Abstract: Provided herein are methods of assessing or validating a cleaning procedure of a biotherapeutic manufacturing process, said method comprising analyzing by a surface plasmon resonance (SPR)-based assay the binding activity of a cleaned sample to a ligand which binds to a biotherapeutic produced by the manufacturing process. In various embodiments, the cleaning procedure comprises one or more steps to inactivate and/or degrade the biotherapeutic. In various instances, the method demonstrates that greater than about 99.99% degradation of the therapeutic is achieved by the cleaning procedure comprising the one or more steps to inactivate and/or degrade the biotherapeutic.

Abstract: Methods and systems for determining a viscosity of liquid samples are provided. The methods and systems utilize an acoustic liquid handler. The acoustic liquid handler has a first location adapted to receive a liquid sample. The acoustic liquid handler is configured to apply one or more acoustic signals to the liquid sample in the first location until a specified amount of the liquid sample has been transferred from the first location to a second location of the acoustic liquid handler. The acoustic liquid handler has a controller configured to determine the viscosity of the liquid sample based on a number of acoustic signals required to transfer the specified amount of the liquid sample from the first location to the second location.

Abstract: The disclosure provides methods of purifying native and recombinant biomolecules, e.g., proteins, from mammalian cells using purification protocols incorporating harvest recovery operations involving decanter centrifugation of at least one target biomolecule from at least one particulate component of cell culture fluid. The unexpected capacity of decanter centrifuge separation of biological materials of similar densities found in mammalian cell culture fluid has been found to yield high quantities of functional protein in efficient, low-cost harvest recovery steps of biomolecule purification protocols.

Abstract: The present invention relates to severe acute respiratory syndrome coronavirus 2 (“SARS-CoV2”) immunogens useful for the generation of therapeutic antibodies and vaccine development. Such therapeutic antibodies include human antibodies and antigen-binding portions thereof that specifically bind to human SARS-CoV2 S protein, and that function to neutralize SARS-CoV2. The present invention also relates to methods of generating antibodies and antigen-binding portions thereof that specifically bind to human SARS-CoV2 S protein.

Abstract: Systems and methods of using machine learning for identifying glass breakage events can include (a) accessing or obtaining the machine learning mode, (b) obtaining audio data, (c) determining, by processing the audio data using the machine learning mode, whether a glass breakage event has occurred, and (d) when determined that the glass breakage event has occurred, indicating the glass breakage event has occurred. Methods and instructions for training a machine learning model for identifying a glass breakage event can include (a) obtaining training audio data, (b) classifying the training audio data into a plurality of subsets, and (c) generating the machine learning model for identifying glass breakage events using the classified subsets.

Abstract: A method for facilitating selection of cell lines to advance to a next stage of cell line screening includes receiving first attribute values for the candidate cell lines measured using an opto-electronic cell line generation and analysis system, and acquiring second attribute values that include one or more attribute values measured at a cell pool screening stage of the candidate cell lines. The method also includes determining a ranking of the candidate cell lines according to a product quality attribute associated with hypothetical small-scale screening cultures. Determining the ranking includes predicting, for each of the candidate cell lines, a value of the product quality attribute by analyzing the first and second plurality of attribute values using a machine learning based regression estimator, and comparing the predicted values. The method also includes causing an indication of the ranking to be presented to a user via a user interface.

Abstract: Techniques for determining parameters for a seed train process for growing a culture of cells. The techniques include obtaining a specification of seed train process constraints for multiple stages of the seed train process; determining the seed train process parameters using the seed train process constraints, the seed train process parameters comprising a respective set of parameters for each particular stage of multiple stages of the seed train process; determining, using historical cell growth data and the seed train process parameters, a likelihood indicative of whether performing the seed train process using the seed train process parameters will satisfy seed train process success criteria; and outputting the set of seed train process parameters for each stage of the multiple stages of the seed train process and the likelihood indicative of whether performing the seed train process will satisfy the seed train process success criteria.

Abstract: A syringe holder for a drug delivery device is provided. The syringe holder may include a proximal end, a distal end, and a hollow interior configured to receive at least a portion of a syringe. The syringe holder may further include a side opening distal to the proximal end and an outwardly extending protrusion proximal to the side opening. During assembly of the syringe holder into a housing of the drug delivery device the outwardly extending protrusion may be configured to support the syringe holder at a first axial position or an intermediate position with respect to a longitudinal axis of the housing of the drug delivery device. Also provided is a drug delivery device incorporating a syringe holder and a subassembly for a drug delivery device incorporating a syringe holder. A method of assembling a syringe holder into a housing of a drug delivery device is also provided.

