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Envigo, Chemistry, Manufacture and Control (CMC)

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About Envigo, Chemistry, Manufacture and Control (CMC)

Divison of: Envigo

After you have developed your compound and your process, you need to keep control of the integrity of your work. Envigo has more than 20 years of experience in chemistry, manufacturing and control (CMC). Our customers can depend on the quality of our dedicated q-PCR facilities, our expert in vivo bioassay... Show more »

After you have developed your compound and your process, you need to keep control of the integrity of your work. Envigo has more than 20 years of experience in chemistry, manufacturing and control (CMC). Our customers can depend on the quality of our dedicated q-PCR facilities, our expert in vivo bioassay group, next generation impactor expertise, ICH compliant environmental stability suite and on-site QP services.

Biopharmaceutical analysis including q-PCR
Vaccines
Monoclonal antibodies
Peptides and proteins
Gene therapy
Specialized inhalation performance testing
Batch release and testing
Stability testing
Microbiology
Stress testing
Method transfer
Pharmacopeia testing
Method development/validation

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Certifications & Qualifications

cGMP GMP

Our Services (22)


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Regulatory Affairs Services

Price on request

Envigo’s CMC services division can operate both to non-GxP and cGMP. We satisfy all international regulatory requirements, and work to relevant cGMP, ICH, FDA and EU guidelines.

For CMC these include:
+ ICH Q1A (R2) stability testing of new drug substances and products
+ ICH Q6B specifications: Test procedures and acceptance... Show more »

Envigo’s CMC services division can operate both to non-GxP and cGMP. We satisfy all international regulatory requirements, and work to relevant cGMP, ICH, FDA and EU guidelines.

For CMC these include:
+ ICH Q1A (R2) stability testing of new drug substances and products
+ ICH Q6B specifications: Test procedures and acceptance criteria for biotechnological/biological products
+ ICH Q5C stability testing of biotechnological/biological products

For clients who wish to follow the quality by design (QbD) approach to product and process development, we work to the guidelines outlined in:
+ ICH Q8 (R2) pharmaceutical development
+ ICH Q9 quality risk management
+ ICH Q10 pharmaceutical quality system

For pre-clinical safety these include:
+ ICH M3 (R2) nonclinical safety studies
+ ICH S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals

All cGxP studies are conducted under the auspices of Envigo’s GxP quality assurance groups to ensure regulatory compliance.

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Forced Degradation Studies

Price on request

During the drug discovery or pre-clinical phases, real time stability data is generally unavailable, therefore in order to gain some understanding of drug substance/drug product stability it is necessary to perform forced degradation (aka stress testing).

These studies involve exposing the drug substance/drug
product to severe... Show more »

During the drug discovery or pre-clinical phases, real time stability data is generally unavailable, therefore in order to gain some understanding of drug substance/drug product stability it is necessary to perform forced degradation (aka stress testing).

These studies involve exposing the drug substance/drug
product to severe conditions in order to accelerate any degradation reactions which normally include:
+ Thermal denaturation
+ Humidity
+ pH acid/base
+ Ionic strength
+ Freeze/thaw
+ Oxidation
+ Light
+ Mechanical shear

The in-use study is a short term study that is intended to demonstrate the stability of the drug product for its use in the clinic setting during the administration to patients. Although several of the stability studies can be carried out for R&D purposes, the formal real-time and accelerated studies are performed under GMP with qualified or validated analytical methods.

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Product Stability Testing

Price on request

An essential component of any development program is stability, requiring a range of stability studies to demonstrate that the biopharmaceutical remains intact and potent during storage. The importance of such studies is highlighted in a set of regulatory guidance documents ICH Q1A(R2) Stability testing of new drug substances and... Show more »

An essential component of any development program is stability, requiring a range of stability studies to demonstrate that the biopharmaceutical remains intact and potent during storage. The importance of such studies is highlighted in a set of regulatory guidance documents ICH Q1A(R2) Stability testing of new drug substances and products, ICH Q1B Photostability testing of new drug substances and products and ICH Q5C Stability of biotechnology/biological products.

