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19 The GMP policy illustrates the procedures Health Canada follows to ensure that all drug establishments comply with GMP guidelines.
Manufacturing hiPSCs should be performed in the Cell Processing Center under the GMP guidelines.
Technological resources are available for large-scale cell encapsulation intended for advanced therapies (gene therapy, somatic cell therapy and tissue engineering) in a cell factory, following GMP guidelines.
In order to apply human embryonic stem cells (hESCs) and induced pluripotent stem cells (hiPSCs) to regenerative medicine, the cells should be produced under restricted conditions conforming to GMP guidelines.
Short peptides are capable of high levels of control, can be manufactured relatively easily in a highly reproducible manner under GMP guidelines and are readily modified to enable their integration with numerous current and emerging chemistries for biomaterials grafting.
A cell-free capsule model was performed following the GMP guidelines: an opaque agent suspension in a bivalent cation solution (Ca2+, Ba2+, Sr2+) was dropped in a sodium alginate solution, obtaining capsules presenting a liquid core surrounded by a gel alginate membrane.
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Our current facility fulfills PIC/s GMP Guideline and USP 〈797〉 Guideline.
At PET Pharm Biotech firm, we have adopted PIC/S guideline and USP 797 guidance for the production, formulation, and dispensing of PET radiopharmaceuticals. Current regulations and quality standards including FDA regulations and CFR, EU-GMP guidelines, WHO-GMP guidelines, and roles of PIC/S in international regulatory affairs are well documented in online resources.
A standard operation procedure (SOP) for DC vaccine production was established according to institutional GMP-based guidelines.
Adjacent rooms of different grades have been maintained with a controlled differential pressure of 10 15 Pascal according to EU guidelines for GMP [ 23].
However, UNICEF does not issue GMP licences nor GMP certificates following these GMP inspections.
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