Holistic extractables and leachables program: evaluations of prefilled syringe systems for biotechnology products

M Ronk, J Liu, A Gallegos, Y Luo… - PDA Journal of …, 2020 - journal.pda.org
Prefilled syringes (PFS) are a container and delivery device of choice for storing and
administering therapeutic protein products to patients. Addressing concerns and regulatory …

Development of biotechnology products in pre-filled syringes: technical considerations and approaches

A Badkar, A Wolf, L Bohack, P Kolhe - Aaps Pharmscitech, 2011 - Springer
A monoclonal antibody (mAb) product development case study is presented to address
some of the issues faced during developing a pre-filled syringe (PFS) product for a …

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 …

Development of prefilled syringe combination products for biologics

MN Dimitrova, JS Bee, L Lu, JE Fernandez - Challenges in Protein Product …, 2018 - Springer
Biologics for treatment of a growing number acute and chronic conditions are often
developed as parenteral injectables. Prefilled syringes (PFS) and other combination …

Creating a holistic extractables and leachables (E&L) program for biotechnology products

K Li, G Rogers, Y Nashed-Samuel, H Lee… - PDA Journal of …, 2015 - journal.pda.org
The risk mitigation of extractables and leachables presents significant challenges to
regulators and drug manufacturers with respect to the development, as well as the lifecycle …

[PDF][PDF] Prefilled syringes for biopharmaceuticals

R Swift - Formulation and Process Development Strategies for …, 2010 - ndl.ethernet.edu.et
Traditionally, the most widely used container or closure system for biopharmaceuticals has
been a glass vial, closed with an elastomeric stopper and secured by a crimped aluminum …

Recommendation of single time point leachables testing for lyophilized biotechnology products stored in rubber stoppered glass vial systems

A Gallegos, J Liu, M Ronk, L Qi, K Li, D Semin… - Journal of …, 2022 - Elsevier
As a popular format of primary container closure systems, rubber stoppered glass vials are
often used in storing and delivering lyophilized and liquid formulated therapeutic protein …

On developing a process for conducting extractable–leachable assessment of components used for storage of biopharmaceuticals

AA Wakankar, YJ Wang, E Canova‐Davis, S Ma… - Journal of …, 2010 - Elsevier
Extractables and leachables are product‐related impurities that result from product contact
with components such as gaskets, stoppers, storage bags, cartridges, and prefilled syringes …

[PDF][PDF] Parenteral packaging concerns for biotech drugs

FL DeGrazio - BioProcess Int, 2006 - eu-assets.contentstack.com
Despite significant effort and research in delivering peptides and proteins through means
such as inhalation, transdermal injection, and direct contact with mucous membranes …

Development of syringes and vials for delivery of biologics: current challenges and innovative solutions

S Yoneda, T Torisu, S Uchiyama - Expert Opinion on Drug Delivery, 2021 - Taylor & Francis
Introduction Several new biopharmaceutical dosage forms have developed over time, such
as lyophilized vial, liquid vial, and liquid prefilled syringe formulations. This review …