Why IEX resins are used in processing of more than 70% bio-pharmaceuticals?

In the downstream processing of bio-pharmaceuticals, ion exchange chromatography(IEX) enjoys advantages such as high resolution, large processing volume, easy operation and wide application, making it an indispensable part in the purification of macromolecules including antibody, vaccine and recombinant proteins.

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Principle

IEX is a type of technology which achieves separation based on the electrostatic interaction of charges on the surface of molecules and resin beads. The target molecules are negatively or positively charged under certain pH condition, enabling its bind to cation or anion exchange chromatography resins. By adjusting pH and conductance in buffer system, efficient separation between target molecules and impurities can be achieved.

Protein titration curve

Protein titration curve is a key method for the understanding of IEX processing design by helping determine the suitable bind/elute condition.

• Each type of protein enjoys a unique net charge/pH relation, which can be presented by titration curve.

 • Net charge on the surface of protein can change as pH varies. The right pH can make strength and property of net charge on the target protein surface different from those of other molecules, therefore achieving separation purpose by providing different binding strength between target molecules and resin compared with other molecules.

Note: when pH of solution is lower than the pI of molecule, molecule is positively charged（+） on the surface. when pH of solution is higher than the pI of molecule, molecule is negatively charged（-） on the surface.

Fig.1 Protein titration curve

Experiment process

 • Equilibration: equilibrate with equilibration buffer until pH and conductance of column outlet buffer reach the same as equilibration buffer, which will usually take 3-5CVs.

 • Load and wash: load sample according to binding capacity of the processing. Wash column with buffer till UV absorbance approaches baseline.

 • Gradient elution: increase salt concentration in linear or step-wise format, elute substances from column according to different binding strength, collect fractions.

 • Regeneration: Wash with high salinity solution (e.g. 1~2M NaCl, 0.1~0.5M NaOH). Wash with buffer till it is neutral.

Fig.2 The flowchart of IEX chromatography

Key points of process optimization

• Choose the right resin and bead size

 • Optimized buffer pH and buffer ionic strength

 • Optimized parameters including elution methods and conditions for better separation.

As quality requirements for bio-products consistently improves, R&D of IEX resin and processing switches from ”standardized processing” to “refined control”.

The composition and classification of IEX resins

Composition

IEX resins consist of matrix and ligands.

Fig.3 The composition of IEX resin

Classification

Based on the ligands, IEX resins fall into two categories:

 • Cation Exchange Resins：Negatively charged ligands, bind to positively charged molecules. E.g. Sulfonic acid (SP), carboxyl group(CM)

 • Anion Exchange Resins： Positively charged ligands, bind to negatively charged molecules. E.g. Quaternary amine (Q), diethylaminoethyl (DEAE)

In addition, adaption of ligands at different pH condition shall be determined based on dissociation degree of ligands at different pH condition as well as ionic strength of ligands.

Table 1. Characteristics of IEX resins

Tips for application

 • Choose strong IEX resins when wider pH stability and higher binding strength are required.

 • Choose weak IEX resins when better selection and milder B/E conditions are required.

 • Strong IEX resins are intended for standard processing operation on scale-up, while weak IEX resins are intended for purification of specific proteins.

IEX resins from Bestchrom

Bestchrom offers a wide range of IEX resins for different applications.

Table 2. Bestchrom IEX resins

Application

IEX is widely used in the following applications:

 • Intermediate and polishing of antibody, for the removal of impurities.

 • The removal of virus-related impurities in vaccine production

 • The efficient capture of recombinant proteins.

Case Study

Diamond CD-S resin used for the purification of mAb

 • Sample：mAb，pH5.0，conductance 4mS/cm

 • Buffer A：50mM NaAc-HAc，pH5.0，Cond：4mS/cm

 • Buffer B：50mM NaAc-HAc + 0.5M NaCl，pH5.0

 • Buffer C：0.5M NaOH

 • Column：Diamond CD-S

 • Column size：BHR 5/17，2mL，bed height 10cm

 • Flow：6RT

Fig.4 Diamond CD-S chromatogram

NUPTEC Product Page

Results

Table 3.Results

Conclusion

In the downstream bioprocessing, IEX resins are both useful tools for separation, as well as efficient solutions to quality products with high purity. A good understanding and mastery of it is a compulsory course for bioprocessing developers.

Bestchrom provides Diamond CD-S and MegaPoly BXS resins for the efficient, accurate and stable purification of mAb, BsAb and ADC, contributing to the process optimization and cost reduction of biopharmaceuticals.

Bio-separation And Purification Resin Market size is estimated to be USD 5.67 Billion in and is expected to reach USD 9.82 Billion by at a CAGR of 6.5% from to .

The Bio-separation and Purification Resin Market is experiencing notable shifts due to AI, automation, and tariffs. AI and automation have enhanced efficiency, accuracy, and scalability in bio-separation processes, increasing the demand for advanced resins. These technologies streamline production and reduce operational costs, driving market growth. However, tariffs, especially on raw materials, have introduced volatility in resin prices, potentially affecting market dynamics by limiting the availability of cost-effective resources. The balance between innovation-driven growth and tariff-related constraints is crucial for the market's future trajectory.