There are four types of stability study available for evaluating a biopharmaceutical:
+ Real time stability study
+ Accelerated stability study
+ Forced degradation stability study
+ In use stability studies

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Batch Release Testing

Price on request

A crucial component of any cGMP manufacture is the QC release testing of the batch/lot. With each GMP batch or lot, specific critical quality attributes of the drug substance or drug product need to be demonstrated and are required to fall within an acceptance range outlined in a prescribed release specification. Attributes... Show more »

A crucial component of any cGMP manufacture is the QC release testing of the batch/lot. With each GMP batch or lot, specific critical quality attributes of the drug substance or drug product need to be demonstrated and are required to fall within an acceptance range outlined in a prescribed release specification. Attributes include
+ Appearance and description
+ Identity
+ Purity and impurities
+ Potency
+ Quantity
+ General/compendial tests

QC release testing is performed by trained QC analysts under the auspices of the Quality Assurance team to ensure GMP compliance.
QC release testing uses well-established physicochemical techniques,
such as:
+ Compendial assays
+ Liquid chromatography
+ Electrophoretic chromatography
+ UV/visible spectroscopy
+ Biophysical analysis

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Analytical Method Validation

Price on request

Before an analytical method can be used in a cGMP setting it is necessary to show that it is fit-for-purpose. This is demonstrated by a phase appropriate validation assay, which is performed in line with the regulatory guidelines described in ICH Q2 (R1) Validation of analytical procedures: Text and Methodology.

Assay parameter... Show more »

Before an analytical method can be used in a cGMP setting it is necessary to show that it is fit-for-purpose. This is demonstrated by a phase appropriate validation assay, which is performed in line with the regulatory guidelines described in ICH Q2 (R1) Validation of analytical procedures: Text and Methodology.

Assay parameter qualification and validation tests available include:
+ Specificity
+ Linearity
+ Range
+ Accuracy
+ Precision
+ Repeatability
+ Intermediate precision
+ Detection limit
+ Quantitation limit
+ Robustness

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Analytical Method Development

Price on request

Envigo offers comprehensive, experienced method development (and method transfer) capabilities to support compliant bioanalysis of your product in development.

Together with our method validation capabilities, Envigo can develop analytical methods suitable for cGMP.

Envigo offers comprehensive, experienced method development (and method transfer) capabilities to support compliant bioanalysis of your product in development.

Together with our method validation capabilities, Envigo can develop analytical methods suitable for cGMP.

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Antibody Characterization

Price on request

Formulation development can range from the simple mixing of excipients with the drug substance to additional processing steps such as lyophilisation to produce a dry formulation.

Formulation development available includes the evaluation of a range of excipients and determining the effect upon the protein structure and stability... Show more »

Formulation development can range from the simple mixing of excipients with the drug substance to additional processing steps such as lyophilisation to produce a dry formulation.

Formulation development available includes the evaluation of a range of excipients and determining the effect upon the protein structure and stability profile using a series of physico-chemical analytical techniques.

Stress testing with a range of factors is generally applied to evaluate the effectiveness of the excipients and for optimisation purposes. Moreover, in the search for the formulation that provides the optimal stability and delivery characteristics, modern approaches to formulation development use DoE approaches in order to evaluate a wide range of excipients and physical conditions yet minimise the size of the studies to a manageable level.

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Protein Characterization

Price on request

Protein characterization involves analytical techniques that can determine the physicochemical properties of the biopharmaceutical as well as evaluating the primary structure and higher order structure (secondary/ tertiary and quaternary structure) of the protein. Protein characterization also involves determining product-related... Show more »

Protein characterization involves analytical techniques that can determine the physicochemical properties of the biopharmaceutical as well as evaluating the primary structure and higher order structure (secondary/ tertiary and quaternary structure) of the protein. Protein characterization also involves determining product-related impurities arising from spontaneous chemical reactions, enzymatic degradation or aggregation.

Listed below are some of the analytical techniques that can be used to provide protein characterization data. As no one analytical technique can provide a comprehensive understanding of a specific protein parameter, an approach using orthogonal techniques is usually required.

Primary structure/product-related impurities:
+ Mass spectrometry - intact mass/peptide mapping/N- & C-termini sequencing/ disulphide bonds/glycan analysis
+ SDS PAGE - molecular size and truncated forms
+ Isoelectric focusing - charged isoforms/deamidation
+ Reverse phase HPLC - hydrophobicity/hydrophilicity profile
+ Ion exchange chromatography - charged variant profile

Higher order structure/aggregation:
+ Circular dichroism - secondary and tertiary structural analysis
+ Intrinsic and extrinsic fluorescence - tertiary structural analysis
+ Differential scanning calorimetry - protein thermodynamics/tertiary structure
+ Isothermal titration calorimetry – thermodynamics of protein binding
+ Surface plasmon resonance - protein binding
+ SEC-MALLS - quaternary structure/aggregation
+ Dynamic light scattering – quaternary structure/ aggregation
+ Analytical ultracentrifuge – quaternary structure/ aggregation
+ Field flow fractionation – quaternary structure/ aggregation

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Biopharmaceutical Process Development

Price on request
Request a quote for more information about this service.