Abstract: A drug delivery device and method of using the same may include a housing having an opening and a drug storage container including a delivery member with an insertion end configured to extend at least partially through the opening. The drug storage container may be coupled with the housing such as to substantially prevent relative movement therebetween. A guard may be positioned adjacent to the opening and operably coupled with the plunger biasing member such that a relative movement between the guard and the housing permits release of a plunger biasing member to urge a plunger in to expel a drug from the drug storage container. A lock component may be configured to resist the relative movement between the guard and the housing until the lock component is released by a user force, whereafter the user force drives the housing and the drug storage container toward an injection site.

Abstract: A cassette for a drug delivery device is described that includes a sleeve, a syringe having a barrel disposed in the sleeve, and a plunger-stopper slidably disposed within the barrel. An end cap is adapted to couple to the sleeve to secure the syringe in the sleeve. The cassette further includes a spacer that is sized to be slidably moved within the barrel and the spacer is disposed distal to the plunger-stopper to be engaged by a plunger rod to slide within the barrel and engage the plunger-stopper. In some forms, the spacer can be coupled to the end cap.

Abstract: A drug delivery device includes a housing, a container at least partially disposed within the housing and configured to contain a medicament, an injection mechanism at least partially disposed within the housing and configured to exert a force to urge the medicament from the container, a drug delivery component at least partially disposed within the housing, and at least one pin positioned adjacent to the housing and preventing activation of the activation mechanism until the at least one pin reaches a desired temperature.

Abstract: A drug delivery device includes a housing, an injection assembly at least partially disposed in the housing, a shield, and a drive assembly at least partially disposed in the housing and coupled with the injection assembly and the shield. The shield has an extended position where at least a proximal end thereof extends a distance beyond a proximal end of the housing. The injection assembly includes a needle or cannula having an endpoint. Upon moving the shield axially towards the distal end of the housing a predetermined distance, a retraction profile commences whereby the drive assembly administers a medicament via the injection assembly. A peak resistance force is exerted within approximately the first 12 mm of axial movement of the shield.

Abstract: A live virus composition that maintains infectivity and provides improved virus stability during one or more freeze/thaw cycles and/or during long term storage in a liquid state at temperatures ranging from just above freezing to ambient temperatures.

Abstract: A drug delivery device assembly is provided, including an injector housing, a needle assembly, a drive assembly, and an alignment accessory. The injector housing may include a body with a proximal end, a distal end, and a longitudinal axis extending between the proximal end and the distal end. The needle assembly is at least partially disposed within the body and may include a syringe barrel containing a medicament and a needle or a cannula. The drive assembly is at least partially disposed within the body and operably coupled with the needle assembly to urge the medicament through the needle or cannula during an injection sequence. The needle or cannula is configured to pierce a patient's skin at an injection site. The alignment accessory includes an accessory body configured to be selectively coupled with the injector housing and an alignment aid configured to aid alignment of the accessory body with respect to the patient's skin at the injection site.

Abstract: The disclosure provides non-steady state continuous perfusion cell culture methods for protein production in bioreactors. Cells are cultured in non-steady state after entering production phase such that the viability declines over time. Production of protein products using these cell culture methods is increased.

Abstract: The disclosure provides systems and methods for detecting and quantifying two or more different antigen-binding proteins in a sample. The systems involve donor beads, acceptor beads, and conjugate proteins, which may be incubated with the sample to quantify the antigen-binding proteins via a proximity-based homogenous assay.

Abstract: Parallel chromatography systems and continuous manufacturing methods are described herein that utilize two or more chromatography column skids having columns operating in parallel with automation controls governing which column to load at a given time.

Abstract: A drug product reconstitution processing system includes a drug vial tray having a plurality of walls, a first robotic arm movable between a plurality of positions above the drug vial tray, and a second robotic arm movable between a plurality of positions above the drug vial tray. The first robotic arm includes a drug vial transfer system adapted to retrieve a drug vial disposed within one of the plurality of wells and a vial agitation system adapted to agitate the drug product contained within the drug vial. The second robotic arm includes a drug vial reconstitution system adapted to selectively add a fluid to the drug vial and/or remove a fluid from the drug vial.

Abstract: Disclosed herein are compounds having activity as inhibitors of Werner Syndrome RecQ DNA helicase (WRN), pharmaceutical compositions comprising the compounds, and methods of treating certain disorders, such as cancer, including but not limited to colorectal, endometrial, gastric and ovarian cancer. In particular, the disclosure provides compounds of Formula (A-I): and pharmaceutically acceptable salts thereof, wherein the substituents are as described herein.

Abstract: This invention relates to combination therapies comprising a Programmed Death 1 receptor (PD-1) pathway inhibitor, and a Leukocyte Immunoglobulin Like Receptor B (LILRB) signaling inhibitor, and the use of the combination therapies for the treatment of cancer. The invention also relates to the treatment of cancer patients who are refractory to monotherapy with a PD-1 pathway inhibitor.