Abstract: A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) complying with at least five of the following parameters determined by using a FT4 powder rheometer: (i) specific basic flow energy of at most 60 mJ/g; (ii) stability index of 0.75 to 1.25; (iii) specific energy of at most 10 mJ/g; (iv) major principle stress at 15 kPa of at most 40; (v) flow function at 15 kPa of at least 1.3; (vi) consolidated bulk density at 15 kPa of at least 0.26 g/mL; (vii) compressibility of at most 47%; and (viii) wall friction angle of at most 40°; (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device; and (c) encapsulating the bottom part, thereby producing a pharmaceutical product.

Abstract: The present invention relates to methods of preparing pharmaceutical products, involving filling active pharmaceutical ingredient powders into pharmaceutical carriers with a vacuum assisted metering and filling device. The methods disclosed herein can be used in a continuous process, such as in a high-throughput process for producing a pharmaceutical product. The present invention further relates to a particular quality of the neat active pharmaceutical ingredient (API) HDM201, i.e. siremadlin, present as succinic acid co-crystal, which can be used in the methods of preparation of the present invention.

Abstract: A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) complying with at least five of the following parameters determined by using a FT4 powder rheometer: (i) specific basic flow energy of at most 60 mJ/g; (ii) stability index of 0.75 to 1.25; (iii) specific energy of at most 10 mJ/g; (iv) major principle stress at 15 kPa of at most 40; (v) flow function at 15 kPa of at least 1.3; (vi) consolidated bulk density at 15 kPa of at least 0.26 g/mL; (vii) compressibility of at most 47%; and (viii) wall friction angle of at most 40°; (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device; and (c) encapsulating the bottom part, thereby producing a pharmaceutical product.

Abstract: Method for transport of suspensions containing mechanically sensitive material with a sample-transporting device comprising transport conduits and at least one system for accelerating a sample or aliquot through the transport conduit from at least two burets.

Abstract: Sampling valve with which samples containing mechanically sensitive material are removed in a sterile manner from a bioreactor, and process analysis system with analysis stations, in particular chromatography systems, biosensors and cell determination devices, permitting automated, sterile removal of a sample from a bioreactor and gentle transport of the sample, containing mechanically sensitive material, in particular cells, to the analysis station.

Abstract: The invention provides an apparatus for discontinuous filtration of a liquid, having a filter station for filtration, a feed line for supplying the liquid to the filter station, and a filter medium movable relative to the station, the filter medium comprising at least two different membranes, which together in the filter station effect multistage filtration. The invention additionally relates to a method for discontinuous filtration of a liquid or for filtering isolated quantities of liquid, comprising: providing a filter station for filtration, the filter station comprising a chamber in which filtration is carried out; moving or transporting a filter medium from a stock into the filter station, the filter medium comprising at least two membranes which are arranged next to one another in the chamber; and supplying the liquid to the chamber, such that the liquid is subjected to multistage filtration through the membranes.

Abstract: Sampling valve with which samples containing mechanically sensitive material are removed in a sterile manner from a bioreactor, and process analysis system with analysis stations, in particular chromatography systems, biosensors and cell determination devices, permitting automated, sterile removal of a sample from a bioreactor and gentle transport of the sample, containing mechanically sensitive material, in particular cells, to the analysis station