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Biopharmaceutical Research & Development Services

IBI offers services for the development, testing and manufacturing of pharmaceutical products (API and/or finished products), guaranteeing optimum results in terms of quality and realization times. The goal can be both the development of products for clinical trials and the manufacture of test batches for obtaining a marketing authorization or the transfer of production to your own premises.

IBI’s CDM division offers technologically avant-garde services for the manufacture of biological molecules, such as recombinant proteins and monoclonal antibodies, for formulation development (including innovative delivery systems such as lipid and polymer nano- and microparticles) and for analytical development; with skill, experience and flexibility, it scales up robust and reliable production processes, amongst which bulk and/or vial freeze-drying processes.

In agreement with the most recent guidelines and the most modern development methods, the CDM division adopts “Quality by Design” to optimize the production processes, characterize the critical parameters and support the documentation produced for the presentation of dossiers to the regulatory authorities. This approach is implemented through the application of DOE techniques. The collected data is processed for statistics using specific software, and risk assessment is performed during the scaling up and industrialization of the processes developed in the lab.


BIOLOGICAL API PROCESS DEVELOPMENT
CHO cell line development
Up- and downstream development and scaling up
Analytical characterization of biological active ingredients

FORMULATION DEVELOPMENT
Development of different types of formulations (oral, topical and injectable) for the manufacture of finished products (also biotechnological molecules)
Innovative delivery systems development
Microfluidic systems for nanoparticle preparation
Avant-garde tools for studying freeze-drying processes
Experience in technological transfer and industrial scaling up of production processes

ANALYTICAL DEVELOPMENT
Definition and testing of new analytical methods for small molecules and biotechnological products
Method optimization and/or transfer
Stability studies in accordance with ICH guidelines

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Notice on the treatment of personal data

Dear visitor, in the following sections we will describe how the reserved area of the www.ibi-lorenzini.it website is managed as far as processing personal data of users. The notice is issued pursuant to art. 13 of EU Regulation 679/2016 (hereinafter also the Regulation) on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and applies to those who interact with the website of Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. (hereinafter I.B.I.), which can be accessed at the following address: www.ibi-lorenzini.it, the opening page of the official I.B.I. website. The notice only applies to the I.B.I. website. It does not apply to any other websites that the user may access through links.

  1. The processing of the personal data that you supply, which are also used for the creation of your user profile, and which will be included in the “Doctors’ Details” database, has the following purposes:

  • carry out medical sales related activities for drugs for human consumption. Istituto Biochimico Italiano Giovanni Lorenzini S.p.A. and Ibigen S.r.l., part of the same company group (hereinafter also Ibigen Group), carry out such activities in compliance with the provisions of the current regulations, with particular, but not exclusive, attention to Italian Legislative Decree no. 219 of 24.04.2006 and subsequent modifications. In view of the objectives of the Ibigen Group, it is important to point out that the processing activities do not deal with any special data. The supply of the data for the medical sales activities is necessary, and failure to provide consent will make it impossible for us to fulfil the above objectives;

  • forwarding of invitations or information on congresses, conferences, seminars, communications on initiatives promoted or sponsored by the Ibigen group, regular or occasional publications, information on new products, methods and services. Such activities are carried out by e-mail, fax, SMS, normal post or telephone. The supply of the data for such purposes is optional, and failure to supply them will result in the information not being forwarded.

  1. As far as the creation of your profile on our website, we remind you that your password is strictly confidential and should not be disclosed.
  2. Your data will not be disclosed, but may be shared with individuals, companies, associations or professional studios providing support or consultancy services to the Ibigen Group, the medical sales representative network, our suppliers and any sub-suppliers - from time to time entrusted with activities connected with the above objectives -, mailing or statistical survey companies, or companies for the forwarding of scientific documentation, and individuals authorised to access the data by law and/or pursuant to secondary regulations.
  3. Such people may only acquire knowledge of your personal data for the above mentioned purposes.
  4. The Owners of the Treatment (Data Controllers) are the two companies of the Ibigen Group with legal headquarters at Via Fossignano no. 2, Aprilia (LT), Italy.
  5. Personal data are processed using manual and automated means, for the time necessary for reaching the objectives for which they were collected. Special safety measures are in place to avoid data loss, unlawful or incorrect use and unauthorised access.
  6. Lastly, we also inform you that you can at any time exercise the rights contemplated by the Regulation, and in particular request access to the data, their correction, update and block, or you can withdraw your consent, or request the limitation of the processing or the cancellation of the data. As data subject, you also have the right to issue a complaint with the relevant control Authority. Such rights may be exercised in writing to the following e-mail address: info@ibi-lorenzini.com.
  7. The Data Protection Officer may be contacted at the following e-mail address: dpo_ibi@protectiontrade.it

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