process design/process optimization and design of experiments (DoE)
• GLP Virus Clearance Studies
Feasibility Studies:
a. Explore the potential and viability of your project with our comprehensive feasibility studies, providing insights and assessments crucial for informed decision-making.
Process Design/Process Optimization and Design of Experiments (DoE):
. Elevate your processes with our expert guidance in process design and optimization, utilizing Design of Experiments (DoE) methodologies to enhance efficiency and performance.
GLP Virus Clearance Studies:
. Ensure regulatory compliance and product safety through our Good Laboratory Practice (GLP) virus clearance studies, offering thorough assessments to validate the effectiveness of viral clearance in your processes.
Extractables & Leachable Testing
Drawing on our unique expertise in E&L, we precisely understand the compounds present in Biotech Verde products. Our services encompass Extractables Assessment, Extractables Study, E&L Storage Study, Leachables Testing, and Safety Evaluation.
• Extractables Assessment
• Extractables Study
• E&L Storage Study
• Leachables Testing
• Safety Evaluation
Extractables Assessment:
a. Evaluate the potential extractables in your materials with our comprehensive assessment, ensuring a thorough understanding of substances that may migrate into your products.
Extractables Study:
. Dive deep into material interactions with our extractable study, providing valuable insights into the substances that can be released under various conditions and aiding in product safety evaluations.
E&L Storage Study:
. Explore the effects of storage on Extractables and Leachables (E&L) with our specialized study, assessing how these components may evolve and impact the safety and quality of your products.
Leachable Testing:
. Ensure product safety by identifying and quantifying leachables with our rigorous testing, addressing potential risks associated with substances migrating from packaging or processing materials.
Safety Evaluation:
. Prioritize safety in your products with our comprehensive safety evaluation services, encompassing a holistic assessment of materials, processes, and potential risks to meet regulatory standards and ensure consumer well-being.
Sterile Filtration and Single-Use System Validations
Our validation experts assist in identifying validation needs and appropriate testing scopes for all filters and SUS. Services include microbiological studies, physicochemical studies, and shipping/storage validation.
• Microbiological studies
• Physico-chemical studies
• Shipping and storage validation
Microbiological Studies:
a. Safeguard the integrity of your products with our microbiological studies, ensuring compliance with quality standards and addressing microbial challenges in your processes.
Physico-Chemical Studies:
. Dive into the intricacies of material behavior with our physicochemical studies, offering in-depth insights into the physical and chemical properties crucial for product quality and performance.
Shipping and Storage Validation:
. Validate the robustness of your shipping and storage procedures with our specialized services, ensuring that products maintain their integrity and efficacy throughout the logistics chain, meeting quality and regulatory requirements.
Particle Validation Standards
We offer certified and customized sets for visual inspection training programs to ensure that final drug products are “essentially free” or “practically free” of particles. That includes loose particles and defect test kits.
• Loose particles
• Defect test kits
Loose Particles:
a. Mitigate risks and ensure product quality with our meticulous assessment of loose particles, addressing potential contaminants that could compromise the integrity of your materials or products.
Defect Test Kits:
. Enhance quality control with our defect test kits, providing efficient tools to identify and address defects in materials or products, ensuring that only high-quality items reach the market.
Conclusion
Biotech Verde’ Confidence® Validation Services is a reliable partner, ensuring compliance and operational excellence. With a commitment to fast timelines, unique expertise, and cost-effective solutions, we confidently safeguard your regulatory safety.
