March 2014 Issue

March14

Host Cell Residual DNA Quantitation

SEQ

The use of biologically derived drugs, in which host cell lines are used to express biological product, has increased dramatically in recent years. This has created a need to quantify residual host cell DNA during manufacturing and in final products.

The removal of host cell impurities is a critical step in the purification of biopharmaceutical products. A major challenge is the accurate and sensitive quantitation of host cell DNA impurities in both the purification process and in drug substance samples.

  • Quantitate
    host cell residual DNA typically in under 5 hours with the resDNASEQ®
    Residual DNA Quantitation Assays for E. coli and Pichia
  • Recover high levels of DNA from complex matrices with the PrepSEQ® Residual DNA Sample Preparation Kit
  • Analyze results with AccuSEQ® Real-Time PCR Detection Software

To ensure product quality, the amount of residual DNA in a drug’s final dosage form must meet regulatory guidelines established by the World Health Organization (WHO), the European Pharmacopeia, the US Food and Drug Administration (FDA), and other regulatory agencies.

A host cell quantitation system should be designed with the sensitivity to meet or exceed regulatory requirements, while enabling high throughput and cost effectiveness to enable robust process clearance study design.

The Life Technologies resDNASEQ® Host Cell Residual DNA Quantitation Systems measure levels of residual DNA from common host cell lines used in the production of biopharmaceutical products. The systems offer:

  • High-sensitivity quantitation using proven real-time qPCR technology
  • Specificity for target host cell DNA; no cross-reactivity with unrelated DNA
  • Consistent performance across the expected range of DNA fragment sizes
  • Accurate, reliable, and reproducible results
  • Optimized sample preparation for quantitative recovery from complex matrices
  • Option to automate sample preparation
  • Broadest panel of assays for the most commonly used cell lines for Monoclonal Antibody, Vaccine, and Recombinant Protein Production – CHO, E.coli. Vero, MDCK, NS0, Human, Pichia pastoris, Yeast

Learn more about other products under SEQ rapid molecular methods by clicking below links:

Therapeutic Drug Monitoring – Anti-HIV Drugs in serum / plasma by Chromsystems

Chrom

Four different types of drugs can be used to treat an HIV infection : nucleoside (NRTIs) and non-nucleoside reverse transcriptase inhabitors (NNRTIs), protease inhabitors (PIs) and fusion inhabitors (FIs). In contrast to the NRTIs, the NNRTIs and PIs exhibit a strong dose-effect relationship. With regard to the strong side effects and high risk of developing virus resistance to these drugs, a very precise adjustment and strict control of the drug levels is essential for patients.

This Chromsystems reagents kit is designed for the fast and easy analysis of all currently prescribed protease inhabitors (Amprenavir, Atazanavir, Indinavir, Lopinavir, Nelfinavir with M8 metabolite, Ritonavir, Saquinavir and Tipranavir) as well as the non-nucleoside reverse transcriptase inhabitors Nevirapine and Efavirenz. The method employs a selective solid phase extraction step which removes potentially interfering co-medications. An optimised chromatographic separation on an isocratic HPLC system with UV detection allows an analytical run time of less than 30 min. The inclusion of tailormaid internal standard in the method assures high precision and safety in qualifying the analytes. Automated sample preparation is possible with the Gilson® ASPEC™, reducing possible contact with HIV infected specimens.

Visit Chromsystems website for more product range.

Vydac 150HC Peptide Media for Peptide Therapeutics manufacturing

Grace

There has been a growing trend towards peptides as therapeutic agents in recent years. This has been driven by the many inherent benefits peptides provide over small molecule drugs and recent developments that overcome past limitations in manufacturing and delivery of peptide therapeutics.

Recent advances in peptide synthesis technologies have enabled manufacturing of complex peptides on a very large scale. New formulation and delivery strategies have opened the possibilities of oral delivery of protein and peptide drugs.

The most powerful method for peptide purification is reversed phase chromatography. For industrial purification, important consideration and selection of particle size, pore size, and stationary phase in relation to the peptide can optimize purification. Efficient column packing and use of dynamic axial compression can further improve results.

To address the growing demand for effective peptide purification, Grace has developed the new Vydac® 150HC purification media. The new Vydac® 150HC media is highly effective at purifying many small to medium-sized peptides with greater loading capacity and improved productivity compared to competitive media.

  • 2-3X Greater Loading Capacity than Leading Material
  • Improved Resolution and Purity
  • Unique Selectivity
  • Developed Specifically for Process Scale Purification of Peptides
  • Intended for Small to Medium Sized Peptides
  • Supported for Regulatory Submission

Download Grace Chromatography Essentials catalogue

Daicel Immobilized Chiral Columns

Chiral

Daicel provides pharmaceutical and related industries with enantiomeric separation products and services. Daicel® chiral columns are meant for High Performance.

A Daicel chiral HPLC column has two remarkable performance characteristics that separate it from all others: wide selectivity and a truly dynamic loading capacity.

The combination of the two provides you with a powerful tool that is unique in the industry.

  • Excellent resolution of racemates- Daicel chiral columns represent the most effective means of analyzing chiral compounds and obtaining pure enantiomers, i.e., to levels of >99% enantiomeric excess.
  • Fast, easy method development- Samples
    often require no prior derivatization, and Daicel chiral columns can be
    used directly on standard HPLC or Supercritical Fluid Chromatography
    instrumentation.
  • Columns are durable and long lasting- Daicel chiral columns exhibit a dynamic loading capacity and have been in continual use by a large number of laboratories.
  • Smooth transition from laboratory to development, pilot plant and production-Daicel
    chiral columns offer the ability to scale up in a linear fashion,
    minimizing changes in methodology and operating conditions.

Recent product developments consist of immobilized CSP, CHIRALPAK® IA, IB, IC, ID, IE and IF. These allow use of a wider range of chromatographic solvents.

These immobilized CSPs allow the use of a highly extended range of solvents.

Immobilized columns are designed for solvent flexibility for the resolution of compounds with limited solubility, outstanding solvent tolerance and excellent separations of enantiomers.

  • High efficiency separation
  • Comatible with organic solvents which give higher sample solubility as mobile phase
  • More possibility for successful baseline separation
  • More simple work for sample separation

Learn more about Chiral columns

Vydac 150HC Peptide Media for Peptide Therapeutics
manufacturing