34 results about "Good manufacturing practice" patented technology

The embodiment of the invention discloses a medicine production quality management specification GMP file generation method and related products. The method comprises the following steps: obtaining a content page of a target GMP file drawn by a dragger by using a content template, metadata information of the target GMP file and approval information for the content page; obtaining an endorsement page template and a header and footer template; generating an endorsement page based on the approval information and the endorsement page template; based on the metadata information and the header and footer template, generating a header and a footer; and synthesizing the target GMP file based on the content page, the endorsement page, the page header and the page footer. According to the embodiment of the invention, the signing efficiency of the GMP file can be improved.

The utility model provides a three-door interlocking and timer linkage device, which comprises a self-cleaning area three-room door, an interlocking and timer control circuit, the self-cleaning area three-room door comprises an unpacking room door, an airlock room door and a clean corridor door, a timer is arranged in a wall for separating an unpacking room and an airlock room, the front and back surfaces of the timer are provided with display screens, the two surfaces are visible, and the interlocking and timer control circuit is connected with the interlocking and timer control circuit. When materials enter the airlock room door and the clean corridor door and are closed at the same time, countdown is started after an instruction is received, the airlock room door or the clean corridor door can be opened after countdown is finished, interlocking of the three doors is achieved, personnel cannot open the doors at will to enter a self-cleaning area of a workshop, the two doors cannot be opened at the same time, cross contamination of the materials is effectively avoided, and the service life of the airlock room door and the clean corridor door is prolonged. And the added timer is interlocked and linked with the three doors, so that materials can be self-cleaned for a certain time in an environment in which the airlock is completely closed, the requirement of GMP (Good Manufacturing Practice) is met, the manual operation steps are reduced, and the production efficiency is improved.

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.

Provided herein are methods of producing plasmid libraries according to Current Good Manufacturing Practice (cGMP) guidelines.

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.

The utility model discloses a filling device with a non-return needle head. The filling device comprises a filling machine, filling equipment connected to the filling machine and a driving structure connected with the filling equipment, the filling equipment comprises a filling needle head and a conveying pipe which is communicated with one end of the filling needle head and is connected with a liquid medicine source; the filling needle head is a non-return needle head which is internally provided with a Tesla valve structure; the driving structure comprises a peristaltic pump arranged on the conveying pipe and a driving piece suitable for driving the peristaltic pump to start and stop running. When the filling is finished and the valve is closed, the filling needle head generates strong reverse flow resistance by virtue of the fine Tesla valve structure flow channel design inside the filling needle head, so that the one-way flow speed is increased, the backflow phenomenon of liquid medicine caused by inertia is effectively restrained, the filling precision is improved, the material waste is reduced, and the production cost is reduced. The uniformity of each batch of products is further ensured, the strict requirements of good production specifications are met, and the stability and accuracy of liquid medicine conveying are jointly ensured in cooperation with the use of a peristaltic pump.

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.

This invention relates to flexible, walk-in process units intended for the pharmaceutical industry, characterized by their design according to the principles of Industry 4.0 (integration of intelligent digital technologies into manufacturing processes, including IoT networks, artificial intelligence, big data, robotics, and automation) and continuous manufacturing. This system establishes a flexible production environment that ensures consistent manufacturing processes while guaranteeing strict adherence to Good Manufacturing Practice (GMP) standards. A single control unit manages all process units, including production, room control, and HVAC, enabling seamless interaction with other process units. The system allows for rapid adaptation to market fluctuations, efficient production, and improved product quality, thereby reducing costs and production times.The integrated control unit manages the entire production process, ensuring flexibility and efficiency while maintaining or improving product quality. The modular approach enables market adaptation, efficient production, and faster scaling of the production process. Overall, this patent protects a pharmaceutical production facility with flexible, walk-in process units, providing the company with a competitive advantage.

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.

To provide a tissue replacement implant that is clinically effective for treatment of a variety of retinal diseases and retinal dysfunction, and can be produced using Good Manufacturing Practice (GMP) / clinical-grade manufacturing, and a method of treating a subject.SOLUTION: Tissue replacement implants are provided that include polarized retinal pigment epithelial cells on a poly(lactic-co-glycolic acid) (PLGA) scaffold. The PLGA scaffold is 20-30 microns in thickness, and has a DL-lactide / glycotide ratio of about 1:1, an average pore size of less than about 1 micron, and a fiber diameter of about 150 to about 650 nm.SELECTED DRAWING: None

The present disclosure provides methods for generating and / or purifying secretomes, extracellular vesicles, and fractions thereof, from progenitor cells; and provides compositions containing such generated secretomes, extracellular vesicles, and fractions thereof. The present disclosure further provides methods for analyzing activities, and the functionality and potency, of such secretomes, extracellular vesicles, and fractions thereof. The present disclosure also relates to the therapeutic use of secretomes, extracellular vesicles, and fractions thereof. The present disclosure further relates to good manufacturing practices (GMP)-ready, scalable, culture protocol for the release of clinic-ready secretomes.

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.

Documentation of pharmaceutical operations is typically performed as a combination of paper and electronic records. As a result of good manufacturing practice guidelines, operators constantly move between reading, executing, and documenting. The present disclosure describes a method of handsfree accessing and updating of data during execution of operations, using an extended reality (XR) device. The XR device enables verification of an operator's identity, and connection to a private cloud. A task is initiated by the operator or a third-party user, and the task identifier is sent to the cloud. The cloud retrieves and sends the associated data cluster. The display-only fields of the data cluster are displayed on the screen. The editable fields of the data cluster are presented in specific forms, and the operator uses voice commands to fill in each field. The software sends the updated data cluster to the cloud to replace the original data cluster.

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.

Disclosed herein are methods of utilizing and forming suspension cultures of pluripotent stem cells (PSC), and differentiated cells, spheroids and organoids derived from PSCs (e.g., at industrial efficiency and / or scalability), and compositions comprising the same. These methods may be performed in suspension culture, without the use of basement membrane matrices, during PSC maintenance and expansion, as well as during differentiation of PSCs into differentiated cells and organoids, for example definitive endoderm (DE), hindgut spheroids (HGS), and intestinal organoids (IO). In some aspects, the methods may be xeno-free, and may be performed as per Good Manufacturing Practices (GMP). Also disclosed herein are methods controlling the polarity of epithelial cells in IOs, wherein the apical layer is oriented to the outside of the organoid, or alternatively to the inside of the organoid. Also disclosed are uses of the methods and compositions for transplantation and treatment.

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.

Described herein are methods of episomal reprogramming of isolated cell fraction from cord blood units and generation of induced pluripotent stem cells. The methods are in accordance with current good manufacturing practices.

The utility model discloses an energy-saving vertical hot-pressing distilled water machine which comprises an evaporator, a steam residual water preheater, a condensed water preheater, an injection water buffer tank, an injection water pump, an injection water preheater, a non-condensable gas preheater, a steam preheater and a secondary steam-water separation tank, the position, corresponding to the steam-water separation chamber, of the evaporator is connected with an air inlet of the secondary steam-water separation tank through a pure steam pipeline, an air outlet of the secondary steam-water separation tank is connected with the position, corresponding to the evaporation chamber, of the evaporator through the compressor, and the secondary steam-water separation tank is further provided with a condensate water discharge outlet. The utility model better accords with the requirements of the GMP (Good Manufacturing Practice), so that the quality of injection water is more reliable.

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.