Services

CMC

Chemistry, Manufacturing & Control analytical services are executed under GMP compliance. During development phases may be executed under GLP if it is a Client's requirement.

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The 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 (metereddose, dry powder and aqueous droplet), nebulisers (jet, ultrasonic and vibrating mesh) and nasal (aqueous based, dry powder and propellant based). Two of the main factors largely recognised as Critical Quality Attributes in the testing of OINDPs are delivered dose and particle size.

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 by the regulators. A study should be conducted to determine the extractables profile from the container closure components that are in contact with the formulation during storage and/or use.

Working with biologic drugs represents a huge analytical effort to deeply understand the whole molecule characteristics. Different methods and technologies are needed to get the analytical fingerprint. We can afford complex characterization projects of innovative biologics or biosimilars comparison. Our experience covers a range of biologics such as:

  • Hormones and toxins
  • Biosimilars (proteins and monoclonal antibodies)
  • Innovative proteins or innovative monoclonal antibodies
  • Antibody drug conjugates
  • Therapeutic peptides: innovative, generic and hybrid formulations
  • Polysaccharides: heparin and others
  • Non-living vaccines

We have wide experience in performing analytical tests of raw materials, APIs, intermediate products, finished products, packaging 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 should be used, We perform the method development and validation from scratch or the method transfer from the manufacturer. However, if compendial methods should be employed, a suitability test or a partial validation can be acceptable.

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) and FDA guidelines and using QbD strategies to improve the results. 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 service of ICH and on-going stability programs for third parties. The services, at client's choice, 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 performed according to procedures agreed with the client.

We provide microbiological testing for sterile and non-sterile APIs and drug products. A fully-equipped laboratory is available including a cleanroom with airlock technology and HEPA filters for the most sensitive operations. A 4 gloves isolator ISOFLEX-S is equipped with a Steritest pump and a H2O2 generator. The main advantage of using isolation technology for sterility testing is to assure that non-false positive results are obtained.

We provide microbiological testing for nutraceutical and cosmetic products. A fully-equipped laboratory is available including a cleanroom with airlock technology and HEPA filters for the most sensitive operations. ISO methods are implemented and validated in Kymos laboratories in order to provide quality control services for nutraceutical and cosmetics in the shortest times.

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 services of Elemental Impurities Analysis by ICP/MS according to ICH Q3D and USP General Chapters <232>, <233> and <2232>  for drug substances, excipients and drug products. We also assess on the extension of the risk analysis required in order to minimize the analytical workload.

We have a deep knowledge of spectrometry techniques such as NIR (Near Infrared) and RAMAN. Thanks to this background we have developed consultancy services to help companies to implement QbD for process development and PAT strategies for quality control and in-process control. The most extended objectives are:

  • Use of NIR & RAMAN for identification of raw materials
  • Use of NIR & RAMAN for in-process control
  • Implementation of Process Ananlytical Technology (PAT) strategy oriented to parametric real time batch release
  • Use of NIR for quantitative analysis of drug products

We may suport you in the development of potency assay of vaccines for quality control in order to substitute "in vivo" testing. We are able to perform the development and validation of a new method from scratch or improving previous 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 assays of anti-factor IIa and anti-factor Xa activities. USP monograph for Heparin sodium had been previously updated.

We have implemented and validated these challenging assays according to USP monograph and are ready to be used for drug product and drug substance. However, personalized method adjustments are necessary in a case by case basis.

Cleaning validation is a relevant GMP activity to prevent contamination of biopharmaceutical products by ensuring that the processing equipment is suitable for following 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 particullary important for highly-sensitizing compounds such as antibiotics, hormones and cytotoxics and in the case of parenteral drug products.

Bioanalysis

Bionalysis services are executed under GLP and in compliance with GCP when clinical samples are involved. In early phases 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 in development and validation of bioanalytical methods from scratch or working with transferred methods. In addition we have a high capacity of sample processing. For the determination of 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 should be performed:

  • Determination of Binding Antibodies: screening, confirmatory and titration
  • 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 like potency assays or neutralizing antibodies. We work with cells from primary cell lines, established cell lines obtained from cell banks of the clients and cultured at Kymos or with different kind of cells, for example immortalized cells lines or commercial arrested cell lines.

We offer bioanalytical method development and validation of innovative small molecules by mass spectrometry. We have the experience of being the selected partner for different companies for the development of proprietary methods from the start-up of a project to the market.

  • research: in vitro and in vivo ADMET studies  
  • early development: preliminar pharmacokinetics
  • regulatory preclinical in different species: toxicokinetics, phramacokinetics, 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 high capacity of sample processing 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 center. 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 the full management of bioequivalence studies thanks to strategic alliances with reliable GCP compliance clinical phase centers.

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

  • Non-Compartmental Analysis (NCA)
  • Compartmental modeling 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 offer method validation and sample analysis of pharmacokineticsresidue depletion studies and bioequivalence studies in animals. Full studies management can be performed with Kymos’ strategic partners for animal housing and preclinical experimentation: ISOQUIMEN for pets and CLINOBS for livestock.

We have wide experience in the development of the more common drugs in animal health, such as antibiotics, antihelmintics and antinflamatory drugs. CLICK HERE TO DOWNLOAD THE LIST OF VALIDATED BIOANALYTICAL METHODS.

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

We offer you our experience in studies of Percutaneous Absorption for topical semisolid drug products using vertical diffusion cells (o Franz cells) according to Chapter <725> of the Pharmacopeial Forum. Both In Vitro Release Test and In Vitro Permeation Test are offered: