Bioprocessing Solutions for Modern Biomanufacturing
Transform your biopharmaceutical manufacturing with flexible, sterile single-use systems. Reduce costs, accelerate timelines, and ensure consistent quality.
The Future of Biopharmaceutical Manufacturing
Single-use bioprocessing technology has revolutionized biopharmaceutical manufacturing by offering flexible, sterile, and cost-effective alternatives to traditional stainless steel systems. At SeamlessBio, we provide a comprehensive portfolio of single-use bioprocessing solutions designed to meet the evolving needs of modern biomanufacturing – from R&D scale to commercial production.
Our 2D bioprocess bags, 3D bioreactor bags, and tank liners eliminate the need for cleaning validation, reduce cross-contamination risk, and accelerate production timelines. All products are manufactured in our ISO 13485-certified facility in Germany, ensuring consistent quality and full regulatory compliance for cGMP environments.
Why Single-Use Bioprocessing?
Traditional stainless steel systems have served biomanufacturing for decades, but single-use technology offers compelling advantages for modern production environments.
Traditional Stainless Steel
Single-Use Systems
Our Comprehensive Bioprocessing Portfolio
SeamlessBio offers a complete range of single-use bioprocessing systems designed to support every stage of biopharmaceutical manufacturing – from initial media preparation to final product storage.
2D Bioprocess Bags
Flexible pillow-style bags ideal for media preparation, buffer mixing, and storage applications. Excellent mixing efficiency and easy handling make these the workhorse of bioprocessing.
Volume Range: 150 mL to 50 liters
Best For: Media prep, mixing, storage, transport
Key Advantage: Superior mixing on orbital shakers
3D Bioprocess Bags
Three-dimensional bags engineered for optimal oxygen transfer in bioreactor applications. Compatible with rocking and orbital platforms for cell culture and fermentation.
Volume Range: 1 liter to 200+ liters
Best For: Cell culture, fermentation, mAb production
Key Advantage: Optimized O₂ transfer for cell growth
Tank Liners
Single-use liners for stainless steel tanks and portable containers. Perfect for large-scale storage, bulk transport, and commercial manufacturing operations.
Volume Range: 50 liters to 5,000+ liters
Best For: Bulk storage, transport, manufacturing
Key Advantage: Eliminate tank cleaning and validation
Applications Across Biomanufacturing
Our bioprocessing solutions support a diverse range of applications in biopharmaceutical manufacturing, from early research to commercial production:
Monoclonal Antibody Production
Cultivate mammalian cells in 3D bioreactor bags for mAb manufacturing. Prepare media and buffers in 2D bags. Store bulk product in tank liners.
Vaccine Manufacturing
Produce viral vaccines, VLPs, and antigens using single-use bioreactor systems. Reduce contamination risk and accelerate batch turnaround.
Gene & Cell Therapy
Manufacture AAV vectors, CAR-T cells, and other advanced therapies. Maintain sterility and quality throughout production.
Microbial Fermentation
Cultivate bacteria and yeast for enzyme production, metabolite manufacturing, and biosynthetic processes.
Media & Buffer Preparation
Mix powdered media, prepare culture buffers, and add supplements using 2D bags with orbital shakers or rocking platforms.
R&D & Process Development
Develop and optimize processes at small scale before transferring to production. Flexible volumes support iterative development.
Intermediate Storage & Hold
Store process intermediates, harvested cells, and bulk products at various temperatures using validated single-use containers.
Transport & Distribution
Safely transport materials between facilities, to contract manufacturers, or to final fill/finish operations.
Key Benefits of Our Bioprocessing Solutions
Reduced Capital Investment
Single-use systems require 50-85% less capital than equivalent stainless steel infrastructure. Lower upfront costs enable faster facility deployment and reduced financial risk.
Faster Time to Market
Eliminate weeks of cleaning validation and months of equipment installation. Deploy new processes in days instead of months, accelerating your path to clinical trials and commercialization.
Enhanced Product Safety
Pre-sterilized, single-use containers minimize cross-contamination risk. Each batch uses a new, sterile system – no cleaning residues or carry-over concerns.
Reduced Environmental Impact
Eliminate water consumption for cleaning (1,000s of liters per batch). Reduce chemical waste, steam usage, and overall facility footprint.
Ultimate Flexibility
Easily switch between products, cell lines, or processes without extensive changeover. Support multiple projects in the same facility simultaneously.
Simplified Operations
Reduce complexity of facility operations, maintenance, and qualification. Fewer systems to clean, calibrate, and validate means leaner operations teams.
Regulatory Compliance
ISO 13485-certified manufacturing, cGMP compliance, and complete documentation packages support FDA, EMA, and global regulatory submissions.
Scalable Solutions
Seamless scale-up from R&D (mL) to pilot (L) to commercial (100s-1000s L) using the same technology platform. De-risk scale-up transitions.
Your Journey to Single-Use Bioprocessing
Transitioning to single-use technology is straightforward with our comprehensive support. Here's what the typical implementation journey looks like:
Consultation & Assessment
Our bioprocessing specialists review your current processes, identify opportunities for single-use integration, and recommend optimal solutions for your applications.
Timeline: 1-2 weeks
Solution Design & Customization
Configure bag volumes, port types, tubing specifications, and other parameters to match your exact process requirements. Receive technical documentation and validation support.
Timeline: 2-4 weeks
Product Manufacturing & Delivery
Your custom-configured bags are manufactured in our ISO 13485-certified facility, gamma sterilized, and shipped with complete certificates and documentation.
Timeline: 4-8 weeks (standard) | 6-12 weeks (custom)
Process Integration & Validation
Integrate single-use bags into your process workflow. We provide technical support, validation protocols, and troubleshooting assistance during implementation.
Timeline: 2-6 weeks
Production & Ongoing Support
Begin full-scale production with single-use systems. Access ongoing technical support, reordering assistance, and process optimization consultation.
Timeline: Continuous
Quality You Can Trust
All SeamlessBio bioprocessing products are manufactured under strict quality control in our ISO 13485:2016 certified facility in Germany. Our commitment to quality ensures you receive products that meet the highest standards for biopharmaceutical manufacturing.
ISO 13485:2016 Certified
Medical device quality management system certification ensures consistent manufacturing processes and comprehensive quality control.
cGMP Compliance
Current Good Manufacturing Practice compliant production suitable for pharmaceutical and biopharmaceutical applications.
USP Class VI Materials
All materials meet USP <88> Class VI biocompatibility requirements. Extractables and leachables data available upon request.
Validated Sterilization
Gamma sterilization per ISO 11137 to SAL 10⁻⁶. Complete dose mapping and validation documentation provided.
Made in Germany
Manufactured in our German facility ensuring European quality standards, precision engineering, and regulatory compliance.
Complete Documentation
Certificates of Conformance, sterilization certificates, material certifications, and regulatory support files for submissions.
Ready to Transform Your Bioprocessing?
Our bioprocessing specialists are ready to help you select the optimal single-use solutions for your applications and provide expert technical support throughout your journey.
Expert Support Available: Technical consultation | Custom configurations | Fast quotes | Validation assistance | Ongoing support
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