Services

CMC

Chemistry, manufacturing and control analytical services are conducted under GMP compliance. During development, some phases may be executed according to GLP at the Client's request.

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Releasing a biosimilar product to market is extremely challenging. On the one hand, only a very well-equipped laboratory has the cappabilities to conduct this activity, ensuring purity, identity, and potency. On the other hand, the testing site should be GMP certified and have manufacturing authorization, subject to periodic inspections by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Working with biologic drugs involves a huge analytical effort to understand the characteristics of the whole molecule in depth. Various methods and technologies are requires to get the analytical fingerprint of the molecule. An extensive analytical characterization based on an orthogonal approach is a key element for the project's success. We offer complex characterization projects for innovative biologics and comparison of biosimilars.

Devices used for inhaled and nasal drug delivery are collectively referred to as Orally Inhaled and Nasal Drug Products (OINDPs). The range of products available is broad, encompassing inhalers (metered dose, dry powder and aqueous droplet), nebulizers (jet, ultrasonic and vibrating mesh) and nasal (aqueous based, dry powder and propellant based). Two of the main factors largely recognized as Critical Quality Attributes in the testing of OINDPs are the delivered dose and particle size distribution.

In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny from regulators. A study should be conducted to determine the profile of extractables in the container closure components that are in contact with the formulation during storage and/or use.

We have extensive experience performing analytical tests for APIsexcipientsintermediate productsfinished productspackaging materials and process environment samples. The most suitable method is used, according to customer specifications or the relevant Pharmacopoeias description (EP, USP, BP, JP). If non-compendial methods need to be used, we develop and validate the method from scratch or transfer the method from the manufacturer.

We have a comprehensive knowledge in the development and validation of analytical proprietary and non-proprietary methods for excipients, APIs, intermediate products and finished products, according to the ICH Q2 (R1) in line with Q6A and Q6B. Our methods are ready for transfer to contract-giver, in compliance with EU-GMP chapter 6, performing a comparative test, a co-validation in two sites or a revalidation.

We provide full CH studies and on-going stability programmes for third parties. These services, at the client's request, can include: method transfer, method improvement, analytical standards management, storage at different conditions, scheduling of analytical timepoints, full analysis and out-of-trend (OOT) and out-of-specification (OOS) management. These tasks are always conducted according to procedures agreed upon with the client.

We provide microbiological testing for sterile and non-sterile APIs and drug products. Our fully-equipped laboratory includes a cleanroom with airlock technology and HEPA filters for the most sensitive operations. Our 4-glove isolator ISOFLEX-S is equipped with a Steritest pump and an H2O2 generator. The main advantage of using isolation technology for sterility testing is to ensure that no fals- positive results are obtained.

We provide microbiological testing for nutraceutical and cosmetic products. Our fully equipped laboratory includes a cleanroom with airlock technology and HEPA filters for the most sensitive operations. ISO methods are implemented and validated iat Kymos laboratories in order to provide quality control services for nutraceutical and cosmetics as quickly as possible.

Both laboratories, KYMOS and PHARMAPROGRESS are GMP certified and we have a partial manufacturer authorization for Quality Control purposes. We offer the following services:

  • APIs Certificate of Analysis according to the relevant Pharmacopoeias
  • Individual parameter determination to be included in your batch Certificate of Analysis
  • Full analysis of all parameters to issue a stand alone batch Certificate of Analysis
  • Batch Testing and Batch Release of clinical batches
  • Batch Testing and Batch Release of marketing batches
  • Importation into the EU of medicinal drug products (human, veterinary or investigational)

We provide Elemental Impurities testing using ICP-MS according to ICH Q3D and European Pharmacopoeia and USP General Chapters <232>, <233> and <2232> for drug substances, excipients and drug products, including the 24 elements listed in the ICH Q3D guideline and/or others.

We can support you in conducting potency assays of vaccines for quality control in order to substitute "in vivo" testing. We can develop and validate a new method from scratch or improve on pre-existing methods or commercial kits. We can transfer these methods to your lab or keep it in house to provide you routine quality control of batches under GMP.

Revised monographs in the European Pharmacopoeia on heparin sodium (0333) and heparin calcium (0332) are in force from January 1st, 2015. These monographs include chromogenic anti-factor IIa and anti-factor Xa assays. The USP monograph for heparin sodium had been updated previously.

