Results 1 to 10 of about 116,460 (141)

Selected Biological Medicinal Products and Their Veterinary Use [PDF]

Animals, 2020
Definitions of biological medicinal products (BMPs) vary depending on the source. BMPs are manufactured using complex biological/biotechnological processes involving living cell lines, tissues and organisms such as microorganisms, plants, humans and even
Aleksandra Zygmuntowicz, Artur Burmańczuk, Włodzimierz Markiewicz   +2 more
doaj   +4 more sources

Biological medicinal products: reference and biosimilar products – selected issues

Journal of Education, Health and Sport, 2021
Biological therapies are being used in many chronic conditions. Development of biosimilar medicines gives chances for wider access to biological treatment.
Bartosz Kobuszewski
doaj   +3 more sources

Challenges and Opportunities for the Traceability of (Biological) Medicinal Products. [PDF]

Drug Saf, 2018
This article provides an overview of the current situation regarding the traceability of medicinal products, with a focus on drug safety and biologics. Limited traceability of biologics, in particular with regard to the batch number, is associated with incomplete recording of exposure information in clinical practice. The current pharmaceutical barcode
Klein K, Stolk P.
europepmc   +4 more sources

SARS-CoV-2 and the safety margins of cell-based biological medicinal products. [PDF]

Biologicals, 2020
With the pandemic emergence of SARS-CoV-2, the exposure of cell substrates used for manufacturing of medicines has become a possibility. Cell lines used in biomanufacturing were thus evaluated for their SARS-CoV-2 susceptibility, and the detection of SARS-CoV-2 in culture supernatants by routine adventitious virus testing of fermenter harvest tested.
Modrof J, Kerschbaum A, Farcet MR, Niemeyer D, Corman VM, Kreil TR.   +5 more
europepmc   +4 more sources

European medicines agency guideline for biological medicinal products: a further step for a safe use of biosimilars. [PDF]

Clin Mol Allergy, 2015
Allergists and clinical immunologists welcome the recent revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins (“biosimilar”) that the European Medicines Agency (EMA) has published on December 18, 2014 [1].
Agostini C, Canonica GW, Maggi E.
europepmc   +5 more sources

Trypsin. Properties and Use in the Production of Biological Medicinal Products

Биопрепараты: Профилактика, диагностика, лечение, 2018
The production of biological medicinal products used for prophylactic, diagnostic and therapeutic purposes includes the use of inherently  variable biological processes and materials.
S. M. Sukhanova, E. M. Petruchuk, A. A. Generalov   +2 more
doaj   +3 more sources

Bee Products and Traditional Plant Therapies for Wound Care: a comprehensive review of scientific evidence and clinical applications [PDF]

Journal of Pharmacopuncture
Objectives: Natural substances with healing properties, especially medicinal plants and bee-derived products, have been integral to traditional medicine systems for centuries, contributing significantly to wound care.
Ahmed A. Rawwash, Emad Ahmed Fathy Hussein, Omar Mohammad Atta   +2 more
doaj   +2 more sources

Development, certification, and use of a pharmacopoeial standard for the content of immunoglobulin A in human immunoglobulins for parenteral administration

Биопрепараты: Профилактика, диагностика, лечение, 2023
Scientific relevance. The immunoglobulin A (IgA) impurity content in parenteral human immunoglobulins should be determined in accordance with the State Pharmacopoeia of the Russian Federation by kinetic nephelometry, radial immunodiffusion, or enzyme ...
A. V. Nechaev, E. Yu. Kudasheva, E. L. Postnova, R. A. Volkova, O. V. Fadeikina, I. V. Borisevich, A. A. Movsesyants   +6 more
doaj   +1 more source

Development of acceptance criteria for the results of anti-D IgG quantification in human anti-D (Rh_о) immunoglobulin preparations by enzyme immunoassay

Биопрепараты: Профилактика, диагностика, лечение, 2022
The competitive enzyme-linked immunosorbent assay (ELISA) used for the quantification of specific antibodies, anti-D (Rho) IgGs, in human anti-D (Rho) immunoglobulin preparations relies upon the competition between anti-D antibodies in the preparation ...
E. V. Shvedova, S. A. Leshina, E. Yu. Kudasheva, I. V. Borisevich, V. A. Merkulov, D. V. Shvedov   +5 more
doaj   +1 more source

Pragmatic rules for comparability of biological medicinal products [PDF]

Biologicals, 2020
Comparability is a key concept in the evaluation of both manufacturing changes and biosimilars. It constitutes a pragmatic and flexible approach which recognises that biologicals are inherently variable and that minor variations in quality attributes are often clinically irrelevant.
Plas, R.M. van der, Hoefnagel, Marcel H.N., Hillege, Hans L., Roes, K.C.B.   +3 more
openaire   +4 more sources