Biological products, such as therapeutic proteins, monoclonal antibodies, vaccines, and cell and gene therapy products have become increasingly important. Unlike traditional chemically synthesized drugs that act on a hydrophobic pocket of a protein to activate or inhibit a kinase pathway, biotherapeutics pharmacological action is via binding to its target or immunomodulation.
Due to the complex nature of biological products, scientists encounter multiple challenges from early drug discovery through development. For example, during identification of a clone with the desired immunogenicity that can demonstrate binding specificity to the target and subsequent modulation or elicit the desired immune response, and further during clone characterization, scale-up, and production of these products.
From discovery through manufacturing, harnessing large molecule drugs to create safe and effective therapies is complex and expensive. PerkinElmer enables scientists to develop and streamline their entire biologics workflow so they can overcome these challenges and bring consistent, high-quality, biological medicines to market faster.
During the early stages of drug discovery, it is critical to understand the target biology, mechanism of action (MoA) using the most accurate instrumentation including automation, and software to simplify complex workflows from clone selection and expression to lead discovery and screening.
Accelerate your biomolecular discovery by using a combination of in vitro and in vivo techniques accoupled with powerful software transforming data into insights.
Comprehending the interactions between innate and adaptive immunity play a critical role in the research, discovery and the development of biological products.
Due to the complexity of the immune system and its mechanisms, scientists rely on the latest advancements in technology including immune functional assays to better understand the immune system.
Biological products characterization ensures stability of the drug across the entire process, in terms of the structure, specific activity against the target and maintenance of the functional attributes as defined by Critical Quality Attributes (CQA's) that must be met to comply with regulatory guidelines.
From early drug discovery characterization, scientists use developability approaches to mitigate risk in late drug development during Chemistry, Manufacturing and Control (CMC) testing by relying on analytical instrumentation including GxP compliance and instrument qualification to guarantee safe and effective drug products used in clinical trials and reduce time to market.
During early and late drug development a comprehensive set of studies are required to guarantee biological products are safe and effective, uncovering any potential risks to patients.
Preclinical development including small animal model testing is required to identify side effects such as immunotoxicity of the large molecule candidate on the immune system.
Strict regulations such as GLP, GMP and GCP are in place to minimize risks, guarantee safety and accelerate the process of a biological product approval.
When it comes to drug manufacturing we offer everything to stay compliant each step of the way, from our robust characterization technologies such as microfluidics and spectroscopy platforms to supporting the evaluation of viral therapeutics, including vaccines, repurposed drugs during the Chemistry Manufacturing and Controls (CMC) protocols and QA/QC batch release of commercially available medicines.