22 results about "Good manufacturing practice" patented technology

The present invention provides a process for preparing namodenoson. More specifically, the present disclosure provides a simple and high yield process for Good Manufacturing Practice of namodenoson. The process involves the steps of protection, oxidation, chlorination, amination, reaction and final deprotection.

The invention relates to a mesenchymal stem cell serum-free culture medium with limited chemical components as well as application and a method thereof, the serum-free culture medium is completely serum-free and has definite components: all additives are known chemical substances and meet the production requirements of cGMP (Complementary Good Manufacturing Practice); telomere shortening can be obviously delayed; replicative senescence is slowed down by activating TERT expression; the multiplication capacity can also be enhanced; the P10 generation cells still have the active division capacity; multidirectional differentiation is supported; the osteogenic differentiation efficiency is superior to that of a traditional serum-containing system; and the method is suitable for industrial production and clinical transformation.

The present invention provides a process for preparing namodenoson. More specifically, the present disclosure provides a simple and high yield process for Good Manufacturing Practice of namodenoson. The process involves the steps of protection, oxidation, chlorination, amination, reaction and final deprotection.

This document provides a method for preparing plasmid libraries in accordance with current Good Manufacturing Practice (cGMP) guidelines.

The present disclosure provides methods for producing and / or purifying secretomes, extracellular vesicles, and fractions thereof from progenitor cells, and compositions containing such produced secretomes, extracellular vesicles, and fractions thereof. The present disclosure further provides methods for analyzing the activity, functionality, and efficacy of such secretomes, extracellular vesicles, and fractions thereof. The present disclosure also relates to therapeutic uses of secretomes, extracellular vesicles, and fractions thereof. The present disclosure further relates to a scalable, Good Manufacturing Practice (GMP)-compliant culture protocol for releasing clinically usable secretomes.

The invention relates to the technical field of molecular markers and animal genetic breeding, in particular to an SNP (Single Nucleotide Polymorphism) marker capable of influencing the content of IMP or GMP (Good Manufacturing Practice) of pigs and application of the SNP marker. According to the invention, based on three test swinery of American-series purebred landrace, American-series purebred large white pig and American-series purebred Duroc, pig whole genome re-sequencing and GWAS analysis are adopted, 15 SNP markers related to the content of IMP or GMP are researched and determined, and by optimizing the dominant alleles of the SNP, the frequency of the dominant alleles can be increased generation by generation, the content of IMP or GMP can be increased, and the number of SNP markers related to the content of IMP or GMP can be increased. The pig genetic improvement progress is accelerated, so that the economic benefit of breeding pig breeding is effectively improved.

Apparatuses and methods are described herein for processing polynucleotides in a scaled path environment. The apparatuses include optical sensors to monitor operations and to track material usage for good manufacturing practice.

The invention discloses a strong acting force mediated intelligent drug delivery system and a preparation method. The system comprises a core-shell structure carrier matrix, a drug active component, a'main acting force + auxiliary acting force 'strong acting force unit and a surface functional layer, the preparation method comprises the following steps: preparing a mesoporous core layer and a polymer shell layer to form a core-shell carrier, mediating drug loading through a strong acting force unit, and finally modifying a targeting ligand and PEG (Polyethylene Glycol). The system triggers'pulse-slow release 'dual-mode release of a drug through double physiological microenvironment stimulation, a strong acting force unit improves the load stability (the leakage rate in 24 hours is smaller than or equal to 5%, and the encapsulation efficiency is larger than or equal to 75%), and targeting-anti-clearance modification enhances the targeting property (the target site enrichment amount is larger than or equal to 30%) and the circulation time (the half-life period is larger than or equal to 12 h). The preparation process is controllable, the quality control is clear, the requirements of GMP (good manufacturing practice) are met, the drug effect can be improved, the toxic and side effects can be reduced, and the traditional Chinese medicine composition is suitable for clinical transformation and industrialization.

