Home > SERVICES > Bispecific Antibody (BsAb) Purification

Bispecific Antibody (BsAb) Purification

Bispecific Antibody (BsAb) Purification Service

Your Trusted Partner for Optimal Purity and Yield

This detailed service guide covers key aspects of purifying complex bsAb formats, helping your products achieve exceptional levels of purity, stability, and functionality. With advanced purification strategies customized for diverse research projects, Creative Biolabs is here to help you meet stringent quality standards and accelerate your research and development progress.

Get a Quote Now
OUR METHODS Service Workflow Platforms Why Choose US? FAQs Resources
 Bispecific Antibody (BsAb) Purification

Bispecific antibodies (BsAbs) exhibit enhanced therapeutic effects over traditional monoclonal antibodies. However, achieving a high-quality bsAb product requires not only expert design and engineering but also robust and reliable purification processes to meet clinical standards. Due to the structural complexity and heterogeneity of bsAbs, purification presents unique challenges. The production of bsAbs often results in unwanted forms, including mismatched chains, aggregates, and non-functional variants, making separation and purification difficult. Advanced strategies are required to isolate correctly assembled bsAbs from byproducts that exhibit similar physicochemical properties.

At Creative Biolabs, we address these challenges with specialized purification techniques optimized for each client's configuration of symmetric, asymmetric, or fragment-based bsAbs. Our services include affinity chromatography-based capture, and charge, size, hydrophobicity and mixed-mode-based separation methods to ensure high purity and yield. With extensive experience in handling complex biologics, our team ensures that purified bsAbs are compatible with downstream processes such as formulation and sterile filtration, facilitating seamless transitions to clinical manufacturing.

OUR Methods

Creative Biolabs employs a customized combination of purification methods, including capture steps and polishing procedures, to optimize the success of each project. Regardless of the bsAb format, our optimized workflow guarantees high purity and yield, meeting the specific requirements of each product. With extensive expertise in handling various bsAb configurations, we ensure efficient purification that supports seamless downstream applications and accelerates project timelines.

Type of Affinity Chromatography Principle
Protein A Protein A specifically binds to the Fc region of IgG antibodies, facilitating separation of IgG from non-antibody components. Binding is typically stable at neutral pH, while elution is achieved by lowering pH.
Protein G Protein G binds specifically to the Fc regions of IgG subclasses and certain polyclonal antibodies. It offers higher binding affinity for certain IgG subclasses than Protein A.
Protein L Protein L binds to the kappa light chains of antibodies, making it suitable for purifying Fab fragments, scFvs, and other non-Fc antibodies.
HRPO (Horseradish Peroxidase) HRP is conjugated to antibodies for detection purposes. It reacts with substrates like TMB or DAB, creating a colorimetric or chemiluminescent signal, which can be used to track bispecific antibodies during purification or in bioassays.
IMAC (Immobilized Metal Affinity Chromatography) Metal ions (e.g., Ni²⁺, Co²⁺) immobilized on the resin bind to histidine residues on the target protein or antibody fragment. Elution is achieved with imidazole or acidic buffers.
Charge-based separation (Ion-Exchange Chromatography - IEX) Charged molecules bind to oppositely charged ligands on the stationary phase. Elution is achieved by changing the pH or ionic strength of the mobile phase.
Size-based separation (Size-Exclusion Chromatography - SEC) Molecules are separated based on their size as they pass through a porous matrix. Small molecules enter the pores, while large molecules are excluded and elute faster.
Hydrophobicity-based separation (Hydrophobic Interaction Chromatography - HIC) Hydrophobic proteins bind to a hydrophobic resin in high salt concentrations. Elution occurs by decreasing the salt concentration, reducing hydrophobic interactions.
Mixed-mode-based purification (Mixed-Mode Chromatography - MMC) Mixed-mode ligands interact with target molecules through hydrophobic, ionic, and hydrogen bonding simultaneously. Elution is achieved through changes in salt concentration or pH.

