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Stanley Chung, Jun Tian, Zhijun Tan, Jie Chen, Jongchan Lee, Michael Borys, Zheng Jian Li
Controlling the charge profile of therapeutic protein is a critical challenge in the current quality-by-design (QbD) paradigm, throughout all phases of biologics process development (PD): cell line development, upstream cell culture, recovery process, downstream purification, and analytical characterization. Charge variant profiles may influence efficacy and/or lead to unintended side-effects. Thus, maintaining a consistent charge profile is of tremendous importance, and increasingly, researchers have focused efforts towards developing strategies to mitigate variability during cell culture and to improve separation and detection of charge variants...
March 13, 2018: Biotechnology and Bioengineering
Suryakanta Swain, Rabinarayan Padhy, Bikash Ranjan Jena, Sitty Manohar Babu
BACKGROUND: Quality by Design is associated to the modern, systematic, scientific and novel approach which is concerned with pre-distinct objectives that not only focus on product, process understanding but also leads to process control. It predominantly signifies the design and product improvement and the manufacturing process in order to fulfill the predefined manufactured goods or final products quality characteristics. It is quite essential to identify desire and required product performance report such as Target Product Profile, typical Quality Target Product Profile (QTPP) and Critical Quality attributes (CQA)...
March 8, 2018: Current Drug Discovery Technologies
Micael Karlberg, Moritz von Stosch, Jarka Glassey
In today's biopharmaceutical industries, the lead time to develop and produce a new monoclonal antibody takes years before it can be launched commercially. The reasons lie in the complexity of the monoclonal antibodies and the need for high product quality to ensure clinical safety which has a significant impact on the process development time. Frameworks such as quality by design are becoming widely used by the pharmaceutical industries as they introduce a systematic approach for building quality into the product...
March 7, 2018: Critical Reviews in Biotechnology
Ana L Quiroga-Campano, Nicki Panoskaltsis, Athanasios Mantalaris
Demand for high-value biologics, a rapidly growing pipeline, and pressure from competition, time-to-market and regulators, necessitate novel biomanufacturing approaches, including Quality by Design (QbD) principles and Process Analytical Technologies (PAT), to facilitate accelerated, efficient and effective process development platforms that ensure consistent product quality and reduced lot-to-lot variability. Herein, QbD and PAT principles were incorporated within an innovative in vitro-in silico integrated framework for upstream process development (UPD)...
March 1, 2018: Metabolic Engineering
Juan Du, Yuqi Zhou, Lulu Wang, Juan Zhao, Yangyang Liu, Chunpeng Li, Yancai Wang
A novel nanocrystal dispersible tablets was developed by apply quality by design (QbD) approach in this study. Following Deacetyl Mycoepoxydience (DM) nanosuspensions was prepared by antisolvent precipitation approach; the DM nanocrystal was solidified by freeze-drying method. Following the screening of cryoprotectants for solidification of the nanosuspensions, the physicochemical properties including re-dispersability, mean particle size (MPS), morphology and dissolution behavior of the DM nanocrystal was investigated...
June 1, 2018: Journal of Nanoscience and Nanotechnology
Jaywant Pawar, Dilipkumar Suryawanshi, Kailas Moravkar, Rahul Aware, Vasant Shetty, Mohammed Maniruzzaman, Purnima Amin
The current study investigates the dissolution rate performance of amorphous solid solutions of a poorly water-soluble drug, efavirenz (EFV), in amorphous Soluplus® (SOL) and Kollidon® VA 64 (KVA64) polymeric systems. For the purpose of the study, various formulations with varying drug loadings of 30, 50, and 70% w/w were developed via hot-melt extrusion processing and adopting a Box-Behnken design of experiment (DoE) approach. The polymers were selected based on the Hansen solubility parameter calculation and the prediction of the possible drug-polymer miscibility...
February 9, 2018: Drug Delivery and Translational Research
Md Noushad Javed, Kanchan Kohli, Saima Amin
Statins are widely prescribed for hyperlipidemia, cancer, and Alzheimer's disease but are facing some inherent challenges such as low solubility and drug loading, higher hepatic metabolism, as well as instability at gastric pH. So, relatively higher circulating dose, required for exerting the therapeutic benefits, leads to dose-mediated severe toxicity. Furthermore, due to low biocompatibility, high toxicity, and other regulatory caveats such as product conformity, reproducibility, and stability of conventional formulations as well as preferentially higher bioabsorption of lipids in their favorable cuboidal geometry, enhancement in in vivo biopharmaceutical performance of Rosuvastatin could be well manifested in Quality by Design (QbD) integrated cuboidal-shaped mucoadhesive microcrystalline delivery systems (Limicubes)...