The utility model discloses a stem cell in-vitro dynamic scale amplification device which comprises a box body, the front end of the box body is rotatably connected with a box door, the top of the front end of the box door is fixedly connected with a control screen, the bottom of the rear end of the box body is fixedly connected with two fans, the bottom end of the interior of the box body is fixedly connected with a waste liquid collecting box, and the waste liquid collecting box is fixedly connected with a liquid outlet. A culture environment control system is installed in the box body and comprises a gas environment control module and a temperature environment control module, a plurality of placing plates are fixedly installed on the left side and the right side of the inner wall of the box body, a material placing cavity is formed between the placing plates, and a plurality of layers of culture plates are slidably connected into the material placing cavity; according to the utility model, the stability of a culture environment, the dynamic nature of a culture solution and the initiative of gas exchange are realized, so that cells can obtain better gas exchange, nutrient supplementation and timely discharge of metabolic wastes in the whole culture process, and the cell culture device can quickly adapt to a culture process based on GMP (Good Manufacturing Practice) requirements; and more and healthier culture results can be obtained in a short time.

Apparatuses and methods process polynucleotides in a sealed path environment. The apparatuses include optical sensors to monitor operations and to track material usage for good manufacturing practice.

The invention discloses a collaborative cleaning method and device for multi-parameter cross contamination control, and belongs to the technical field of industrial cleaning. According to the method, the states of pollutants are dynamically monitored through a multi-parameter real-time sensing module (such as a conductivity sensor, a TOC sensor and a turbidity sensor), pollution types (such as organic residues, particulate matter or a biological membrane) are recognized in combination with a data fusion algorithm, and self-adaptive cleaning control is achieved through a collaborative cleaning execution module (comprising a variable-frequency spraying unit, an ultrasonic-assisted unit and an intelligent dosing unit). The device comprises a cleaning cavity, a multi-parameter sensing module, a collaborative execution module and a central control unit, and supports cross contamination risk assessment and dynamic end point judgment. According to the method, the defects of insufficient cleaning, resource waste and insufficient collaboration in the traditional cleaning technology are overcome, the risk of cross contamination can be remarkably reduced by 95% or above, meanwhile, the cleaning efficiency is improved, water, electricity and chemical consumption are saved by 30% or above, and the traceable requirements of laws and regulations such as GMP (Good Manufacturing Practice) and the like are met.

The invention relates to a GMP (Good Manufacturing Practice) continuous counter-current extraction decolorization process method, and belongs to the technical field of GMP preparation processes. Comprising the following steps: providing a GMP crude product aqueous solution and carrying out pretreatment; carrying out continuous countercurrent contact on the pretreated GMP water phase and the functionalized magnetic nanoparticles in extraction equipment, and adsorbing the pigment on the magnetic nanoparticles to obtain a preliminarily decolored GMP water phase; separating the pigment-loaded functionalized magnetic nanoparticles from the preliminarily decolored GMP aqueous phase by applying a magnetic field; carrying out regeneration treatment on the separated functionalized magnetic nanoparticles loaded with the pigment, and returning the regenerated magnetic nanoparticles to the step (b) for recycling; and carrying out post-treatment on the preliminarily decolored GMP water phase to obtain a high-purity GMP product. According to the invention, the problems of contradiction between decoloring efficiency and product yield, discontinuous operation and the like in the prior art are solved.

The utility model discloses a nitrogen low-temperature precise control integrated airflow crushing device special for traditional Chinese medicine, and belongs to the technical field of pharmaceutical equipment. Comprising an air compressor, a gas storage tank, a C-grade precision dust removal filter, a refrigerated dryer, a first T-grade precision dust removal filter, a first A-grade precision oil removal filter, a nitrogen making machine tower A, a nitrogen making machine tower B, a nitrogen buffer tank, a nitrogen storage tank, a pressure valve, a jet mill host, a cyclone separator, a pulse dust collector and an induced draft fan, and a second T-stage precision dust removal filter and a second A-stage precision oil removal filter. The special nitrogen closed-circuit airflow crushing system for the traditional Chinese medicine is developed in a targeted manner, and the traditional Chinese medicine is crushed through the nitrogen group, so that the retention rate of easily oxidized components such as American ginseng saponin and menthol is increased to more than 98.5%, and an intelligent solution conforming to the GMP (Good Manufacturing Practice) standard is provided for traditional Chinese medicine wall-broken decoction pieces and nano preparations.

