Impact of residual impurities and contaminants on protein stability

W Wang, AA Ignatius, SV Thakkar - Journal of pharmaceutical sciences, 2014 - Elsevier
Production of recombinant proteins generates a variety of process-related impurities. The
multistep manufacturing processes may introduce many potential contaminants into the final …

Extractables and leachables considerations for prefilled syringes

DR Jenke - Expert opinion on drug delivery, 2014 - Taylor & Francis
Introduction: Use of pre-filled syringes as both a packaging and delivery system for
pharmaceutical drug products is accelerating. Pre-filled syringes must meet the quality and …

The stabilization of biopharmaceuticals: current understanding and future perspectives

JG Song, SH Lee, HK Han - Journal of Pharmaceutical Investigation, 2017 - Springer
Proteins have many therapeutic advantages over small synthetic drugs in terms of their high
specificity and activity. Accordingly, the global biopharmaceutical market grows rapidly and …

Assessment of the effects of sterilization methods on protein drug stability by elucidating decomposition mechanism and material analysis

K Nakamura, H Kiminami, A Yamashita, Y Abe… - International Journal of …, 2015 - Elsevier
The effects of different sterilization methods on the stability of highly sensitive protein drugs
were assessed by elucidating mechanism involved in the process of protein decomposition …

[HTML][HTML] Ready-to-use prefillable syringes: Sterilisation effects on biopharmaceuticals

W Dierick, K Nakamura - ONdrugDelivery Magazine, 2016 - ondrugdelivery.com
Pharmaceutical industry growth is buoyed this year by the expectation that 12 new drugs are
forecast to reach blockbuster sales by 2020. Within this market, the biotech sector is a large …

[HTML][HTML] Using prefillable syringes for biopharmaceuticals—development & challenges

W Dierick, K Yoshino - OnDrug Deliv, 2015 - ondrugdelivery.com
USING PREFILLABLE SYRINGES FOR BIOPHARMACEUTICALS – DEVELOPMENT &
CHALLENGES - ONdrugDelivery OndrugDelivery CONNECTIVITY INJECTION PFS …

Application of formulation principles to stability issues encountered during processing, manufacturing, and storage of drug substance and drug product protein …

S Vitharana, JM Stillahn, DS Katayama… - Journal of …, 2023 - Elsevier
The field of formulation and stabilization of protein therapeutics has become rather
extensive. However, most of the focus has been on stabilization of the final drug product …

预装式注射器与药物相容性的研究进展

刘小慧, 印晖, 严方, 狄斌 - 中国药科大学学报, 2016 - cqvip.com
预装式注射器与药物相容性的研究进展-[维普官方网站]-www.cqvip.com-维普网 我的维普 购物车
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[PDF][PDF] Использование предварительно наполненных шприцев для биофармацевтики-развитие проблемы

В Деррик, К Йошино - Фармацевтические технологии и упаковка, 2015 - medbusiness.ru
Прогресс генной инженерии повлёк за собой изменения развития фармацевтики от
низкомолекулярных к биофармацевтическим препаратам. В десятке продаж лекарств в …