Pharmaceutical ingredients

 

Our company has been working for a lot of projects involving excipients and pharmaceutical active ingredients. A large number of the most known chemical multinationals are KYMOS' clients. We provide services of method development and validation, including stress testing and photostability when required, as well as ICH stability studies. Pharmaceutical ingredient manufacturers are facing a lot of analytical challenges due to the new requiremets regarding residual solvents, genotoxic impurities and elemental impurities. In addition microbiological testing is nowadays required not only for sterile ingredients but for non-sterile ones.

 

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 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

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 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: