Capsugel's Bram Baert and Sandrine Picco argue that chasing zero nitrite in pharmaceutical excipients is often impractical and costly. They recommend setting scientifically justified, risk-based limits and consistently staying below them.
News|Articles|June 30, 2020
Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation
Author(s)Pharmaceutical Technology Editors
The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.
Sartorius Stedim Biotech has launched its CONFIDENCE virus clearance services, a new feasibility studies, design, and optimization consultancy, to provide validation support for viral clearance processes.
Through the service, Sartorius will now provide feasibility virus-spiking studies for purification technologies using, among others but not exclusively, minute virus of mice (MVM) or murine leukemia virus (MuLV). This expansion in the company’s services portfolio will be followed by the launch of good laboratory practices (GLP) virus clearance studies in the second quarter of 2021. Sartorius will use advanced chromatography technologies for all studies to remove residual protein and obtain highly purified virus stocks in high titers. The company aims to achieve and ensure robust and reliable results, Sartorius stated in a June 23, 2020 press release.
The results from Sartorius’ virus clearance service has an approximately six-week turnaround time compared to the industry’s current lead times, which can reach six months, Sartorius stated in its press release. The shorter turnaround time can contribute to an increase in the potential success of GLP study completion.
Viral contamination has been a major challenge to biologic development because it can result in significant delays as manufacturers work to remove viral contaminants during production. Before manufacturing begins, the viral clearance process must be validated to ensure patient safety and to comply with regulatory requirements.
Source: Sartorius Stedim Biotech
Related to this article
Boyang Wang, Immortal Dragons, explains how FDA’s Expedited IND Pilot and research partners could speed serial steps to first-in-human trials compared to China’s 818 Decree.
This article examines how modern automation platforms create the digital foundation required for Pharma 4.0 by integrating manufacturing systems, centralized data management, Industrial Internet of Things connectivity, electronic batch production records, and AI-driven analytics.
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Trending on Pharmaceutical Technology
1
Pritelivir Shifts Resistant Herpes Care from Intravenous to Oral
2
Q&A: Patient-Centric Drug Development Should Start at Product Definition
3
What the Olanzapine Depot Approval Means for CMC Teams
4
PharmTech Weekly Roundup—Oct. 8, 2026: CPHI Highlights
5