The PharmTech team focused on its coverage of AAPS PharmSci 360 this week, conducting interviews with experts on a range of topics including formulation platforms, AI, amorphous solid dispersions, and animal studies.
|Articles|February 2, 2023
- Pharmaceutical Technology, February 2023
- Volume 47
- Issue 2
- Pages: 12
Biologics-Specific qPCR Workflows
Author(s)Pharmaceutical Technology Editors
Thermo Fisher Scientific’s QualTrak is tailored for biologics development.
Thermo Fisher Scientific’s QualTrak is a comprehensive suite of quantitative polymerase chain reaction (qPCR) tools that includes various Applied Biosystems solutions. The product is tailored for biologics development, including monoclonal antibodies, cell and gene therapies, and vaccines.
Among the solutions in QualTrak are the QuantStudio 6 and 7 Pro-Real Time PCR Systems, as well as the TaqMan and TaqPath master mixes and assays. The TaqPath BactoPure master mix is designed to detect as low as one copy of DNA per microliter from bacterial, viral, fungal, and mammalian sources to ensure contamination-free drug product and accurate titers.
QualTrak comes with readily available compliance documentation to reduce the time needed to comply with internal quality systems and regulatory requirements. To support post-discovery steps, such as manufacturing quality control and biodistribution, all master mixes and assays are manufactured at an ISO 13485-certified, FDA registered facility that uses current good manufacturing practices.
Articles in this issue
over 3 years ago
Combatting Future Viral Threats with Vaccine Advancesover 3 years ago
Convergence in the Global Regulatory Villageover 3 years ago
Supplementary Handwashing Techniques to Improve Hand Hygieneover 3 years ago
The Punctuated Evolution of Computer Software Validationover 3 years ago
Advantageous Positioning for Europe in Pharmaceutical Cannabisover 3 years ago
Harmonizing Rules Governing SPCs for Medicinal Productsover 3 years ago
Improving Gender Diversityover 3 years ago
FDA Interactions with Industry Under ScrutinyRelated to this article
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
The agreement between CDER and OII with allow for coordinated marketing application assessments and inspections.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
Shubhajit Paul, a senior research fellow in Boehringer Ingelheim’s Department of Material Analytical Sciences, spoke with PharmTech at AAPS PharmSci 360 to explain how tabletability prediction can be improved for roller-compacted formulations.