Pharmaceutical ingredients

Our company has been working for a lot of projects involving excipients and pharmaceutical active ingredients. We are proud to count with the confidence of some of the bigest and most reputed API manufacturers of the world.

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

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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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 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

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 executed under GMP compliance. During development phases may be executed under GLP if it is a Client's requirement.

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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: