Kufer, Regina Larraillet, Vincent Thalhauser, Sabrina Graf, Tobias Endesfelder, Manuel Wohlrab, Stefanie
Published in
Journal of pharmaceutical sciences
Host cell protein (HCP) characterization is a crucial quality parameter for biotherapeutic drug safety and stability. With a liquid chromatography-tandem mass spectrometry (LC-MS/MS) approach, we identified ubiquitin in ultrafiltration/diafiltration (UF/DF) pools of one of our monoclonal antibody (mAb) products. Since ubiquitin occurs physiological...
Moharir, Shreyash Khobragade, Prachi Rane, Rajesh Suryawanshi, Mugdha Pal, Kavita Gawade, Bapu Kumar, Dileep Satpute, Bharat
Published in
Journal of pharmaceutical sciences
Our study focuses on creating hybrid compounds and assessing their suitability for use in skincare products. The synergistic combination of Kojic acid, NSAIDs, and Palmitic acid proved to be an effective approach in inhibiting melanin production, making it a promising solution for individuals with hyperpigmentation concerns with Kojic acid (KA) Ibu...
Srai, Jagjit Singh Bauer, Paul Badman, Clive Bresciani, Massimo Cooney, Charles L Florence, Alastair Hausner, Doug Konstantinov, Konstantin Lee, Sau L Mascia, Salvatore
...
Published in
Journal of pharmaceutical sciences
The last decade has seen Advanced Medicines Manufacturing (AMM) progress from isolated product developments to the creation of industry-academic centres of excellence, regulatory innovation progressing leading to new standards, and product commercialisation across multiple product formats. This paper examines these developments focusing on successf...
Salish, Karthik Maurer, Reto Mao, Chen
Published in
Journal of pharmaceutical sciences
Discharge of powder from a hopper or bin is a common operation in solid dosage form manufacture. Powder flow obstruction during hopper/bin discharge, such as arching or ratholing, remains an outstanding risk and cannot be reliably diagnosed using the existing flow function coefficient-based method. In this study, we showed that the major principal ...
Dehghani, Alireza Binder, Florian Zorn, Michael Feigler, Andreas Fischer, Kathrin Inge Felix, Marius Nicolaus Happersberger, Peter Reisinger, Bernd
Published in
Journal of pharmaceutical sciences
Host cell proteins (HCPs) are process-related impurities that can negatively impact the quality of biotherapeutics. Some HCPs possess enzymatic activity and can affect the active pharmaceutical ingredient (API) or excipients such as polysorbates (PS). PSs are a class of non-ionic surfactants commonly used as excipients in biotherapeutics to enhance...
Alam, Qadir Ganeshpurkar, Ankit Singh, Sushil Kumar Krishnamurthy, Sairam
Published in
Journal of pharmaceutical sciences
Dimethyl fumarate (DMF) is an FDA-approved drug for treating relapsing-remitting multiple sclerosis; but it is susceptible to sublimation leading to its loss during processing. Cocrystals can protect against thermal energy via the interaction of DMF with a coformer via weak forces of interaction. With this hypothesis, we have, for the first time, p...
Agbana, Preye Park, Ji Eun Rychahou, Piotr Kim, Kyung-Bo Bae, Younsoo
Published in
Journal of pharmaceutical sciences
Carfilzomib (CFZ) is a second-generation proteasome inhibitor showing great efficacy in multiple myeloma treatment, yet its clinical applications for other diseases such as solid cancers are limited due to low aqueous solubility and poor biostability. Ternary polypeptide nanoparticles (tPNPs) are drug carriers that we previously reported to overcom...
Okada, Kotaro Ono, Takashi Hayashi, Yoshihiro Kumada, Shungo Onuki, Yoshinori
Published in
Journal of pharmaceutical sciences
This study examined the usefulness of 1H T1 relaxation measurements for evaluating the homogeneity of amorphous solid dispersion (ASD). Indomethacin and polyvinylpyrrolidone were used to prepare two kinds of ASDs. One was inhomogeneous ASD (ASDmelt) prepared by a melt-quenching method, and the other was homogeneous ASD (ASDsolvent) prepared by a so...
Bhattacharjee, Arka Chaulya, Nitai Chand Mukhopadhyay, Goutam Chakraborty, Arpan Mondal, Baishakhi
Published in
Journal of pharmaceutical sciences
Water-in-oil-in-water (w/o/w) double emulsions have shown excellent capability in augmenting the enteral bioavailability of BCS class III drugs, besides being effective controlled-release formulations. However, the problem of thermodynamic instability has restrained their industrial applicability. The self-double emulsifying drug delivery system (S...
Sreenivasan, Shravan Patil, Sanjeet S Rathore, Anurag S
Published in
Journal of pharmaceutical sciences
Therapeutic proteins such as monoclonal antibodies (mAb) are known to form aggregates due to various factors. Phosphate buffered saline (PBS), human serum, and human serum filtrate (HSF) are some of the models used to analyze mAb stability in physiologically relevant in-vitro conditions. In this study, aggregation of mAb in PBS and models derived f...
