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Impurity and Contaminant testing

Thermo Fisher Scientific

Quickly evaluate and monitor your biopharmaceutical production process

Monitoring the quality, safety, and potency of your pharmaceutical product during manufacturing is important—and testing accuracy and time-to-results are critical. Our robust portfolio of Applied Biosystems SEQ analytical testing solutions employs rapid, highly sensitive molecular methods to efficiently detect impurities, identify contaminants, and quantify titer. Delivering same-day results, often in less than 5 hours, our analytical solutions can help meet regulatory compliance for characterization and lot release testing.

Residual Host Cell DNA Quantitation

Developed to meet the rigors of regulatory guidelines, the Applied Biosystems resDNASEQ Residual Host Cell DNA kit offers a complete sample-to-results solution, including a highly-characterized genomic DNA standard, for accurate validation of sensitivity and specificity. The kits are designed to detect fragmented and unfragmented DNA resulting in confident quantitation. resDNASEQ Quantitative kits portfolio:

CHO DNA kit | E. coli DNA kit | HEK293 DNA kit | Human DNA kit | MDCK DNA kit | NS0 DNA kit | Pichia pastoris DNA kit | Sf9/Baculovirus DNA kit | Vero DNA kit | E1A DNA Fragment Length kit

Mycoplasma Detection Testing

Rapid mycoplasma testing for lot-release and in-process testing – MycoSEQ Mycoplasma Detection System, an integrated, real-time PCR (qPCR) solution.

  • Method accepted by regulatory agencies for mycoplasma detection in a cGMP environment.
  • Requires no live mycoplasma for testing or process validation.
  • Total workflow solution, from sample prep to analysis with SAE compatible software.
  • Detection of all recommended species listed in European, US, and Japanese Pharmacopeias.
  • Supported throughout the validation process by our regulatory and field application specialists.

Rapid Microbial Identification

Used in top pharmaceutical companies worldwide, the Applied Biosystems MicroSEQ Rapid Microbial Identification System is ideal for environmental monitoring, contamination investigation, root cause analysis, raw materials testing, and microbial identification in small-molecule and biopharmaceutical manufacturing, and service laboratories. The MicroSEQ Rapid Microbial ID System combines the benefits of PCR and DNA sequencing technologies to enable highly accurate results.

  • Accurate and specific: phylogenetic approach, based on the sequencing of the 16S rRNA gene for bacteria or the D2 region of the large subunit ribosomal DNA for fungi, delivers high discrimination power.
  • Regulatory compliant: complies with approaches recommended by regulatory agencies such as ICH, USP, EUP, and JP, for accurate contamination identification.
  • Rapid time to results: ~5 hrs from colony to identification, allowing in-process testing.
  • Wide range of organisms: software using largest and most comprehensive validated libraries for bacteria and fungi.
  • Streamlined workflow: standardized, simple and easy-to-validate workflow.
  • Support network: worldwide technical and validation support, detailed training and implementation guidance.

SteriSEQ Rapid Sterility Testing Assays

  • Fast—Delivers actionable results in less than 5 hours, enabling rapid contamination detection of in-process and raw materials, helping expedite the release of your cell therapy product
  • Sensitive—Detects bacterial and fungal species at 5-25 genome copies per reaction
  • Specific—Designed specifically for bacteria (16S rRNA) and fungi (18S rRNA), with no known cross-reactivity to in-process byproducts or sample matrix effects
  • Efficient—Minimizes use of sample material by simultaneously testing for bacteria and fungi, preserving precious cells for final product
  • Accurate—Discriminatory positive control helps eliminate false positives and an internal positive control helps ensure PCR reaction consistency in the samples

Lentiviral Vector Titer Determination

The Lentivirus Physical Titer Kit measures genome-containing lentiviral particles by RT-qPCR, and the Lentivirus Proviral DNA Titer Kit quantifies integrated proviral DNA in transduced cells for infectious titer and vector copy number assessment. These kits provide a convenient method to quantitate and correlate total and infectious LV particles, facilitating analytics in process development, optimization, and manufacturing QC.

ViralSEQ Lentivirus Physical and Proviral Titer kits now available for digital PCR.

Adventitious Virus Testing

Sf-rhabdovirus, Mouse Minute Virus (MMV) and Vesivirus are all viral contaminants that are potential threats to drug development manufacturing processes, in gene therapy and vaccine production. Get the reproducible accuracy and rapid results for risk mitigation or accelerated lot disposition with the ViralSEQ Real-Time PCR System that is part of a total workflow solution designed to lessen your bioproduction testing challenges in a GMP environment.