SERVICE WORKFLOW

Project Consultation and Design
  • Collaborate with clients to understand the specific bispecific antibody (BsAb) format and project requirements.
  • Design a tailored purification strategy based on antibody structure, binding properties, and production scale.
  • Establish timelines and quality control checkpoints for the purification process.
1
2
Sample Preparation
  • Receive BsAb samples from clients or coordinate production within Creative Biolabs' facilities.
  • Perform initial quality checks (e.g., concentration, aggregation analysis) to ensure the sample is ready for purification.
Capture Step – Primary Purification
  • Use affinity chromatography (e.g., Protein A, Protein G, or IMAC) to isolate the target bispecific antibody.
  • Remove major impurities, including host cell proteins, DNA, and process-related contaminants.
  • Collect eluate fractions for further processing.
3
4
Polishing Step – Secondary Purification
  • Apply advanced purification techniques such as Ion-Exchange Chromatography (IEX), Size-Exclusion Chromatography (SEC), or Hydrophobic Interaction Chromatography (HIC).
  • Refine the product to remove aggregates, isoforms, and residual impurities.
Quality Control and Analysis
  • Conduct rigorous analytical testing, including SDS-PAGE, HPLC, mass spectrometry, and bioassays, to verify purity and functionality.
  • Provide clients with a detailed certificate of analysis (COA) for each purified batch.
5
6
Packaging and Delivery
  • Package purified antibodies according to regulatory and client-specific guidelines.
  • Coordinate secure and temperature-controlled shipping to ensure product integrity upon delivery.

PLATFORMS

At Creative Biolabs, we utilize advanced instrumentation to offer precise and scalable bispecific antibody purification services. Our platforms, including but not limited to the ÄKTA avant™ chromatography system, Q Exactive™ Plus mass spectrometry, and Agilent Infinity III HPLC, are tailored to address the complexities of various bsAb formats, ensuring high purity and optimal yields. Our comprehensive platform validation and quality control processes guarantee consistent results and meet the stringent requirements of regulatory authorities.

Each phase of the purification process, from automated chromatography to high-resolution mass spectrometry and buffer exchange, is powered by state-of-the-art equipment. These tools enable real-time monitoring, detailed characterization, and seamless scalability, ensuring reliable performance throughout research and clinical production stages. Additionally, our integrated data analysis capabilities and dedicated technical support ensure optimal process parameters and reproducible results for every project.

WHY CHOOSE US?

At Creative Biolabs, we offer a unique blend of expertise, innovation, and customization for bispecific antibody purification services, making us an experienced partner for your bsAb development needs.

Comprehensive Expertise Across bsAb Formats

Creative Biolabs has extensive experience in handling diverse bispecific antibody formats. Each format presents unique structural challenges, but our tailored purification strategies ensure optimal recovery, purity, and functionality, regardless of the complexity of the molecule.

Customized Two-Step Purification Process

We implement a robust two-step purification process for every project. The first capture step isolates the target bispecific antibody, which is followed by polishing steps to remove aggregates, byproducts, and residual impurities, ensuring high-purity antibodies suitable for clinical applications.

Advanced Purification Technologies and Analytical Tools

Our state-of-the-art purification platforms employ advanced chromatography techniques, including mixed-mode purification for challenging protein mixtures. Complemented by sophisticated analytical methods such as HPLC, we guarantee the integrity and consistency of the final product.

Optimized Yield Without Compromising Quality

We understand the importance of both yield and purity in antibody production. Our processes are optimized to maximize recovery without compromising on quality, ensuring that clients receive high-performing bispecific antibodies that meet regulatory and application-specific standards.

Rigorous Quality Control and Documentation

Every purified batch undergoes thorough quality control, with detailed testing to confirm purity, functionality, and stability. We provide a comprehensive certificate of analysis (COA) with every delivery, ensuring transparency and compliance with industry standards.

Rapid Turnaround with Flexible Scale-Up Options

Our streamlined purification workflows and dedicated project management ensure quick turnaround times without compromising quality. We offer flexible scale-up options from small-scale process development to large-scale production, supporting clients through different stages of their development pipeline.

"We worked with Creative Biolabs to purify an IgG-like bispecific antibody from our CHO cell culture supernatant. The sample had significant aggregation issues, but their team applied SEC as a polishing step, and the final product was over 98% pure. What stood out was their ability to recover a high yield despite initial challenges. The detailed Certificate of Analysis (COA) they provided gave us complete confidence in the product’s quality."

— Dr. Sarah Mitchell – Principal Scientist

"Our project involved a tandem scFv bispecific antibody, which we knew would be tricky to purify. The team at Creative Biolabs designed a custom workflow using Protein L capture followed by ion-exchange chromatography to separate isoforms. They kept us informed at every stage and provided regular data updates. The final antibodies were not only pure but also functionally intact, which was critical for our downstream assays."

— Michael Turner – Senior Research Associate

"We initially engaged Creative Biolabs for small-scale purification of a bsAb molecule for early-stage research. Their process was so efficient that we quickly scaled up for preclinical studies. The tangential flow filtration system they used ensured smooth buffer exchange without affecting antibody stability. The consistency between batches was impressive, and the transition to larger volumes was seamless, with no drop in purity or yield."

— Dr. Emily Roberts – Director, Preclinical Development

Get a Quote Now

Experience industry-leading bispecific antibody BsAb purification services—contact us today for professional consultation and customized solutions.

FREQUENTLY ASKED QUESTIONS

What information or materials do I need to provide to start the CAR design process?
To initiate the CAR design and construction process, we typically require a few key pieces of information. First, we need details about the specific target antigen or antigens you want to address. If you have any data on the antigen’s expression profile or binding characteristics, that would be extremely helpful. Additionally, sharing any preferences regarding the structure of the CAR (e.g., co-stimulatory domains, signaling domains, or transmembrane regions) allows us to customize the design more effectively. If you have existing sequences for the antigen-binding domain (such as an scFv) or previous constructs you’ve worked on, providing those sequences can help accelerate the process. If you’re starting from scratch, don’t worry—we can also assist with identifying the appropriate components for your CAR based on your therapeutic or research goals.
What deliverables can I expect from your CAR design and construction service?
Our CAR design and construction service provides a comprehensive set of deliverables to ensure you have everything you need to move forward with your project. You will receive a fully optimized CAR construct that includes the gene sequence of the entire CAR, designed according to your specifications. We also offer gene sequence optimization to improve expression and reduce potential immunogenicity. Depending on your needs, we can provide the CAR in different vector formats, such as plasmid, lentiviral, or adenoviral vectors, which are fully validated for functionality. Additionally, you will receive detailed reports on sequence verification (e.g., Sanger or next-generation sequencing), expression validation (using methods like flow cytometry or Western blot), and functional testing results, such as cytotoxicity assays. These deliverables give you a fully functional and validated CAR, ready for further in vitro or in vivo studies.
Can I select specific services or customize the package based on my needs?
Yes, our services are fully customizable to fit the unique requirements of your project. Whether you need only a specific aspect of the CAR-T development process—such as the design of the CAR structure, vector construction, or validation testing—we can provide standalone services. For example, if you have already designed your own CAR but need assistance with cloning and vector construction, we can handle that part of the process. Alternatively, if you need a complete solution from design to functional validation, we can offer an end-to-end service. You are not locked into a one-size-fits-all package. We encourage clients to discuss their specific goals and challenges with our team so we can create a custom service plan that suits their budget and timelines.
How will I be involved in the design and development process?
Our approach to CAR design and construction is highly collaborative, ensuring that you are actively involved at every critical step of the process. From the initial consultation, we work closely with you to understand your project’s objectives, therapeutic targets, and any preferences you have for the CAR’s structure. Throughout the design phase, we will provide regular updates and involve you in key decisions, such as selecting co-stimulatory domains, antigen-binding regions, and vector options. As the project progresses, you will receive milestone reports, and we will schedule review meetings to discuss any necessary adjustments. This level of engagement ensures that the final CAR construct fully aligns with your expectations and research goals. Your feedback is valuable at every stage, and our team is always available to answer questions and make modifications as needed.
Are there options to scale up the production of CAR constructs after initial design and validation?
Yes, we offer scalable solutions that can support your project as it moves from research and development into preclinical or clinical phases. Once your CAR design has been finalized and validated, we can assist with scaling up production based on your specific needs. For example, if you require large-scale plasmid production for further in vitro testing or therapeutic applications, we offer high-quality plasmid preparation in various purity grades. Additionally, we provide viral packaging services, such as lentiviral and adenoviral production, which are suitable for both small-scale studies and larger-scale applications. Our team can help you transition smoothly to higher quantities of CAR constructs for preclinical studies or clinical-grade production. Furthermore, we ensure that all large-scale products undergo the same rigorous quality control and validation processes to maintain consistency and reliability as your project scales.

RELATED RESOURCES

Online Inquiry