Biologics Purity & Impurity Profile

Biologic must be eventually free of host cell proteins (HCP), nucleic acids and process related impurities such as cell culture media, detergents, and resin components. An understanding of the potential impurities and acceptable limits within the final product must be established.

In addition, for viral vector development such as Adeno-Associated Virus (AAV), viral capsid characterization is an important consideration to assess varying degrees of encapsidation – empty, partial, and full genome capsids. PerkinElmer's microfluidic technology, LabChip GX II platform can be leveraged to characterize capsids.

Elimination of contaminating agents is critical to the safety of the final drug product. Bacterial or fungal burdens need to be determined per guidelines from USP or EP. In addition to microbial testing, several in vitro and in vivo assays need to be performed to detect viruses.

We offer innovative solutions form nucleic acid analysis, protein characterization to AAV characterization helping streamline our impurity profile workflows and maintaining GMP compliance in both late drug discovery and later drug development stages.

Nucleic Acid Analysis and Protein Characterization

PerkinElmer offers automated microfluidic devices, simplifying the analysis of nucleic acid concentration and qualitative assessment of PCR products, and replacing the multiple manual steps of slab gel electrophoresis with high levels of accuracy.

Sample preparation and characterization of proteins for quality by design (QbD) studies are important parts of process development; however, these studies, including design of experiments(DoE), can be time-consuming, and sample analysis can easily exceed the capacity of most labs.

Miniaturization of small-scale protein purification provides greater process optimization with larger QbD and DoE studies allowing for parallel processing of samples for increased statistical significance and a greater breadth of variables within experimental shorter time frames.

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AAV Characterization

Adeno-associated virus (AAV) particles are one of the primary gene delivery vehicles used in clinical research because they facilitate long-term transgene expression in animal models with little associated toxicity and have low immunogenicity in humans. These particles could potentially be used to deliver protein receptors or nucleic acids to treat diseases caused by mutant genes. AAV particles belong to the parvovirus family and can only reproduce in vitro with the help of co-infection with other viruses. AAV consists of a protein shell encapsulating a 4.7 kb size genome containing the following genes and genetic material being administered:

  • Rep (replication)
  • Cap (capsid)
  • Assembly genes

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Residual Protein A, AlphaLISA Detection Kit

Protein A is a 42 kDa protein widely used in affinity chromatography to purify antibodies, most importantly antibody therapeutics. The native form of Protein A from S. Aureus, in addition to many modified recombinant Protein A variants, are used in chromatography. The strong affinity and the high selectivity of Protein A for antibodies lead to an effective removal of host cell proteins.

However, Protein A can be leached from columns to contaminate the antibody preparation. Since Protein A could elicit mitogenic or immunological reactions, there are strict regulations as to the acceptable levels of Protein A in antibody preparations. Therefore, there is a current need to quantitate Protein A in antibody preparations with excellent sensitivity and robustness, while maintaining high throughput capabilities.

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Host Cell Residual DNA AlphaLISA Detection Kit

Biologics can be impacted negatively by contamination with DNA introduced during fermentation and purification processes. While the use of serum-free media in the manufacturing process significantly improved the success rate on preventing DNA impurities, other routes of contamination, such as microbial contamination, remain a concern. It is thus critical to remove and monitor DNA impurities at each step in the purification process. This kit is designed to quantify the levels of DNA (from different hosts, either double- or single-stranded and of varying fragment sizes) in cell culture supernatants.

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Liquid Chromatography (HPLC & UHPLC)

The need for high performance and reliability are a given for QC labs performing assays to determine the strength and content of drug substances. Our proven, rugged, and reliable LC 300 system is the perfect choice when you need fast cycle times, reproducibility, and low carryover. With its elegant streamlined interface, the LC 300 range is easy to use and simplifies your day-to-day processes so you can focus on your applications.

Our analytical solutions, including a full suite of chromatography data system (CDS) software packages, consumables and service offerings, come together to deliver a total liquid chromatography solution to increase your throughput, reduce costs and limit unnecessary complexity in analytical processes.

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