Abstract: An apparatus, system, or method for vial seal inspection may be based on three-dimensional data that is representative of at least a portion of a vial seal. More particularly, apparatuses, systems, and methods for vial seal inspection may include at least one laser triangulation sensor.

Abstract: The present disclosure provides compounds of Formula (I) having activity as inhibitors of G12C mutant KRAS protein. This disclosure also provides pharmaceutical compositions comprising the compounds, uses and methods of treating certain disorders, such as cancer, including but not limited to lung, pancreatic and colorectal cancers.

Abstract: An approach for determining material compatibility for components of a drug delivery system is provided that includes using surface zeta-potential analytical method to evaluate surface interactions between a desired molecule and at least one material present within a given IV-bag system.

Abstract: The present invention relates to RNAi constructs for reducing expression of the ASGR1 gene. Methods of using such RNAi constructs to treat or prevent cardiovascular disease, such as coronary artery disease and myocardial infarction, and to reduce serum non-HDL cholesterol levels are also described.

Abstract: Provided herein are processes for synthesizing intermediates useful in preparing Mcl-1 inhibitors. In particular, provided herein are processes for synthesizing compound F, or a salt thereof, wherein R1 and OPG2 are described herein. Compound F can be useful in synthesizing compound A1, or a salt of solvate thereof, and compound A2, or a salt of solvate thereof.

Abstract: Methods of treating gastric cancer or gastroesophageal junction cancer in subjects are described. The methods may comprise administering an anti-FGFR2b antibody to the subject. The methods may further comprise administering a chemotherapy regimen comprising (a) oxaliplatin and capecitabine; or (b) oxaliplatin and S-1 to the subject.

Abstract: The present invention concerns a method for preparing antigen binding proteins specific for PCSK9 with reduced viscosity. The method proceeds by replacing residues in high viscosity variable domain subfamilies with residues in correlating low viscosity subfamilies. The method further comprises substituting residues in the Fc domain with residues associated with low viscosity and adding charged residues to the C-terminus of the Fc domain. The present invention further concerns antigen binding proteins produced by this method.

Abstract: Fixtures for testing elasticity of drug related methods and related methods are disclosed. In accordance with an example, a method of testing the elasticity of a cannula of a drug delivery device includes securing a barrel of the drug delivery device within a fixture such that the cannula fixed to a distal end of the barrel extends out from the fixture. The method includes applying a lateral force to a distal end of the cannula using a strike member to move the distal end of the cannula a threshold distance. The method includes removing the force from the cannula. The method includes determining a final position of the distal end of the cannula after the force has been removed.

Abstract: The present invention provides a compound of formula (I) or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising a compound of the invention, a method for manufacturing compounds of the invention and therapeutic uses thereof.

Abstract: Provided herein are methods of treating cancer comprising a KRAS G12C mutation in a subject in need thereof comprising administering to the subject sotorasib, carboplatin and pemetrexed in amounts effective to treat the cancer.

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: 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: 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: 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.