We have implemented and validated these challenging assays according to the USP monograph and they are ready to be used for drug products and drug substances. However, personalized method adjustments are necessary on a case-by-case basis.

Cleaning validation is a significant GMP activity to prevent contamination of biopharmaceutical products by ensuring that the processing equipment is suitable for later manufacturing processes. Potential contaminants include residues of the active pharmaceutical ingredients or their related substances, and residues from the products used during the cleaning process such as solvents or detergents. This is particularly important for highly-sensitizing compounds such as antibiotics, hormones and cytotoxics and in the case of parenteral drug products.

Bioanalysis

Bioanalysis services are conducted under GLP and in compliance with GCP when clinical samples are involved. In the early stages, they may be executed as non-GLP but always in a GXP-like environment.

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In biological substances coming from preclinical and clinical studies, we have a long track record of developing and validating bioanalytical methods from scratch or working with transferred methods. Furthermore, we have a great capacity for processing samples. In order to quantify the plasma or serum levels of biologics for PK calculations, we mostly work with immunology methods such as ELISA, ECLA or RIA, but we also have experience in mass spectrometry of large molecules.

We develop new bioanalytical methods for immunogenicity studies of proteins and peptides following EMA and FDA guidelines on Immunogenicity of Therapeutic Proteins. Depending on the purpose and the stage of the research project, different studies must be conducted:

  • Determination of Binding Antibodies: screening, confirmatory and titration testing
  • Neutralizing Antibodies
  • Antibody Typology
  • Cellular Immune Response

Our expertise in cell biology enables us to implement, validate and perform cell-based assays (CBA) for several applications, including potency assays and neutralizing antibodies. We work with cells from primary cell lines, established cell lines obtained from client's cell banks and cultured at Kymos or with different kinds of cells, for example immortalized cells lines or commercial arrested cell lines.

We can develop and validate bioanalytical methods for innovative small molecules using mass spectrometry. We have the experience that comes from being the partner selected by several companies to develop of proprietary methods from project kick-off to market.

  • Research: in vitro and in vivo ADMET studies  
  • Early development: preliminary pharmacokinetics
  • Regulatory preclinical in different species: toxicokinetics, pharmacokinetics, pharmacodynamics
  • Phase I studies: pharmacokinetics, dose searching studies, single and repeated dose
  • Phase II to IV clinical studies: related biomarkers, interaction with concomitant medication and feed

We have a great capacity for processing samples, up to 10.000 per month.

We are experts in bioanalysis for bioequivalence studies in collaboration with the sponsor and/or the selected clinical phase centre. We have a long list of validated bioanalytical methods and when not available, we perform the method validation free of charge for our clients in a very short period of time. LIST OF VALIDATED METHODS.

Moreover, we are also a well-reputed service provider for comprehensive management of bioequivalence studies thanks to strategic alliances with reliable GCP-compliant clinical phase centres.

We provide services of pharmacokinetics calculations and statistics for bioanalytical data coming from preclinical and clinical studies.

  • Non-Compartmental Analysis (NCA)
  • Compartmental modelling using built-in models or self-generated ones
  • Bioequivalence (AUC, Tmax, Cmax)

We use the Phoenix WinNonlin® software that has been properly validated according to guidelines for IT system validation.

We validate methods and analyse sample for pharmacokineticsresidue-depletion studies and bioequivalence studies in animals. Comprehensive study management can be offered, in conjunction with Kymos’ strategic partners for animal housing and preclinical experimentation: ISOQUIMEN for pets and CLINOBS for livestock.

We have extensive experience in validating the most common drugs for animal health, such as antibiotics, anthelmintic and anti-inflammatory drugs. CLICK HERE TO DOWNLOAD THE LIST OF VALIDATED BIOANALYTICAL METHODS.

We conduct bioanalysis on the active ingredients in biological samples coming from clinical studies on nutraceuticals, medical devices or phytopharmaceuticals. Moreover, we offer the comprehensive management of such studies thanks to a strategic partner for clinical activities: Ethics Committee approval, recruiting, administration to volunteers, sample collection, bioanalysis and clinical report.

We offer you our experience in studies on Percutaneous Absorption for topical semisolid drug products using vertical diffusion cells (or Franz cells) according to the EMA Draft Guideline on Quality and equivalence of topical products. Both In Vitro Release Test and In Vitro Permeation Test are available using the Hanson difussion Phoenix instrument.