2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.
News|Articles|May 15, 2019
- Pharmaceutical Technology-05-15-2019
- Volume 2019 eBook
- Issue 1
A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations
Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.
Advertisement
Silicone oil has been widely used to coat the components of container/closure systems for biopharmaceutical products, including syringe barrels and plungers for prefilled syringes and stoppers for glass vials. Drug product formulations are therefore typically in direct contact with the silicone oil coating over long periods of time, causing concern that the silicone oil may leach into the formulations, which may affect the drug product’s purity and efficacy.
Article Details
Pharmaceutical Technology
eBook: Biologics and Sterile Drug Manufacturing 2019
May 2019
Pages: 20–29
Citation
When referring to this article, please cite it as X. Yu et al., "A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations," Pharmaceutical Technology Biologics and Sterile Drug Manufacturing eBook (May 2019).
Articles in this issue
over 7 years ago
Supply Chain Challenges for Single-Use Systemsover 7 years ago
Challenges with Successful Commercialization of Biosimilarsover 7 years ago
Test Methods and Quality Control for Prefilled Syringesover 7 years ago
Unknown and Unknowableover 7 years ago
Distinguishing Between Cleanroom Classification and MonitoringAdvertisement
Related to this article
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
The FDA Finalizes Rule Recognizing Non-Animal Testing Methods, Building on Year-Long Reduction Push
2
PharmTech AI Pulse Check: Validating Multi-Agent Systems, OCR Models in GxP
3
CPHI Milan: USP Benchmarks Reshape Procurement Incentives
4
Pharma Fundamentals: Digital Pathology in Drug Development, Part 1
5