Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
|Articles|May 2, 2020
- Pharmaceutical Technology-05-02-2020
- Volume 44
- Issue 5
Pre-Packed Columns
Tosoh Bioscience introduced the SkillPak 1 mL and 5 mL pre-packed columns for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins, and viruses.
Tosoh Bioscience introduced the SkillPak 1 mL and 5 mL pre-packed columns for fast method development and resin screening of monoclonal antibodies, antibody constructs, oligonucleotides, proteins, and viruses.
The columns come pre-packed with Toyopearl, TSKgel, or Ca++Pure-HA process chromatography media and are ready for use immediately. Additionally, the high performance, scalable columns are available with short delivery times in affinity, anion and cation exchange, hydrophobic interaction, and size exclusion chromatographic modes. Peak performance is guaranteed, according to the company, and the columns can be operated directly with low- or medium-pressure liquid chromatography systems.
Articles in this issue
over 6 years ago
Modern Drug Manufacturing Key to COVID-19 Responseover 6 years ago
How Fast Is Too Fast?over 6 years ago
Starting a Career in the Bio/Pharmaceutical Industryover 6 years ago
Can We Teach an Old Drug New Tricks?over 6 years ago
Good Manufacturing Practices: Aseptic and Sterile Processingover 6 years ago
Small-Volume Conversion Kit for Bathless Dissolution Testersover 6 years ago
Inline High Shear Mixersover 6 years ago
Laser-Marked Smart ContainersRelated to this article
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.
Andrew Parker, PhD, executive drug development consultant, Quotient Sciences, explains how AI is integrated into pharmaceutical development.
PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
FDA opens applications for its Expedited IND Pilot, pairing sponsors with qualified research institutions to test rolling CMC review ahead of first-in-human trials.
2026 approvals, clinical data, and licensing deals are advancing subcutaneous biologics, reducing patient burden, and reshaping biopharma drug strategy.