Core-Shell Technology for Virus Purification
Хроматографическая смола InertShell Core-Shell
Для очистки аденовирусов ADV
Хроматографическая смола Biovanix InertShell is a revolutionary core-shell technology-based resin designed for the purification of viruses and large biomolecules. Combining size-exclusion separation with binding chromatography, this advanced resin efficiently captures and isolates large biomolecules while allowing smaller contaminants to pass through and bind within the core.
This dual functionality ensures high-purity outcomes in downstream processing.
20 mg/mL
BSA Binding Capacity
≤1,0 МПа
Максимальное давление
pH 3–13
Wide pH Stability
30+
Reuse Cycles
How It Works
Dual-Function Core-Shell Architecture
Combining size-exclusion and binding chromatography in a single resin for unmatched purification efficiency.
Size-Exclusion + Binding in One Step
The outer shell is hydrophilic and neutral with 50-100 nm pores. Large biomolecules (e.g., inactivated viruses) are too large to penetrate the shell and are collected directly in the flow-through fraction (FT mode).
Smaller contaminants (<700 kDa) diffuse through the shell into the macroporous core (200-500 nm), where octylamine ligands provide both anion exchange and hydrophobic interaction to capture and retain impurities.
Key advantage: The thinner shell layer (0.5-1.0 μm vs. competitor’s 5 μm) enables faster mass transfer of impurities to the core for capture, resulting in higher yield of impurity removal and more efficient CIP cleaning.
Product Features
Designed for Demanding Biopurification
Four key capabilities that set InertShell apart in virus and biomolecule downstream processing.
🔬 Core-Shell Technology
- Двойная функциональность: Одновременно выполняет разделение методом эксклюзионной хроматографии и аффинной хроматографии.
- Эффективное разделение Крупные биомолекулы (например, инактивированные вирусы) собираются во фракции, проходящей через колонку (режим FT), в то время как загрязнители (<700 кДа) связываются с внутренними лигандами.
- Оптимизированная конструкция Внешняя оболочка гидрофильна и нейтральна, предотвращая нежелательные взаимодействия и обеспечивая высокие скорости потока.
⚗️ Advanced Material Composition
- Полимерная база: Изготовлен из полимерных микросфер метакрилата для высокой прочности и химической стойкости.
- Активный лиганд: Октиламиновый лиганд в ядре обеспечивает как анионообменные, так и гидрофобные возможности взаимодействия.
- Пористая структура Оболочка имеет размер пор 50-100 нм, в то время как ядро
приблизительно от 200 до 500 нм, что обеспечивает эффективное разделение по размеру молекул.
✨ High Purity and Efficiency
- Выборочный захват: Эффективно удаляет примеси, такие как белки хозяйских клеток, фрагменты ДНК, эндотоксины и альбумин.
- Высокая производительность: Разработаны для обработки крупномасштабных процессов очистки с высокой эффективностью и масштабируемостью.
🛡️ Compliance and Safety
- Неживотного происхождения Manufactured using synthetic processes, ensuring compliance with regulatory standards and ethical requirements.
- Стабильная производительность: Надежно при различных масштабах производства, обеспечивая стабильные результаты.
Technical Specifications
Complete Product Specifications
Detailed technical data for method development, validation, and process integration.
| Характеристика | Описание |
|---|---|
| Матрица поддержки | Сшитый поли(стирол-девинилбензол) |
| Средний размер частиц | 50-150 мкм |
| Средний размер пор | 200 nm (core); 50-100 nm (shell) |
| Функциональность поверхности | поли(dT) 25мер с запатентованным линкером |
| Плотность лиганда | 0,10-0,20 ммоль/мл |
| Устойчивость к механическим воздействиям | 70 бар (1 000 фунтов на квадратный дюйм; 7 МПа) |
| Термическая стабильность | Allows sample denaturing at 65°C if needed |
| Диапазон pH | 2-13 |
| Диапазон ионной силы | От 0 до 5 М, все распространенные соли |
| Химическая стойкость | Common agents for mRNA purification, include 0.5 M NaOH, 2 M MgCl₂, 20 mM EDTA. Water, 0 to 100% alcohol, acetonitrile, 2 M acetic acid, 1 M HCl, and other common organic solvents |
| Хранение | 18-20% этанол |
Competitive Edge
Biovanix InertShell vs. Competitor 700
Direct performance comparison demonstrates clear advantages across key parameters.
| Биованикс Инерт Шел | Конкурент 700 | |
| Матрица | Полиакрилат | Высоко сшитый агароз |
| Лиганд | Октиламин | Октиламин |
| Средний размер частиц | 50-150 мкм | 50-150 мкм |
| Плотность лиганда | 0,10-0,20 ммоль/мл | 0,04-0,085 ммоль/мл |
| Связывающая способность¹ | 20 мг БСА/мл смолы | 12 мг БСА/мл смолы |
| Рабочее давление | ≤1,0 МПа | ≤0,3 МПа |
| Рабочий расход | 100-600 см/ч | 100-600 см/ч |
| pH устойчивость | 3-13 | 3-13 |
| Температура | 4-30℃ | 4-30℃ |
| Химическая устойчивость | Все широко используемые водные буферные растворы: 1 М раствор гидроксида натрия (NaOH)², 6 М раствор гидрохлорида гуанидина, 30% изопропанол и 70% этанол. | |
| Хранение | 20% в этаноле при температуре от 4 °C до 25 °C | |
- Динамическая связывающая способность измерялась при прорыве 5% со скоростью 76 см/ч на колонках размером φ10×13 мм и объемом 1 мл. В качестве буфера использовался раствор 1,0 мг/мл BSA в 50 мМ NaCl, pH 0.
