Abstract: A method of distinguishing between proteinaceous and non-proteinaceous particulates in a fluid sample includes the steps of acquiring a brightfield background image of a membrane filter, introducing a fluid sample onto the membrane filter, acquiring a brightfield image of filtered particles resting on the membrane filter, generating a particle mask based on the brightfield background image and the brightfield image of filtered particles, introducing a fluorescent dye onto the membrane filter, detecting fluorescence on the particle mask, and distinguishing between proteinaceous and non-proteinaceous particulates based on the detected fluorescence. A method for detecting other types of particles, such as polysorbate particles, silicone oil or protein monomers is also disclosed.

Abstract: A vacuum manifold for filtration microscopy includes a manifold top having multiple openings, and a capture membrane positioned above and spaced apart from the manifold top, where the capture membrane is configured to deflect into contact with a surface of the manifold top when a negative pressure is applied to the multiple openings. A method for filtration microscopy includes the steps of providing a vacuum manifold including a manifold top having a plurality of openings, and a capture membrane positioned above and spaced apart from the manifold top; applying sample drops to sample spots on the membrane, the sample spots positioned above the plurality of openings; applying a negative pressure to the openings such that the capture membrane contacts a surface of the manifold top; and optically imaging particulates on the capture membrane.

Abstract: A system for characterizing at least one particle from a fluid sample is disclosed. The system includes a filter disposed upstream of an outlet, and a luminaire configured to illuminate the at least one particle at an oblique angle. An imaging device is configured to capture and process images of the illuminated at least one particle as it rests on the filter for characterizing the at least one particle. A system for characterizing at least one particle using bright field illumination is also disclosed. A method for characterizing particulates in a fluid sample using at least one of oblique angle and bright field illumination is also disclosed.

Abstract: A vacuum manifold for filtration microscopy includes a manifold top having multiple openings, and a capture membrane positioned above and spaced apart from the manifold top, where the capture membrane is configured to deflect into contact with a surface of the manifold top when a negative pressure is applied to the multiple openings. A method for filtration microscopy includes the steps of providing a vacuum manifold including a manifold top having a plurality of openings, and a capture membrane positioned above and spaced apart from the manifold top; applying sample drops to sample spots on the membrane, the sample spots positioned above the plurality of openings; applying a negative pressure to the openings such that the capture membrane contacts a surface of the manifold top; and optically imaging particulates on the capture membrane.

Abstract: A system for characterizing at least one particle from a fluid sample is disclosed. The system includes a filter disposed upstream of an outlet, and a luminaire configured to illuminate the at least one particle at an oblique angle. An imaging device is configured to capture and process images of the illuminated at least one particle as it rests on the filter for characterizing the at least one particle. A system for characterizing at least one particle using bright field illumination is also disclosed. A method for characterizing particulates in a fluid sample using at least one of oblique angle and bright field illumination is also disclosed.

Abstract: A system for characterizing at least one particle from a fluid sample is disclosed. The system includes a filter disposed upstream of an outlet, and a luminaire configured to illuminate the at least one particle at an oblique angle. An imaging device is configured to capture and process images of the illuminated at least one particle as it rests on the filter for characterizing the at least one particle. A system for characterizing at least one particle using bright field illumination is also disclosed. A method for characterizing particulates in a fluid sample using at least one of oblique angle and bright field illumination is also disclosed.

Abstract: A vacuum manifold for filtration microscopy includes a manifold top having multiple openings, and a capture membrane positioned above and spaced apart from the manifold top, where the capture membrane is configured to deflect into contact with a surface of the manifold top when a negative pressure is applied to the multiple openings. A method for filtration microscopy includes the steps of providing a vacuum manifold including a manifold top having a plurality of openings, and a capture membrane positioned above and spaced apart from the manifold top; applying sample drops to sample spots on the membrane, the sample spots positioned above the plurality of openings; applying a negative pressure to the openings such that the capture membrane contacts a surface of the manifold top; and optically imaging particulates on the capture membrane.

Abstract: A vacuum manifold for filtration microscopy includes a manifold top having multiple openings, and a capture membrane positioned above and spaced apart from the manifold top, where the capture membrane is configured to deflect into contact with a surface of the manifold top when a negative pressure is applied to the multiple openings. A method for filtration microscopy includes the steps of providing a vacuum manifold including a manifold top having a plurality of openings, and a capture membrane positioned above and spaced apart from the manifold top; applying sample drops to sample spots on the membrane, the sample spots positioned above the plurality of openings; applying a negative pressure to the openings such that the capture membrane contacts a surface of the manifold top; and optically imaging particulates on the capture membrane.