January 31, 2018: AAPS PharmSciTech
Cher Hui Goey, David Bell, Cleo Kontoravdi
Host cell proteins (HCPs) are endogenous impurities, and their proteolytic and binding properties can compromise the integrity, and, hence, the stability and efficacy of recombinant therapeutic proteins such as monoclonal antibodies (mAbs). Nonetheless, purification of mAbs currently presents a challenge because they often co-elute with certain HCP species during the capture step of protein A affinity chromatography. A Quality-by-Design (QbD) strategy to overcome this challenge involves identifying residual HCPs and tracing their source to the harvested cell culture fluid (HCCF) and the corresponding cell culture operating parameters...
January 30, 2018: MAbs
Akbar L Marzan, Rahnuma Tabassum, Basarat Jahan, Mehedi H Asif, Hasan M Reza, Mohsin Kazi, Sultan M Alshehri, Marcel de Matas, Mohammad H Shariare
BACKGROUND: Nano drug delivery systems have the potential to address the challenges of delivering BCS Class II and IV drugs like furosemide. The purpose of the current study is to prepare stable nanosuspension and investigate in vitro dissolution performance of the model compound furosemide using quality by design (QbD) approach. METHODS: Nanosuspension batches with uniform particle size were prepared for furosemide using the antisolvent precipitation method. A quality by design (Qbd) approach was explored to understand the impact of process parameters (stirring time, stirring speed, temperature, and injection rate) and material attributes (drug concentration, stabilizer type, drug: stabilizer ratio, and antisolvent: solvent ratio) on the quality attributes of furosemide nanosuspension using a full factorial experimental design...
January 22, 2018: Current Drug Delivery
D A Schmid, J H J Allum, M Sleptsova, S Gross, J Gaab, A Welge-Lüssen, R Schaefert, W Langewitz
BACKGROUND: We examined whether a program combining cognitive-behavioural therapy (CBT), vestibular rehabilitation (VR) and psychoeducation is equally effective in improving psychometric measures in patients with dizziness independent of a balance deficit. Measures of patients with dizziness only (DO) were compared to those of patients also having a quantified balance deficit (QBD). METHODS: 32 patients (23 female, 9 male) with persistent dizziness were analysed as 2 groups based on stance and gait balance control: those with QBD (pathological balance) or DO (normal balance)...
February 2018: Journal of Psychosomatic Research
Jure Zakrajšek, Katarina Bevc-Černilec, Simona Bohanec, Uroš Urleb
An ultra-performance liquid chromatographic method for simultaneous determination of rosuvastatin and rosuvastatin degradation products was developed and optimized by using fractional factorial experimental design. Optimized method is capable to accurately determine all potential degradation products of rosuvastatin. During the optimization the effect of four chosen chromatographic factors was evaluated. The analytical method operational design region was modeled using Umetrics MODDE software and optimal chromatographic conditions were predicted...
December 2017: Acta Chimica Slovenica
Anurag S Rathore, Deepak Kumar, Nikhil Kateja
Accurate fingerprinting of critical raw materials that have significant impact on process performance and product quality is a necessary precursor for implementation of QbD in process and product development. This article presents a review of major developments in this space in the last 10 years, with a special emphasis on those in last 5 years. A step by step approach for managing raw materials in the QbD paradigm has been proposed. We think that it is necessary for the biotech industry to better manage variability originating from raw materials if holistic implementation of QbD is to be achieved...
January 4, 2018: Current Opinion in Biotechnology
Hiroyuki Yoshino, Yuko Hara, Masafumi Dohi, Kazunari Yamashita, Tadashi Hakomori, Shin-Ichiro Kimura, Yasunori Iwao, Shigeru Itai
Scale-up approaches for film coating process have been established for each type of film coating equipment from thermodynamic and mechanical analyses for several decades. The objective of the present study was to establish a versatile scale-up approach for film coating process applicable to commercial production that is based on critical quality attribute (CQA) using the Quality by Design (QbD) approach and is independent of the equipment used. Experiments on a pilot scale using the Design of Experiment (DoE) approach were performed to find a suitable CQA from surface roughness, contact angle, color difference, and coating film properties by terahertz spectroscopy...
January 5, 2018: AAPS PharmSciTech
W Grymonpré, G Verstraete, V Vanhoorne, J P Remon, T De Beer, C Vervaet
The concept of twin-screw melt granulation (TSMG) has steadily (re)-gained interest in pharmaceutical formulation development as an intermediate step during tablet manufacturing. However, to be considered as a viable processing option for solid oral dosage forms there is a need to understand all critical sources of variability which could affect this granulation technique. The purpose of this study was to provide an in-depth analysis of the continuous TSMG process in order to expose the critical process parameters (CPP) and elucidate the impact of process and formulation parameters on the critical quality attributes (CQA) of granules and tablets during continuous TSMG...
December 14, 2017: European Journal of Pharmaceutics and Biopharmaceutics
Sunita Minz, Ravi Shankar Pandey
Traditional parenteral recombinant hepatitis B virus (HBV) vaccines have effectively reduced the disease burden despite being able to induce seroprotective antibody titers in 5-10% vaccinated individuals (non-responders). Moreover, an estimated 340 million chronic HBV cases are in need of treatment. Development of safe, stable, and more effective hepatitis B vaccine formulation would address these challenges. Recombinant hepatitis B surface antigen (rHBsAg) entrapped solid fat nanoemulsions (SFNs) containing monophosphoryl lipid A (MPLA) that was prepared and optimized by quality by design (QbD) using response surface methodology (RSM), i...
December 14, 2017: AAPS PharmSciTech
Sutirtha N Chowdhury, Pengfei Huo
We introduce the coherent-state mapping ring polymer molecular dynamics (CS-RPMD), a new method that accurately describes electronic non-adiabatic dynamics with explicit nuclear quantization. This new approach is derived by using coherent-state mapping representation for the electronic degrees of freedom (DOF) and the ring-polymer path-integral representation for the nuclear DOF. The CS-RPMD Hamiltonian does not contain any inter-bead coupling term in the state-dependent potential and correctly describes electronic Rabi oscillations...
December 7, 2017: Journal of Chemical Physics
Jian Zhang, Xin Zhang, Yu-An Bi, Gui-Hong Xu, Wen-Zhe Huang, Zhen-Zhong Wang, Wei Xiao
The "design space" method was used to optimize the purification process of Resina Draconis phenol extracts by using the concept of "quality derived from design" (QbD). The content and transfer rate of laurin B and 7,4'-dihydroxyflavone and yield of extract were selected as the critical quality attributes (CQA). Plackett-Burman design showed that the critical process parameters (CPP) were concentration of alkali, the amount of alkali and the temperature of alkali dissolution. Then the Box-Behnken design was used to establish the mathematical model between CQA and CPP...
September 2017: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
Veronika Debevec, Stanko Srčič, Matej Horvat
The quality by design (QbD) paradigm guides the pharmaceutical industry towards improved understanding of products and processes, and at the same time facilitates a high degree of manufacturing and regulatory flexibility throughout the establishment of the design space. This review article presents scientific, statistical and regulatory considerations in design space development. All key development milestones, starting with planning, selection of factors, experimental execution, data analysis, model development and assessment, verification, and validation, and ending with design space submission, are presented and discussed...
March 2018: Drug Development and Industrial Pharmacy
Vijay S Chudiwal, Sadhana Shahi, Swapnil Chudiwal
The objective of the present study was to develop a sustained release gastro-retentive (SRGR) tablet formulation of nicardipine hydrochloride (HCl) for once-a-day dosing using the quality by design (QbD) approach. The quality target product profile of nicardipine HCl SRGR tablet formulation was defined, and critical quality attributes (CQAs) were identified. Potential risk factors were identified using a fish bone diagram and failure mode effect analysis (FMEA) tool and screened by the Plackett-Burman design, and finally nicardipine HCl SRGR tablet formulation was optimized using the Box-Behnken design...
May 2018: Drug Development and Industrial Pharmacy
Gergely Krivan, Stephen Jolles, Eduardo Lopes Granados, Phillipe Paolantonacci, Rabye Ouaja, Ousmane Alfa Cissé, Ewa Bernatowska
Immunoglobulin replacement therapy (IRT) is standard treatment for patients with primary immunodeficiency (PID). Because most of the patients with PID will require long life-time immunoglobulin replacement therapy, the quality of the prescribed products is of utmost importance. The IRT is generally administered either intravenously (abbreviated IVIG), or subcutaneously (abbreviated SCIG). Both routes have been demonstrated to be effective. The preferred route may vary at different times during a given patient's life...
2017: American Journal of Clinical and Experimental Immunology
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