What are the primary factors raising the market trends in the Bio-separation and Purification Resin Market?

Several factors are contributing to the growing demand in the Bio-separation and Purification Resin Market. The increasing demand for high-purity biopharmaceuticals is driving the adoption of advanced resins. Furthermore, rising investments in biotechnology and the growing need for efficient separation techniques in industries like healthcare and food & beverage are expanding the market's scope. Automation and AI integration have improved resin manufacturing processes, leading to more precise and faster bio-separation. Additionally, the demand for environmentally friendly and sustainable solutions has led to the development of greener resins, adding momentum to market trends. Moreover, the rising prevalence of chronic diseases globally is accelerating the need for efficient bioprocessing technologies. These factors combined are creating a robust market environment with significant growth potential.

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What technological innovations are impacting the growth of the Bio-separation and Purification Resin Market?

Technological innovations are playing a crucial role in the Bio-separation and Purification Resin Market. The integration of AI and machine learning into bioprocessing has enhanced the precision of resin applications, making the separation process more efficient and reducing human error. Moreover, the development of novel bio-resins designed for specific purification tasks is improving the yield and quality of bio-products. Automation has significantly reduced labor costs while increasing throughput, further driving market growth. Research into sustainable and recyclable resins is gaining traction, catering to the growing demand for eco-friendly products. In addition, advancements in resin manufacturing techniques, such as continuous chromatography and simulated moving bed technology, have improved resin performance, leading to faster, more cost-effective separations. These innovations are not only meeting the needs of the biopharmaceutical industry but also expanding the applicability of resins across various industries, thereby supporting the market's expansion.

Who are the largest manufacturers in the Bio-separation And Purification Resin Market?

• ThermoFisher
• MERCK
• Agilent
• GE Healthcare
• LANXESS
• YMC
• Bio-Rad
• Tosoh Corporation
• Bio-Works
• Bestchrom (Shanghai) Biosciences Ltd
• Sartorius
• Bestion
• NovoBiotechnology Co
• Ltd
• Yeasen Biotechnology (Shanghai) Co.
• Ltd
• Sunresin
• Nanjing Detai Bioengineering Co.
• Ltd

Dynamic innovation and strategic positioning define the competitive environment of the Bio-separation And Purification Resin Market focus on differentiate themselves through price strategies, product development, and customer experience. Players in this market are using technology advancements and data-driven insights to stay ahead of the competition. The increasing importance of customer-centric strategies and tailored solutions has also led to the emergence of specialized products.

Get an In-Depth Research Analysis of the Bio-separation And Purification Resin Market

What are the factors driving the growth of the Bio-separation And Purification Resin Market?

The Bio-separation And Purification Resin Market has grown as a direct result of the increasing demand for below applications worldwide. A wide range of product types tailored to specific applications, end-user industries from a variety of sectors, and a geographically diverse landscape that includes Asia-Pacific, Latin America, North America, Europe, the Middle East, and Africa are some of the characteristics that set the Bio-separation And Purification Resin Market apart. 

By Type of Resin

• Ionic Exchange Resins
• Affinity Resins
• Mixed-Mode Resins
• Adsorption Resins
• Size Exclusion Resins

By Application

• Biopharmaceuticals
• Food & Beverage
• Water Treatment
• Industrial Chemicals
• Diagnostics

By End Use Industry

• Pharmaceuticals
• Biotechnology
• Chemicals
• Environment & Waste Management
• Cosmetics & Personal Care

By Formulation

• Liquid Phase Resins
• Solid Phase Resins
• Continuous-Flow Resins
• Batch Process Resins
• Hy-id Resins

By Scale of Operation

• Laboratory Scale
• Pilot Scale
• Industrial Scale
• Commercial Scale
• Custom Scale Solutions

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The report offers analysis on the following aspects:

(1) Market Penetration: Comprehensive information on the product portfolios of the top players in the Bio-separation And Purification Resin Market.

(2) Product Development/Innovation: Detailed insights on the upcoming technologies, R&D activities, and product launches in the Bio-separation And Purification Resin Market.

(3) Competitive Assessment: In-depth assessment of the market strategies, geographic and business segments of the leading players in the market.

(4) Market Development: Comprehensive information about emerging markets. This report analyzes the market for various segments across geographies.

(5) Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the Bio-separation And Purification Resin Market.

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This Bio-separation And Purification Resin Market Report Contains Answers to your following Questions

1. What are the present scale and future growth prospects of the Bio-separation And Purification Resin Market?

Answer: Bio-separation And Purification Resin Market size is estimated to be USD 5.67 Billion in and is expected to reach USD 9.82 Billion by at a CAGR of 6.5% from to .

2. What is the current state of the Bio-separation And Purification Resin Market?

Answer: According to the latest data, the intelligent farming market is experiencing growth, stability, and challenges.

3. What factors are driving the growth of the Bio-separation And Purification Resin Market?

Answer: The growth of the Bio-separation And Purification Resin Market can be attributed to factors such as key drivers, technological advancements, increasing demand, and regulatory support.

4. Are there any challenges affecting the Bio-separation And Purification Resin Market?

Answer: The Bio-separation And Purification Resin Market's challenges include competition, regulatory hurdles, and economic factors.

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