Abstract: A method of distinguishing between proteinaceous and non-proteinaceous particulates in a fluid sample includes the steps of acquiring a brightfield background image of a membrane filter, introducing a fluid sample onto the membrane filter, acquiring a brightfield image of filtered particles resting on the membrane filter, generating a particle mask based on the brightfield background image and the brightfield image of filtered particles, introducing a fluorescent dye onto the membrane filter, detecting fluorescence on the particle mask, and distinguishing between proteinaceous and non-proteinaceous particulates based on the detected fluorescence. A method for detecting other types of particles, such as polysorbate particles, silicone oil or protein monomers is also disclosed.

Abstract: A method of distinguishing between proteinaceous and non-proteinaceous particulates in a fluid sample includes the steps of acquiring a brightfield background image of a membrane filter, introducing a fluid sample onto the membrane filter, acquiring a brightfield image of filtered particles resting on the membrane filter, generating a particle mask based on the brightfield background image and the brightfield image of filtered particles, introducing a fluorescent dye onto the membrane filter, detecting fluorescence on the particle mask, and distinguishing between proteinaceous and non-proteinaceous particulates based on the detected fluorescence. A method for detecting other types of particles, such as polysorbate particles, silicone oil or protein monomers is also disclosed.

Abstract: A vacuum manifold for filtration microscopy includes a manifold top having multiple openings, and a capture membrane positioned above and spaced apart from the manifold top, where the capture membrane is configured to deflect into contact with a surface of the manifold top when a negative pressure is applied to the multiple openings. A method for filtration microscopy includes the steps of providing a vacuum manifold including a manifold top having a plurality of openings, and a capture membrane positioned above and spaced apart from the manifold top; applying sample drops to sample spots on the membrane, the sample spots positioned above the plurality of openings; applying a negative pressure to the openings such that the capture membrane contacts a surface of the manifold top; and optically imaging particulates on the capture membrane.

Abstract: A vacuum manifold for filtration microscopy includes a manifold top having multiple openings, and a capture membrane positioned above and spaced apart from the manifold top, where the capture membrane is configured to deflect into contact with a surface of the manifold top when a negative pressure is applied to the multiple openings. A method for filtration microscopy includes the steps of providing a vacuum manifold including a manifold top having a plurality of openings, and a capture membrane positioned above and spaced apart from the manifold top; applying sample drops to sample spots on the membrane, the sample spots positioned above the plurality of openings; applying a negative pressure to the openings such that the capture membrane contacts a surface of the manifold top; and optically imaging particulates on the capture membrane.

Abstract: A method of distinguishing between proteinaceous and non-proteinaceous particulates in a fluid sample includes the steps of acquiring a brightfield background image of a membrane filter, introducing a fluid sample onto the membrane filter, acquiring a brightfield image of filtered particles resting on the membrane filter, generating a particle mask based on the brightfield background image and the brightfield image of filtered particles, introducing a fluorescent dye onto the membrane filter, detecting fluorescence on the particle mask, and distinguishing between proteinaceous and non-proteinaceous particulates based on the detected fluorescence. A method for detecting other types of particles, such as polysorbate particles, silicone oil or protein monomers is also disclosed.

Abstract: A vacuum manifold for filtration microscopy includes a manifold top having multiple openings, and a capture membrane positioned above and spaced apart from the manifold top, where the capture membrane is configured to deflect into contact with a surface of the manifold top when a negative pressure is applied to the multiple openings. A method for filtration microscopy includes the steps of providing a vacuum manifold including a manifold top having a plurality of openings, and a capture membrane positioned above and spaced apart from the manifold top; applying sample drops to sample spots on the membrane, the sample spots positioned above the plurality of openings; applying a negative pressure to the openings such that the capture membrane contacts a surface of the manifold top; and optically imaging particulates on the capture membrane.

Abstract: A system for characterizing at least one particle from a fluid sample is disclosed. The system includes a filter disposed upstream of an outlet, and a luminaire configured to illuminate the at least one particle at an oblique angle. An imaging device is configured to capture and process images of the illuminated at least one particle as it rests on the filter for characterizing the at least one particle. A system for characterizing at least one particle using bright field illumination is also disclosed. A method for characterizing particulates in a fluid sample using at least one of oblique angle and bright field illumination is also disclosed.