Disclosed herein are methods for utilizing and forming suspension cultures of pluripotent stem cells (PSCs), and differentiated cells, spheroids, and organoids derived from PSCs (e.g., with industrial efficiency and / or scalability), as well as compositions comprising them. These methods can be carried out in suspension culture without the use of a basement membrane matrix during the maintenance and expansion of PSCs, and during the differentiation of PSCs into differentiated cells and organoids, such as endoderm (DE), hindgut spheroids (HGS), and intestinal organoids (IO). In some embodiments, the methods may be xenofree and may be carried out in accordance with Good Manufacturing Practices (GMP). Also disclosed herein are methods for controlling the polarity of epithelial cells in IOs, such that the apical layer is oriented outside the organoid, or alternatively inside the organoid. The use of methods and compositions for transplantation and therapeutic purposes is also disclosed.

This specification discloses improved methods for expanding cell populations and for producing organoids from pluripotent stem cells, as well as compositions and their uses, compositions comprising amino acid supplementation liquid components that can be used to carry out the Method, and kits comprising components for carrying out the Method and / or for using the products of the Method. These methods can be carried out without requiring heterogeneous and undefined basement membrane matrices for cell culture, thereby enabling a Good Manufacturing Practice (GMP) compliant approach to producing organoids for various uses, such as clinical screening and therapy, including methods for treating liver-related diseases or disorders and methods for screening candidate compounds or compositions for treating them.

The present disclosure relates to a process for the preparation of nanomodnoson of the following formula (I), which process is suitable for large-scale production, for example, in accordance with good production specifications (GMP). The process disclosed by the invention comprises the steps of protection, oxidation, chlorination, amination, reaction, final deprotection and the like.

Apparatuses and methods are described herein for processing polynucleotides in a sealed path environment. The apparatuses include optical sensors to monitor operations and to track material usage for good manufacturing practice.

Microfluidic devices for processing polynucleotides in a sealed path environment and methods of using the same are described herein. These devices include optical sensors to monitor operations and track material usage in order to enable good manufacturing practices.

The invention discloses a gradient drying preparation method for synchronously performing surface baking and glazing on traditional Chinese medicine pills. According to the method, after pill grinding and drawing are completed and the weight of pills reaches the standard, the surface cultivation procedure and the polishing procedure are synchronously carried out in a sugar-coating machine, and uniform coating is achieved by accurately controlling the adding amount of ethyl alcohol and Chinese insect wax and operation parameters of the sugar-coating machine; gradient drying is adopted in the drying link, primary shaping drying is conducted for 80-120 minutes at the temperature of 40-60 DEG C, timed turning is conducted during the period, and then the temperature is increased to 70-80 DEG C for intensified drying for 4 hours or above. According to the traditional Chinese medicine pill prepared by the method, the problem of flaky crystallization after the Chinese wax is dried is effectively avoided, the surface glossiness is obviously improved, the texture is uniform, and the quality indexes such as disintegration time limit meet the GMP (Good Manufacturing Practice) standard. Meanwhile, the production links are reduced through the synchronous process, the drying efficiency is improved through gradient drying, the production cost is reduced, the method has good applicability to various traditional Chinese medicine pills, and a new way is provided for optimizing the traditional Chinese medicine pill production technology.

Apparatuses and methods are described herein for processing polynucleotides in a sealed path environment. The apparatuses include optical sensors to monitor operations and to track material usage for good manufacturing practice.

This utility model relates to pharmaceutical manufacturing, specifically to devices for ensuring the proper fit of gloves in isolators used in the production of sterile dosage forms. The device is designed to comply with Good Manufacturing Practice (GMP) regulations, where gloves should be straightened and fingers spread to ensure full contact with the sterilizing agent. 3 inc. fil., 6 fig., 2 others.

The invention relates to the technical field of culture media, in particular to a GMP (good manufacturing practice)-grade general culture medium for supporting co-culture in-vitro amplification of various primary cells, which comprises a basic culture medium and a special additive, and the basic culture medium comprises a carbon source, a nitrogen source, water, inorganic salt and growth factors; the special additive comprises a serum-free culture medium and a cell interaction regulator. The serum-free culture medium is used for replacing traditional animal-derived serum, so that the activity of cells is not influenced, and the co-culture supporting capability of a plurality of cells can be realized by the culture medium; meanwhile, the serum-free culture medium is adopted, so that animal-derived component pollution wind can be reduced, and the GMP-level standard is met; through the cell interaction regulator, the cell activity and intercellular signal transduction can be regulated to play a role, so that the cell activity can be better maintained, and long-time co-culture of multiple primary cells is ensured.