Pharma

 

From its foundation KYMOS is devoted to provide analytical services for pharmaceutical companies. The knowledge of the drug physicochemical properties and their interaction with the organism is indispensable to understand the process of absorption, distribution, metabolism, excretion and toxicity. So that the analysis is an essential activity in all phases of research, development and marketing of pharmaceutical products. KYMOS is focused in providing analytical support services in two different domains: bioanalysis and medicinal chemistry. Both activities have an important rol during the development.

A good bioanalytical method properly validated for each specie and biological matrix is necessary to correlate the toxicity of the drug during preclinical toxicokinetics and to characterise the pharmacokinetics and pharmacodinamics of the drug in the preclinical phase. Later on, during the clinical phase, other studies require a bioanalysis: dose searching, pK/pD, bioequivalence, toxicity, interaction, eficacy.

Medicinal chemistry is another activity that has to be started very soon in the development of a new drug. A standardization of the drug product is always one of the first activities to perform. When the synthetic route is stablished the profile of impurities gains importance, thus it may have an impact on toxicity. Stability properties have to be known in advance to avoid problems during the development. The validation of the tests is not always required and the extension of the analytcial testing depends on the stage of the development. In summary, KYMOS have the experience to advise you in any step and provide you a first class analytical and scientific support.

CMC

 
 

KYMOS has 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, KYMOS performs 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.

KYMOS has 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. KYMOS 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.

KYMOS provides 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-specification management. These tasks are always performed according to procedures agreed with the client.
 

KYMOS provides 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.

KYMOS is a certified GMP laboratory counting with 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)

KYMOS provides 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.

KYMOS has 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 PAT strategies in 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

KYMOS 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. Kymos has implemented and validated these challenging assays which can be applied to drug product and drug substance.

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.

KYMOS can assist you in the different steps of cleaning validation.

Bioanalysis

 
 

KYMOS offers 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

KYMOS has a high capacity of sample processing up to 10.000 per month.

KYMOS performs the bioanalysis of bioequivalence studies in collaboration with the sponsor and the selected clinical phase center. We have a long list of validated bioanalytical methods and if not, we perform the method validation free of charge for our clients in a very short period of time. LIST OF VALIDATED BIOANALYTICAL METHODS

Moreover, KYMOS is also a well-reputed service provider for whole bioequivalence studies thanks to strategic alliances with reliable GCP compliance clinical phase centers.

KYMOS offers 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)

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

KYMOS has implemented the 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: