New chemical entities

Like the birth of a child, your new chemical entity (NCE) has any number of likely futures.  The potential is infinite, but with that limitless possibility comes questions – questions that need to be answered quickly, effectively, and reliably so that you can make more informed decisions.  At Envigo, we understand the value of the NCE to your portfolio and the need to make the best decision on further development of the compound.  Envigo’s decades of experience in pharmaceutical analytics ensures you have the expertise you need to make those decisions and a trusted partner who is fully committed to your success. 

 Envigo offers the following analytics services for your new chemical entity:

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Physiochemical analytical techniques are a critical step for your new chemical entity.  A wide range of physicochemical assays are required for release testing, stability testing, molecular characterization and comparability testing. While some guidance is provided by the regulators, the selection of appropriate analytical techniques is not prescriptive.  Regulatory requirements depend on an in depth understanding of analytical techniques and how these can be applied to pharmaceuticals. Turning to Envigo allows you to tap into our extensive experience delivering CMC cGMP analytical services for over 500 biopharmaceutical agents of various modalities providing such analyses as the following:

  • Compendial assay
  • Liquid chromatography
  • Electophoretic chromatography
  • UV/visible spectroscopy
  • Mass spectrometry 

In addition to physicochemical assays for the analysis of the NCE molecules, Envigo offers over 20 years of experience in the testing of NCE formulations such as:

  • Solid dosage forms – tablets, capsules (immediate and controlled release), gums
  • Liquid dosage forms – LVPs, SVPs, oral solutions and suspensions, ophthalmics, autoinjectors
  • Inhaled products – pMDIs, DPIs, nasal sprays

In vitro cell based assays offer a major alternative for potency determination in a CMC cGMP manufacturing setting.  If you are looking for a reliable potency assay, Envigo has a dedicated team and CMC cell culture facility to support you. Based on 75+ years of experience and a thorough understanding of cellular and molecular biology, our team has developed and applied cell based assays across numerous therapeutic modalities from early candidate selection through to commercial lot release testing.  

Envigo offers a full suite of assays including the following:

  • Cell proliferation and survival
  • Programmed cell death (PCD)
  • Cell surface binding
  • Binding
  • Competition
  • Neutralization
  • Cellular response
  • Signaling and reporter
  • Migration, transmigration
  • In vivo activity 

We can also provide the following assay readouts for your new chemical entity:

  • Fluorescence intensity and time-resolved fluorescence
  • Fluorescence polarization
  • Fluorescence resonance energy transfer
  • Absorbance
  • Luminescence
  • Flow cytometry
  • Gene expression by RT-qPCR

With NCEs the functionality of the molecule is linked to its ability to bind to a target molecule or receptor.  Consequently, ligand binding assays are an essential component of your release and stability testing program. To support you, Envigo has extensive experience in the development of reliable and robust cGMP ligand binding assays even if using them as a substitute for your potency bioassay.  Our scientists have successfully developed and operated dozens of LBAs for NCEs like yours, ranging from pre-clinical to marketed products.

Effective and optimized assay development is critical to demonstrating proof of concept for your NCE.  From
physicochemical analysis to ligand binding, your assay needs to operate in a cGMP setting, be fit-for-purpose, and be simplified through automation to increase robustness.  At Envigo, we combine one of the industry’s most comprehensive assay development services with diverse expertise in our team of scientists to give you reliable and rapid results.  Additionally, Envigo’s commitment to innovation has enabled us to include quality by design (QbD) and design of experiment (DoE) approaches to assay development so that you can reduce assay failure rates.

You have developed an analytical method and now need to seamlessly implement a technology transfer to the recipient laboratory in support of GMP manufacturing. At this critical stage, qualification or validation of the assay must ensure comparable data, reproducibility, and consistency. At Envigo, we give you the peace of mind that your technology transfer will be smooth regardless of analytical complexity. Envigo has transferred over 500 methods across 90 techniques in the past five years, including the following:

  • Process control/monitoring
  • Release and stability testing
  • Manufacturing process transfer and scale up

Before an analytical method can be used in a GMP setting it is necessary to show that it is fit-for-purpose.  But how do you decide whether to use qualification or validation methods?  Envigo is your ally. We are highly experienced in both qualifying and validating assays for GMP manufacture support.  With early phase assays we work with you to agree on the extent of qualification using a risk based approach. Once assay qualification is complete, Envigo can test the drug substance/product for clinical release and stability trials.  For later phase development, our team of lead scientists has vast experience in validation methods according to the ICH Q2 guidelines. Using this experience we create validation protocols with you to ensure that all assays are fit for purpose in the context in which they are used.  In the past five years, over 500 methods have been successfully validated and are being used in submissions for clinical release through to commercial release of products.

The critical quality attributes of your product need to be demonstrated and are required to fall into a very narrow range.  Recognizing that future GMP manufacture of the product will depend on QC release testing of the batch/lot, there is no room for error. Envigo is highly experienced in QC release testing having provided services for numerous biopharmaceuticals from phase I to commercial release.  Moreover, under the auspices of the GMP quality assurance team, Envigo is one of the few companies that can provide both physicochemical, compendial and potency/bioassay testing. 

Envigo’s QC release testing analytical methods enable you to address the following:

  • Appearance and description
  • Identity
  • Purity and impurities
  • Potency
  • Quantity
  • General/compendial tests

How stable is your product?  Can it remain intact and potent during storage?  To ensure the safety and efficacy of the product, Envigo helps you to determine shelf life and temperature effects on your GMP grade material. If your product is in early development, Envigo can also help you evaluate the intrinsic stability, determine degradation pathways, elucidate the structures of the degradative products and establish which analytical techniques are stability-indicating. 

Envigo can support any of the four types of stability study:

  • Real time stability study
  • Accelerated stability study
  • Forced degradation stability study
  • Photostability study 

Regulatory guidance for stability studies is provided by the following:

  • ICH Q1A(R2) Stability testing of new drug substances and products
  • ICH Q1B Photostability testing of new drug substances and products
  • ICH Q5C Stability of biotechnology/biological products 

Envigo is highly experienced in all forms of stability study, from formal GMP studies to R&D based forced degradation studies, and that expertise enables us to meet your unique study needs.   Our experienced stability scientists can design flexible, phase specific protocols to suit the intended purpose for the data and ensure it is fit for purpose. Additionally, Envigo operates a GMP compliant stability facility, including stability chambers set at all the recommended ICH accelerated conditions and standalone units that can be set to new temperatures and humidity, as required. The stability facility is operated under the auspices of the GMP quality assurance group.

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