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Strategic CMC-Focused Interactions with Regulatory Authorities
The development, design and control of a biopharmaceutical manufacturing process to obtain product of required quality, safety and efficacy, has...
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Seemingly Endless Biomolecular Structural Variants
Compared to chemical drugs, biopharmaceuticals have a highly complex, seemingly endless, biomolecular structural variant profile, especially due to...
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Modification and preparation of four natural hydrogels and their application in biopharmaceutical delivery
Hydrogels possess a unique three-dimensional structure into which many drugs can be incorporated. The hydrogels slow down the release rate of drugs,...
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Risk Management of the Minimum CMC Regulatory Compliance Continuum
The challenge of control of the biopharmaceutical manufacturing process coupled with the complexity of the resulting biopharmaceutical products...
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Indispensable Potency (Biological Activity)
The measurement of potency (strength) is a regulatory requirement for all pharmaceuticals. For chemical drugs, the potency is determined by measuring...
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A critical review of recent trends, and a future perspective of optical spectroscopy as PAT in biopharmaceutical downstream processing
As competition in the biopharmaceutical market gets keener due to the market entry of biosimilars, process analytical technologies (PATs) play an...
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Complex Process-Related Impurity Profiles
Every manufactured human medicine contains residual impurities associated with its manufacturing process. Patient safety risk associated with the...
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FT-IR versus EC-QCL spectroscopy for biopharmaceutical quality assessment with focus on insulin—total protein assay and secondary structure analysis using attenuated total reflection
For the quality control of biopharmaceutical products, which contain proteins as the most important active ingredients, shelf life may be limited due...
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Solubility of lamotrigine in age-specific biorelevant media that simulated the fasted- and fed-conditions of the gastric and intestinal environments in pediatrics and adults: implications for traditional, re-formulated, modified, and new oral formulations
BackgroundLamotrigine is an effective antiseizure medication that can be used in the management of focal and generalized epilepsies in pediatric...
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Inclusion Bodies: Status Quo and Perspectives
Multiple E. coli cultivations, producing recombinant proteins, lead to the formation of inclusion bodies (IBs). IBs historically were considered as...
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Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs
Regulatory compliance is essential for patient protection, and it applies both to Clinical as well as to Chemistry, Manufacturing & Controls (CMC)....
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Chinese Hamster Ovary Cell Line Instability: Causes, Mitigation, and Prediction
Cell line instability is a common problem in biopharmaceutical manufacturing using Chinese hamster ovary (CHO) cells. Cell line instability, which...
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Metaheuristic approaches in biopharmaceutical process development data analysis
There is a growing interest in mining and handling of big data, which has been rapidly accumulating in the repositories of bioprocess industries....
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Regulatory Pathways Impacting Biopharmaceuticals
To obtain market approval from a regulatory authority for a new medicine, manufacturers must first initiate and then complete human clinical trials....
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Mixed-Mode Chromatography and Its Role in Monoclonal Antibody Purification
As the biopharmaceutical industry matures and embraces process intensification methodologies allied to the emergence of newer personalized medicines,...
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Development and evaluation of orbital rocking motion-based single-use cell culture system, the CELBIC® system
The importance of a single-use bioreactor (SUB) is continuously increasing in research and industrial fields for biopharmaceutical production. In...
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Nano-delivery Systems and Therapeutic Applications of Phytodrug Mangiferin
In order to cure a range of ailments, scientists have investigated a number of bioactive antioxidant compounds produced from natural sources....
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Scale-Up of Protein Purification: Downstream Processing Issues
Large-scale chromatography operations continue to occupy the central position in the overall strategy for downstream processing and purification of...
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Cell Culture Models and Nanobiotechnology for Advanced Drug Delivery Research
Cell culture is a term that describes research methods which enable both cells prokaryotic or eukaryotic to grow in physiological environments. In...
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Bioprocess Challenges in Purification of Therapeutic Protein Charge Variants
Biopharmaceuticals are complex therapeutic protein molecules produced in living cells and have been a major driving force for drug development in the...