PerkinElmer

CMC Testing

The Chemistry, manufacturing, and control (CMC) testing of drug substances and drug products play a critical role guaranteeing the quality of the drug product entering clinical trials. Subsequently, the validated methods and technologies are transferred to Quality Control (QC) in commercial manufacturing.

All ingredients including the methods used during the manufacturing process must be included in the CMC section of both the Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) dossiers. The documents must show the acceptable limits and analytical methods used to assure the identity, strength, quality, and purity of the drug substance and drug product including enough information to support stability. Additional information is required for the drug product such as packaging procedures.

PerkinElmer enables Pharma partners in rapidly developing and commercializing new small and large molecular entities across various therapeutic areas via innovative technology solutions and services, paving the way to support CMC compliance by providing:

  • Proven analytical solutions and services that provide instrumentation and in-field support to alleviate methods development and validation challenges within the CMC workflow
  • Enhanced security software capabilities to meet 21 CFR Part 11 compliance requirements
  • Comprehensive services offering from instrument IQ/OQ through validated SOP’s resulting in a compliance package for regulatory

Drug Substance & Excipients

Production comes to a halt when impurities are identified above the threshold level and the drug substance must be re-evaluated, increasing cost of production and time to market.

Drug substance is the active pharmacological ingredient used in a finished pharmaceutical product and has a direct effect on both the treatment and prevention of disease. To ensure the purity, quality and safety of a drug substance, it is essential to perform analytical tests to identify if any impurities or adulterants exist.

Our advance analytical tools provide the data to mitigate compliance risk and guide your GMP standards compliance for the identification of incoming raw material testing, drug substance assay and excipient quality.

The suitability of drug substance for its intended use is defined by attributes such as identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.

Drug Product

Drug product or finished dosage form (tablet, capsule, injectables) contain a drug substance (API) and excipients. All drug products must be GMP compliant to be released for commercial use.

The suitability of a drug product for its intended use is defined by attributes such as the identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.

Our analytical instrumentation, microfluidics technology, informatics solutions, and service and support, provide pharmaceutical manufacturers confidence in the quality of their product and compliance in their process from beginning to end.

Control of Impurities

Regulatory bodies, such as the EMA and FDA, provide increasingly stringent guidelines around impurity limits, control of those impurities becomes exponentially critical during CMC testing. Implementing testing to control impurities is crucial on your path to compliance.

PerkinElmer provides the tools and processes you need to take control of impurities testing for both drug substances and drug products – providing the best technology for the identification and quantification of elemental impurities and the accurate measurement of residual solvents in accordance with strict regulatory guidelines.

The suitability of either a drug substance or drug product for its intended use is defined by attributes such as the identity, strength, and purity – which can be achieved by using instruments, consumables and services you can find from PerkinElmer.

Explore Our CMC Solutions

Cleaning Validation

Regulatory authorities expect pharmaceutical companies to have written standard operating procedures (SOPs) detailing the cleaning processes used for various pi ...

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Foreign Particle Material Identification

Foreign Particle Material Identification is a key step in the quality control of medicines and is used to identify contaminants in drug products which might aff ...

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Degradation Products

Drug manufacturers may be required to accelerate or force degradation of a product to demonstrate that it has gone through the stability indicating method. In s ...

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Stability Testing

Typically, both drug substance and drug product are tested in at least two different storage conditions: long term ambient storage temperature and accelerated c ...

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Drug Repurposing

Drug repurposing or drug repositioning is a well-known approach used by scientists to minimize the costs and mitigate risks associated with drug development pro ...

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Protein Characterization

Sample preparation and characterization of proteins for quality by design (QbD) studies are important parts of process development; however, these studies, incl ...

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Regulatory & Compliance

The increasingly complex regulatory environments have forced laboratories to adopt a new mindset to compliance and auditing… moving away from traditional instru ...

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GMP Radiosynthesis Services

PerkinElmer's experienced chemists will work with you, scientist to scientist, to design and prepare your radiochemical. You'll have access to PerkinElmer's ext ...

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Explore Our Instruments

General Automated Liquid Handling

In today’s fast-paced, high throughput research laboratories, automation of methods and assays has become a necessity. Escalating workloads, limited sample supp ...

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Atomic Spectroscopy Instruments

If you're looking for world-leading AA, ICP-OES, ICP-MS, or mercury analysis systems, you've come to the right place. Tens of thousands of installations worldwi ...

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Molecular Spectroscopy Instruments

Characterize advanced complex materials on any budget. Our comprehensive portfolio of analytical solutions has the ideal molecular spectroscopy instruments for ...

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Thermal Analysis Instruments

Improve accuracy, sensitivity, and performance in thermal analysis using our comprehensive portfolio of instruments. Applications of our industry-leading techno ...

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EnVision Multimode Plate Reader

The EnVision® 2105 multimode plate reader provides exceptional speed, ultra-high throughput, and maximum sensitivity across all detection technologies. Tried an ...

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