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Biopharmaceutical Characterization

Price on request

Once the biopharmaceutical(s) has been selected, it is essential to understand with some detail the mechanism of action of the protein in treating the disease state: there is increased focus on understanding the pathology of a specific disease, identifying and validating appropriate
biomarkers and providing more effective proof of... Show more »

Once the biopharmaceutical(s) has been selected, it is essential to understand with some detail the mechanism of action of the protein in treating the disease state: there is increased focus on understanding the pathology of a specific disease, identifying and validating appropriate
biomarkers and providing more effective proof of therapeutic concept, to increase the overall success rate.

Such studies can involve in vitro and/or in vivo analysis. Examples of such studies include:
+ Cell proliferation
+ Apoptosis/necrosis
+ Effector function
+ Receptor/ligand binding
+ Neutralisation
+ Cell signalling
+ Migration, transmigration
+ Microbial challenge

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Drug Preformulation

Price on request

During pre-formulation risk assessment, lead candidates are screened for conformational and colloidal stability as well as the potential for post-translational modifications (PTMs) that could perturb the structural integrity of the biopharmaceutical. Pre-formulation assessment is performed in the R&D drug discovery phase, prior to... Show more »

During pre-formulation risk assessment, lead candidates are screened for conformational and colloidal stability as well as the potential for post-translational modifications (PTMs) that could perturb the structural integrity of the biopharmaceutical. Pre-formulation assessment is performed in the R&D drug discovery phase, prior to pre-clinical development activities. The elements of a pre-formulation risk assessment are sequence analysis, conformational stability and colloidal stability.

Sequence analysis in silico assessment of potential degradative events:
+ Deamidation
+ Oxidation
+ Proteolytic hydrolysis sites

Conformational stability
+ Isoelectric point (pI)
+ Thermal stability (Tm)
+ Hydrophobicity/hydrophilicity (HIC)

Colloidal stability
+ Polyethyleneglycol (PEG) solubility
+ Diffusion interactive parameter (KD)
+ Viscosity at high concentration

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Feasibility Studies

Price on request

As a component of the QbD approach, developability risk assessment studies are designed to de-risk process development at a very early stage. These studies aim to assess the stability profile of a candidate biopharmaceutical, or rank the stability profiles of a series of similar biopharmaceuticals, from a manufacturing point of... Show more »

As a component of the QbD approach, developability risk assessment studies are designed to de-risk process development at a very early stage. These studies aim to assess the stability profile of a candidate biopharmaceutical, or rank the stability profiles of a series of similar biopharmaceuticals, from a manufacturing point of view, prior to formulation or process development.

Developability involves stressing the protein to determine intrinsic molecular stability. As a result, the biopharmaceutical is exposed to a range of stress conditions, which normally include:
+ Thermal denaturation
+ Humidity
+ pH acid/base
+ Ionic strength
+ Freeze/thaw
+ Oxidation
+ Light
+ Mechanical shear

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Chemistry, Manufacturing and Controls (CMC)

Price on request

Envigo’s CMC analytical activities spans the development cycle from initial R&D discovery studies through to QC batch release testing for clinical trials, and on to support commercial release.

We specialize in biologics ‘mode of action’ studies, characterization, stress testing, method development, technology transfer, and... Show more »

Envigo’s CMC analytical activities spans the development cycle from initial R&D discovery studies through to QC batch release testing for clinical trials, and on to support commercial release.

We specialize in biologics ‘mode of action’ studies, characterization, stress testing, method development, technology transfer, and validation.

Envigo offers a range of both non-cGMP and cGMP CMC biopharmaceutical development studies.

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Formulation Services

Price on request

Formulation Services

Formulation Services

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Biology

Price on request

Biology Services

Biology Services

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Biochemistry & Molecular Biology

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Biochemistry & Molecular Biology Services

Biochemistry & Molecular Biology Services

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Protein Services

Price on request

Protein Services

Protein Services

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Antibody Services

Price on request

Antibody Services

Antibody Services

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Chemistry and Materials

Price on request

Chemistry and Materials Services

Chemistry and Materials Services

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Analytical Chemistry Services

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Analytical Chemistry Services

Analytical Chemistry Services

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Physical Analysis Methods

Price on request

Physical Analysis Methods Services

Physical Analysis Methods Services

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Strength Analysis

Price on request

Strength Analysis Services

Strength Analysis Services

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