Amgen

In a method for replicating performance of an automated visual inspection (AVI) station, a mimic AVI station that performs one or more AVI functions of the AVI station is constructed. One or more container images are captured by an imaging system of the AVI station while a container is illuminated by an illumination system of the AVI station, and one or more additional container images are captured by a mimic imaging system of the mimic AVI station. The method also includes identifying, by one or more processors, one or more differences between the one or more additional container images and the one or more container images, generating, by the one or more processors, a visual indication of the difference(s) and/or one or more suggestions for modifying the mimic AVI station, and modifying the mimic AVI station based on the visual indication.

A plunger configured as described herein provides geometry optimizations to minimize friction magnitude and variability during use by maintaining low deformation under large extrusion forces. More specifically, plunger embodiments described herein minimize a contact area between the plunger and a syringe or chamber, while also maintaining high contract pressures to maintain container closure integrity. Moreover, the plunger embodiments are configured to have minimal or no increase in the contact area under high loads associated with the delivery of viscous products.

The present invention provides commercial processes for preparing 2-((3R,5R,6S)-5-(3-chlorophenyl)-6-(4-chlorophenyl)-1-((S)-1-(isopropylsulfonyl)-3-methylbutan-2-yl)-3-methyl-2-oxopiperidin-3-yl)acetic acid as well as intermediates thereof.

The invention relates to the formulation of pharmaceutical compositions of etanercept. The invention relates to methos of removing buffer and of formulating pharmaceutical compositions of etanercept.

Described herein are novel PRMT5 inhibitors of Formula I and pharmaceutically acceptable salts thereof, as well the pharmaceutical compositions thereof. Compounds of the present invention are useful for inhibiting PRMT5 activity and may have use in treating proliferative, metabolic and blood disorders. Compounds of Formula I have the following structure: <img class="EMIRef" id="0b6461e1-14f2-4bab-b207-de52db6c8159-ia01" />

Provided herein are improved methods for measuring the concentration of carfilzomib in a sample. The method comprises the steps of diluting the sample with a diluent comprising water and less than 50% by volume acetonitrile to form an analytical sample; and subjecting the analytical sample to high performance liquid chromatography (HPLC) to determine the carfilzomib concentration in the sample.

A machine for coupling a plunger rod to a syringe assembly may include a carriage including a cradle having a seat portion sized to receive a syringe assembly and an aperture portion disposed above the seat portion and sized to receive a plunger rod. An actuating device may be operatively coupled to the carriage and adapted to move the cradle from a first position to a second position to couple the plunger rod to the syringe assembly. The carriage may be selected from separate and interchangeable first and second carriages, wherein the first carriage includes a cradle adapted to receive a syringe assembly of a first size and the second carriage including a cradle sized to receive a syringe assembly of a second size that is different from the first size.

The invention generally relates to anti-sclerostin antibodies having C-terminal modifications, and compositions comprising such antibodies.

Modular fluid path assemblies are provided that include conduit, coupling, and needle portions of a fluid path fluidly coupled to an outlet of a container. The modular fluid path assemblies further include a needle shield having a tip of the needle embedded therein. So configured, in embodiments, the modular fluid path assemblies can be sterilized, a medicament can be filled in the container, and a stopper inserted in the container so that the pre-sterilized and pre-filled modular fluid path assemblies can have a closed container integrity (CCI) seal.

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