Micro-Flow Imaging (MFI) Technology

Micro-flow Imagin (MFI) is a well-established and commonly used technique to measure, quantify, visualize and, in some cases, identify (sub)visible particles. The proposed revision of USP Guideline <788> recommends the use of newer analytical techniques such as MFI to resolve sub-visible particles in biologics. CD Formulation's cGMP laboratory, equipped with state-of-the-art MFI instrumentation and breakthrough technology, is dedicated to providing the biopharmaceutical industry with unparalleled MFI-based sub-visible particles (SVPs) characterization services to accelerate protein/peptide biologics development and production processes.

What is Micro-Flow Imaging (MFI)?

MFI is also known as flow imaging microscopy (FIM) or dynamic imaging analysis (DIA). Emerging regulatory guidance states that MFI is a validated method for particle size distribution and an approved method for characterizing particles for a variety of contaminants. MFI uses dynamic imaging for direct particle detection, which can rapidly quantify particle size and shape of tens of thousands of particles per sample and has the sensitivity to detect semi-transparent protein particles.

In MFI, brightfield images are captured as successive frames as a continuous sample stream passes through a flow cell positioned in the field of view of the microscopy system. Digital images of particles present in the sample are processed by image morphology analysis software, allowing their size and number to be quantified.

Fig. 1 Micro-flow imaging instrument configuration. (Tanase M, et al., 2015)

Our Services Related to Micro-Flow Imaging (MFI)

With decades of experience in supporting protein/peptide biopharmaceutical development and manufacturing, our team of highly qualified experts can provide a range of MFI-related services to accelerate the implementation and success of your project.

Protein aggregation and sub-visible particles (SVP) formation can significantly impact the safety and efficacy of biopharmaceuticals. Therefore, protein aggregation and subvisible particle content must be carefully monitored during process development and final product development.

At CD Formulation, our scientists use MFI to address SVPs in biologics to support all stages of your protein/peptide drug development and manufacturing—from early studies to downstream process monitoring and GMP batch release testing.

Our MFI technology uses an image-based approach to determine measurable morphological features from particle images to further understand SVPs in protein formulations. This helps minimize protein aggregation and maintain consistency in size distribution and morphology of the residual particle during formulation development, clinical trials, manufacturing, and storage.

To gain a comprehensive understanding of your product and detect protein aggregates in your samples, we use MFI technology to provide the following services:

• Analysis of SVPs in protein/peptide biologics that meet USP revised requirements.
• Optimize protein/peptide formulations to limit SVP formation, and evaluate and control the impact of process variables on particle formation.
• Protein stability studies to test the effects of storage conditions and excipients on protein/peptide formulations (primarily SVPs).
• Particle characterization of contaminants to distinguish between silica droplets and protein aggregates.
• Characterize formulations after reconstitution of lyophilized protein/peptide products.
• Characterization of aggregates during protein crystallization.
• Characterization of protein/peptide drug delivery microparticles (size of 1-10 micron particles).

Procedure of Our Micro-Flow Imaging (MFI) Technology

• Sample preparation: volume 0.25ml -10ml.
• Display frame images and perform real-time analysis during operation, providing immediate visual feedback on the properties of particle populations in the sample.
• Image analysis. The process relies on a database containing counts, sizes, concentrations, and a range of shape and image contrast parameters. Ultimately providing key information about the particles.

Advantages of Our Micro-Flow Imaging (MFI) Technology

Our MFI technology combines the direct imaging capabilities of digital microscopy with the precise control of microfluidics, with:

• High resolution.
• High sampling efficiency.
• Ability to accurately characterize SVP sizes and complete morphological details.
• Can characterize a variety of SVPs, including protein aggregates, silica droplets, bubbles, etc.
• Real-time imaging and analysis capabilities.
• Size range: 2 to 300 µm.
• Relies on refractive index changes rather than light obstruction, allowing for greater sensitivity to translucent particles such as proteins.

Custom Micro-Flow Imaging (MFI) Services

Why Choose Our Our Micro-Flow Imaging (MFI) Technology?

• We have a team of experts with rich experience in performing MFI analytical method development and validation.
• We have accumulated decades of expertise and successful project experience using MFI technology to support protein/peptide biopharmaceutical development.
• Our laboratories are equipped with state-of-the-art equipment and technologies to support any type of protein characterization.
• We provide flexible experimental design and customized solutions.
• Fast turnaround time: detailed technical reports are provided within 5-7 days.

Publication

CD Formulation aims to provide a powerful analytical tool for measuring potential protein aggregates to support formulation safety and efficacy, as well as long-term stability studies of products. Please feel free to contact us if you are interested in our services. Learn how our MFI technology can support the smooth implementation of your protein/peptide biopharmaceutical program.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.