Articles in this Issue
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Cleaning validation is a GMP requirement [1-2] in the pharmaceutical manufacturing of drug substances and drug products. Cleaning verification (CV) must be performed to demonstrate the “cleanliness” of the production equipment [3-4] at the completion of each manufacturing step by visual inspection and the analysis of cleaning swabs or rinse solutions to confirm that the active pharmaceutical ingredient (API) has been adequately removed to pre-established acceptance limits [4-5].
Due to the increasing prevalence of poorly water soluble compounds entering drug development, lipid-based formulations are taking an important role in enhancing the bioavailability of these drugs and bringing them to the marketplace. While they often lead to dramatic increases in drug solubilization, dissolution, and absorption, special challenges can be encountered as they are brought through development.
The definition of an “objectionable organism” has been under intense scrutiny recently. The critical nature of the issue is reflected by its presence in three separate citations in the current cGMP (italics added for emphasis):
Most of the findings on incompliance during FDA inspections involve the handling of raw materials. Even large pharmaceutical companies have received warning letters from the FDA concerning cGMP for raw materials. Using molecular spectroscopy techniques like NIR and Raman provide rapid and accurate identification and statistical verification of raw materials.
The gelatin capsule is a widely used dosage form both for drug products as well as dietary supplements. The capsule can be made of hard or soft gelatin and it can be filled with solids, liquids or semisolids formulations. In the presence of certain compounds such as aldehydes or when exposed to high humidity and temperature, gelatin can crosslink rendering it insoluble in aqueous solvents.
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For recombinant therapeutic protein production, microbial (e.g. E.coli) and mammalian cells (e.g. CHO-cell) are the most important hosts. Progress in producing high value biologics not only depends on improving the performance of the cells but also of the efficiency of their supply in production-scale bioreactors.
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Wet granulation is a widely used process in the pharmaceutical industry since this improves the flow properties, homogeneity and compressibility of the powder mix. Fluidized bed granulators and high shear mixers are typically used in traditional batch wet granulation processes. These two techniques differ from each other in terms of the technique used for solid agitation and on the mode of granule growth, as described by Faure et al. .
X-Ray Powder Diffraction (XRPD) continues to be an indispensable analytical technique supporting a wide variety of pharmaceutical development activities. This Perspective will highlight some of the current developments and emerging technologies of XRPD. For the interested reader, a comprehensive review of pharmaceutical applications of XRPD is available elsewhere .
The need for better drug therapy for newborns, infants, children and youth is beyond debate. Although there is a record of concern about remedies for children dating back to the ‘Boke of Children’ published by Thomas Phaire in 1544 , progress in drug therapy was agonizingly slow until the modern era.
Protein products are commonly dried due to the inadequate stability of proteins in aqueous solution. When a given protein formulation is dried using different drying methods, such as lyophilization, spray drying, or vacuum drying, the resulting products can exhibit large differences in the physico-chemical properties of the solids such as specific surface area (SSA), surface composition and molecular mobility etc .
The advantages for drug developers using prefilled syringes are numerous; improved patient compliance and better cost efficiency, as well as mitigating the risks of drug wastage and product contamination. However, this rapidly expanding area is not without its hurdles.
Bionique Testing Laboratories is an independent contract testing laboratory that is exclusively dedicated to mycoplasma testing. We have been providing mycoplasma testing services and consultation for biopharmaceutical companies, media/sera manufacturers, and research institutions for over 20 years.
What are the most notable challenges
with measuring physiochemical properties
and how is Sirius Analytical working to
overcome these challenges? Accuracy and understanding. We work hard to ensure that the physicochemical properties we measure, pKa, log P, solubility and dissolution rate are properly measured and that the results are accurate and correct.