Pharma

From its foundation KYMOS and PHARMAPROGRESS were 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. We are 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, we have the experience to advise you in any step and provide you a first class analytical and scientific support.

CMC

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

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The release of a biosimilar product into the market is extremely challanging. By one hand only a very well equiped laboratory may have the cappabilities to afford such activity, ensuring purity, identity, and potency. By the other hand GMP certificate and manufacturing authorization should be available at testing site, which is subject to periodic inspection of regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

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. An extensive analytical characterization based on an ortogonal approach is a key element for the project success. We can afford complex characterization projects of innovative biologics or biosimilars comparison.

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.

We have a wide experience in 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 should be used, we perform the method development and validation from scratch or the method transfer 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 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-equiped laboratory is available including a cleanroom with airlock tecnology and HEPA filters for the most sensitive operations. A 4 gloves isolator ISOFLEX-S is equiped 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.

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 European Pharmacopoeia and USP General Chapters <232>, <233> and <2232> for drug substances, excipients and drug products, including the 24 elements related in the ICH Q3D guideline and/or others.

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

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

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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 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: