Services

 

FORMULATION AND PRODUCT DEVELOPMENT

Link the discovery phase to early development: analyse and interpret the biopharmaceutical profile of new and old drug entities, and design pre-formulation studies efficiently.

  • Identify prototype formulations for early pharmacokinetics and toxicity profiling.
  • Identify successful drug candidates
  • Determine the shortcomings of the drug entity and their impact on dosage form selection: most drug molecules suffer poor-solubility, poor absorption, chemical and physical instabilities.
  • Assessing the most relevant biopharmaceutical and physico-chemical properties of the drug substance
  • Provide directions on how to apply chemical modification strategies ( such as conjugation, pro-drug design), complexation, or delivery system technologies to enhance drug performance or to address specific biopharmaceutical issues

Identify and develop drug formulation and delivery strategies to improve biopharmaceutical performances of marketed drugs and support their lifecycle management.

  • Determine the shortcomings of drugs, define development strategies and identify the technology platforms available for developing a novel dosage form or modified molecule with improved biopharmaceutical properties
  • Identify and provide evaluation of non parenteral routes of administration for peptides and proteins; design suitable experimental programs to assess their potential

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ANALYTICAL METHODS DEVELOPMENT AND VALIDATION

Dissolution methods development for research, quality control and stability monitoring; where possible , prediction of in-vivo performance.

Development of stability-indicating analytical methods, including validation and verification protocols.

Accessible equipment and techniques include NMR, Mass Spectroscopy, LC-MS, Electroacoustic Spectroscopy, and more.

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STRATEGIC AND SCIENTIFIC SUPPORT TO STARTUP AND DEVELOPING COMPANIES

Scientific advise and operational support to R&D and Business Development units in developing their own formulation technologies , drug delivery platforms and pharmaceutical products.

Strategic evaluation of drug delivery technologies and positioning of internal technology platforms or products pipelines versus competition.

Scientific and technical support to due diligence operations; evaluation of novel formulations, drug delivery technology platforms and new product opportunities.

Support in the definition of requirements for different development phases for new drugs (Lead Candidate identification, Preclinical, Phase I), in planning and in management of projects related to such phases.

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DEVELOPMENT OF DISINFECTANTS FOR HOSPITAL USE

Support and manage experimental programs to develop disinfecting formulations for hospital use, to disinfect patients' skin prior and after surgery, or for the disinfection of surgical equipment.

  • Stabilization of the disinfecting formulation
  • Excipients selection and impact on formulation stability and efficacy
  • Compliance with current regulations
  • Patient compliance

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DOCUMENTATION AND COMPLIANCE

Preparation of reports and protocols to be included in formal submissions or applications for product certification.

Dossier review and expert reports for applications for Certification of Suitability of Monographs of the European Pharmacopoeia: TSE risk assessment and chemical purity.

Record auditing in preparation for formal inspections, according to cGMP and cGLP regulations.

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BIOINFORMATICS

A key factor for biotechnology research is the ability to process and extract useful information from the very big amount of data accumulated, activity that requires a considerable computing power.

The need to store, manage and process these data has come to the birth of Bioinformatics, as a discipline concerning the study, development and integration of informatic tools for the scientific research in the field of biotechnologies.

SiTec has established productive links with bioinformatics experts, and can facilitate direct contacts with such groups, ensuring that bioinformatics support can be provided to clients needing this expertise.

  • Computational biology
  • Cheminformatics
  • Data mining
  • Protein sequence analisys

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PROFESSIONAL TRAINING

Direct training of laboratory and scientific personnel, provided at BioIndustry Park and on-site at clients' facility.

SiTec is an authorized representative for the Center for Professional Advancement. The CfPA is a private educational institution dedicated to the provision of continuing technical and scientific education at a professional level.

In addition to organizing cfpa courses at the Bioindustry Park Client-site courses that maximize training effectiveness by customizing the program to Companies' specific needs or interest.

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