- Существенных изменений ионной емкости и содержания углерода после хранения 1 неделю в 1 М NaOH при 25°C не наблюдается.
2.5×
1.67×
3.3×
Thinner Shell, Faster Mass Transfer
Compared with Competitor 700, the thickness of the core in Biovanix InertShell (0.5-1.0 μm) is significantly smaller than Competitor 700 (5 μm). This thinner shell is conducive to the rapid mass transfer of impure proteins to the medium core for capture, including host cell proteins, DNA fragments, endotoxin, and serum. Biovanix InertShell delivers a higher yield of impurity removal. With the macroporous structure (200-500 nm) of the core, InertShell can quickly remove captured impurities during CIP, and demonstrates a longer service life — in animal vaccine studies, consistent performance for more than 30 reuse cycles.
Преимущества с первого взгляда
Why Biovanix InertShell Resin
Purpose-built for high-purity virus and biomolecule downstream processing.
⚡
Высокая эффективность
Быстрая и эффективная очистка мРНК.
📈
Масштабируемый процесс
Легко адаптируется к крупномасштабному производству.
🛡️
Соответствие нормативным требованиям
Не содержит животных и синтетических веществ.
💰
Экономически эффективный
Упрощенный рабочий процесс снижает операционную сложность и затраты.
🔄
Long Service Life
30+ reuse cycles with consistent performance.
Приложения
Built for the Future of Biopharmaceuticals
From vaccine production to gene therapy, InertShell supports your most critical purification workflows.
Очистка вирусов
Эффективная изоляция инактивированных вирусов для вакцин и генной терапии.
Разделение больших биомолекул
Подходит для очистки крупных белков и комплексов.
Удаление белков клетки-хозяина
Эффективное удаление белков хозяйской клетки и других примесей.
Производство вакцин
Оптимизированная последующая переработка мРНК-вакцин и вакцин на основе вирусных векторов.
Генная терапия
Масштабируемое производство вирусных векторов для генной терапии.
Why Choose Biovanix
Your Trusted Partner in Chromatography
① Enhanced Purity
Эффективное удаление примесей для достижения сверхвысокой чистоты при очистке вирусов и биомолекул.
② Dual Mode Operation
Объединяет эксклюзионную хроматографию и хроматографию на основе связывания для универсального и точного контроля.
③ Scalable Solution
Идеально подходит как для лабораторных, так и для крупномасштабных производственных процессов.
④ Cost-Effective
Упрощенные технологические процессы и высокая эффективность снижают эксплуатационные расходы и повышают производительность.
⑤ Regulatory Compliance
Неживотное и синтетическое производство обеспечивают соответствие мировым биофармацевтическим стандартам.
Frequently Asked Questions
InertShell Resin FAQ
Common questions about core-shell chromatography for virus and biomolecule purification.
What is InertShell Core-Shell Chromatography Resin and how does it work?
Biovanix InertShell is a core-shell chromatography resin designed for the purification of viruses and large biomolecules. It combines size-exclusion separation with binding chromatography in a single step. The outer shell is hydrophilic and neutral with 50-100 nm pores, while the inner core features macropores of 200-500 nm functionalized with octylamine ligands. Large biomolecules like inactivated viruses pass through in the flow-through fraction, while smaller contaminants (<700 kDa) including host cell proteins, DNA fragments, and endotoxins bind to the internal ligands.
What is the difference between core-shell and fully porous chromatography resins?
Core-shell resins feature a non-porous solid core surrounded by a thin porous outer shell. This architecture reduces mass transfer resistance compared to fully porous particles, enabling faster flow rates with lower backpressure. The reduced diffusion path means analytes spend less time diffusing in and out of pores, resulting in sharper peaks, higher resolution, and shorter processing times. Biovanix InertShell further enhances this by using a polymeric methacrylate base rather than silica, providing superior chemical stability across pH 3-13.
What applications is InertShell resin best suited for?
InertShell resin is optimized for five key applications: (1) Virus purification — efficient isolation of inactivated viruses for vaccines and gene therapies; (2) Large biomolecule separation — purification of large proteins and complexes; (3) Host cell protein (HCP) removal — efficient elimination of HCPs and other process impurities; (4) Vaccine production — streamlined downstream processing for mRNA vaccines and viral vector-based vaccines; (5) Gene therapy — scalable production of viral vectors. It is particularly suited for adenovirus (ADV) purification.
How does InertShell compare to competing core-shell resins?
Compared to Competitor 700 (agarose-based), Biovanix InertShell offers several advantages: (1) 1.67× higher binding capacity (20 mg BSA/mL vs. 12 mg BSA/mL); (2) 3.3× higher operational pressure tolerance (1.0 MPa vs. 0.3 MPa); (3) 2.5× higher ligand density (0.10-0.20 mmol/mL vs. 0.04-0.085 mmol/mL); (4) Thinner shell layer (0.5-1.0 μm vs. 5 μm) enabling faster mass transfer of impurities to the core for capture; (5) Polymeric methacrylate base provides greater chemical stability than agarose; (6) Demonstrated reusable performance of 30+ cycles with minimal property changes in animal vaccine applications.
What is the recommended flow rate for InertShell resin?
Biovanix InertShell supports operational flow rates of 100-600 cm/h at pressures up to 1.0 MPa (approximately 10 bar). The rigid polymeric methacrylate matrix maintains structural integrity even at elevated flow rates. Users should adjust flow rate depending on the specific application and performance requirements, while ensuring the upper pressure limitation is not exceeded. The core-shell architecture ensures efficient mass transfer even at high linear velocities.
Can InertShell resin be reused, and how do I clean it?
Yes, InertShell resin is designed for multiple reuse cycles. The resin demonstrates excellent chemical stability and can withstand cleaning with 1 M NaOH (no significant changes in ionic capacity and carbon content after 1 week storage in 1 M NaOH at 25°C), 6 M guanidine hydrochloride, 30% isopropanol, and 70% ethanol. The macroporous core structure (200-500 nm) enables rapid removal of captured impurities during CIP. In animal vaccine purification studies, the resin has been demonstrated to maintain consistent performance over 30+ reuse cycles.
What buffer and storage conditions are required?
InertShell resin is compatible with all commonly used aqueous buffers, 1 M NaOH, 6 M guanidine hydrochloride, 30% isopropanol, and 70% ethanol. It operates across a pH range of 3-13 and ionic strength range of 0 to 5 M. Operating temperature range is 4-30°C. For storage, keep the resin in 20% ethanol at 4°C to 25°C. Do not expose to strong oxidizers (hypochlorite), oxidizing acids (nitric acid), strong reducing agents (sulfite), acetone, THF, or benzyl alcohol.
How does InertShell achieve dual functionality in size-exclusion and binding chromatography?
InertShell achieves dual functionality through its unique core-shell architecture. The outer shell is hydrophilic and neutral with small pores (50-100 nm), which prevents large biomolecules like viruses from entering and interacting with the surface. These large molecules are collected in the flow-through fraction (FT mode). Meanwhile, the inner core has large macropores (200-500 nm) functionalized with octylamine ligands that provide both anion exchange and hydrophobic interaction capabilities, capturing smaller contaminants (<700 kDa) including host cell proteins, DNA fragments, endotoxins, and albumin.
Is InertShell resin suitable for GMP manufacturing?
Yes, InertShell resin is manufactured using synthetic processes and is non-animal derived, ensuring compliance with regulatory standards and ethical requirements. This makes it suitable for use in GMP manufacturing environments for vaccine production and gene therapy applications. The consistent performance across various production scales and the demonstrated reusability (30+ cycles) support cost-effective and compliant large-scale biopharmaceutical manufacturing.
What particle size does InertShell use and why does it matter?
InertShell resin uses particles with an average size of 50-150 μm. The core-shell design within each particle is key: the thin outer shell (0.5-1.0 μm thickness) with small pores creates the size-exclusion effect for large biomolecules, while the macroporous core provides high-capacity binding for smaller impurities. This dual-size architecture within each particle enables the simultaneous size-based separation and affinity-based capture that distinguishes InertShell from conventional single-mechanism resins.
How does InertShell compare to agarose-based resins for virus purification?
InertShell’s polymeric methacrylate base offers significant advantages over traditional agarose-based resins: (1) Higher mechanical strength — supports pressures up to 1.0 MPa vs. 0.3 MPa for agarose, enabling faster processing; (2) Wider chemical compatibility — stable with NaOH, guanidine hydrochloride, organic solvents; (3) Higher binding capacity — 20 mg BSA/mL vs. 12 mg BSA/mL; (4) Higher ligand density — 0.10-0.20 mmol/mL vs. 0.04-0.085 mmol/mL; (5) Longer service life — demonstrated 30+ reuse cycles with consistent performance; (6) Faster mass transfer — thinner shell layer (0.5-1.0 μm vs. 5 μm) allows quicker impurity capture and CIP cleaning.
What impurities can InertShell resin remove from my sample?
InertShell resin effectively removes a broad range of process-related impurities while retaining your target large biomolecules in the flow-through: (1) Host cell proteins (HCPs); (2) DNA fragments; (3) Endotoxins; (4) Albumin; (5) Other contaminants smaller than 700 kDa. The octylamine ligand in the core provides both anion exchange and hydrophobic interaction mechanisms, enabling multi-modal impurity capture. This comprehensive impurity removal in a single step significantly simplifies downstream processing workflows.
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Ready to Transform Your Virus Purification Workflow?
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