IBSA Group

Production Sites

Following its establishment in 1945, IBSA Institut Biochimique SA launched an extraordinary development programme aimed at consolidating a global strategy of geographical expansion and developing company assets, which has made it a world market leader in certain specific therapeutic areas, whose products are sold in over 80 countries in 5 different continents.

The headquarters of the IBSA Institut Biochimique SA Group is located in Collina d’Oro just outside Lugano in Switzerland. The Group now consists of 15 companies, subsidiaries and branch offices in Europe, China and the United States, and boasts a vast product portfolio. We are the fourth largest company in the reproductive medicine sector behind the large multinationals and a world leader in the hyaluronic acid market.

Over the years, we have grown a great deal also outside Switzerland and our 2,032 resources are divided between the head office, the branch offices and manufacturing sites.

Each manufacturing site is dedicated to specific product ranges, in compliance with the separation of productive processes principle: a strategy that has made it possible to obtain certification by the most stringent regulatory authorities, as demonstrated by the recent approval of IBSA products in the United States.

 

 

The Lamone Plant in the Canton of Ticino, Switzerland

IBSA plant: Lamone

The Lamone plant produces gonadotropins and progesterone, hormones used in medically-assisted procreation (MAP) techniques. More specifically, the gonadotropins (FSH, hMG and hCG) are obtained from donor urine. As the medically-assisted procreation (MAP) area is a demanding challenge for the pharmaceutical sector, we have developed a dedicated plant and patented an exclusive human gonadotropin purification process.
The manufacturing process starts in China, with the collection of urine and the production of a processing intermediate known as “crude”. The final phases of the purification process take place at the Lamone plant, where the hormone range is produced in compliance with the highest purity and safety standards to preserve the integrity of the hormone’s glycoprotein structure. At the end of the purification process the hormone is freeze-dried and packaged.
We have developed an innovative technology that aims to improve local tolerability
to make the progesterone water-soluble and suitable for delivery by subcutaneous injection.

The Lamone site, where all this takes place, occupies a total surface area of 1,580 m2, including the production departments (1,160 m2), warehouse (190 m2), auxilliary areas and plant rooms (230 m2).
A total of 250 resources work in the Manufacturing department.

This plant represents an example of our strategic choice to develop innovative and patient-friendly formulations and produce them entirely in-house. The site therefore accommodates, in a self-sufficient manner and on a single premise, all the various aspects of processing, from purification to the finished product, quality controls and packaging.

The creation of the plant involved hefty investments and required a number of particular design and logistic organisation measures to meet the highest applicable national and international quality standards.

The considerable investments made over the years have made it possible to improve the efficiency of the production lines, which in 2019 produced 16 million vials.

With this state-of-the-art plant, IBSA challenges one of the most complex and stringently-regulated sectors of the pharmaceutical industry, by developing and patenting novel purification techniques.

The hormones produced at the Lamone plant serve the entire IBSA group and directly supply a number of markets, including, in addition to Italy, Switzerland, Europe, South Africa, South America, the Middle East and Asia.

The plant, considered in the pharmaceutical industry as a centre of excellence, is subject to regular GMP compliance inspections by national and international authorities, including Swissmedic, the ANVISA and the Russian authority.

The quality system that governs all plant operations was designed to comply with the various international standards, including both those implemented in Europe (Eudralex, Volume 4) and the US (CFR), as well as the ICH and PIC/S guidelines.

The Manno plant in the Canton of Ticino, Switzerland

IBSA plant: Manno

The Manno manufacturing site produces thyroid hormones T3 and T4 (liothyronine and levothyroxine), in two pharmaceutical forms: soft gel capsules and liquid oral solutions in multi-dose and single-dose containers.
Soft gel offers the advantages of high dosing precision, greater bioavailability and better stability, while the liquid oral solutions of Levothyroxine are dispensed in single-dose strips that are easy to use even for those with swallowing problems or dysphagia, such as babies and the elderly.

The manufacturing site has a surface area of 3,950 m2 and it is composed of five floors of which four are used for production and one is dedicated to the air treatment systems as well as the systems used to produce the fluids required for the conditioning of the production areas:

  • floor 1 is home to the first oral solution filling and packaging line, a dispensing area in which all the excipients required for the production operations to be performed in the department are weighed and a material storage and transfer warehouse area;
  • on floor 2 of the building, the second liquid oral solution filling and packaging line is located.
  • floors 3 and 4 are dedicated to the manufacture of soft capsules: each floor, one the mirror-image of the other, is divided into a bulk area in which the excipients are received and processed to prepare the soft gel (fill and shells) required to form the capsules; from the encapsulation room, the heart of the department, the “fresh” soft gel capsules are transferred to a dynamic and static drying area. Once they have undergone visual inspection by an automated 100% control process using a high-definition video camera system, they are individually labelled by means of a laser etching system. The last step of the production process is packaging in blisters and secondary packaging for sale. All critical areas are kept under controlled temperature and humidity conditions.

At the current time, the productive cluster is staffed by a total of over 120 resources, considering the production facilities, Quality Assurance and Quality Control functions, Technical Maintenance Services and Warehouse Service.

All production steps are monitored by computerised systems that meet the Data Integrity requirements of the highest quality standards.

The soft gel capsules produced at the Manno plant serve the entire IBSA Group and directly supply a number of markets including Switzerland, Europe (Russia excluded) and the United States.

The plant, considered in the pharmaceutical industry as a centre of excellence, is subject to regular GMP compliance inspections by national and international authorities, including Swissmedic, the FDA and the Russian authority.

The site is authorised by the local authority Swissmedic, the FDA and the European authorities.

The quality system that governs all plant operations was designed to comply with the various international standards, including both those implemented in Europe (Eudralex, Volume 4) and the US (CFR), as well as the ICH and PIC/S guidelines.

The Collina D’oro plant in the Canton of Ticino, Switzerland

IBSA plant: Collina d'Oro

The CorPharma plant in Collina d’Oro manufactures and packages various pharmaceutical forms, including syrups, creams and ointments in tubes, oral liquids in stick form, tablets and hard gelatine capsules in blister packs, and granules in sachets, covering a number of therapeutic areas, such as the cosmetic dermatology and osteoarticular, pain and inflammation, respiratory, urology and cardiometabolic areas.

The production Cluster occupies a 3,600 m2 site and employs a workforce of 70 people on 13 different production lines. Each year, it processes 670,000 kg of starting materials and manufactures 132 million therapeutic doses. The various products are placed on the market in more than 80 countries worldwide. The Cluster is inspected regularly by both the national authorities and ISO certification bodies.
The site is authorised by Swissmedic, European authorities and those of the countries where the products are placed on the market.
The quality system that governs all plant operations was designed to comply with the various international standards, including both those implemented in Europe (Eudralex, Volume 4), as well as the ICH and PIC/S guidelines. The quality of both the products and the manufacturing operations is monitored constantly by the Quality Control department and supervised by Quality Assurance.
All operations regarding the manufacture of the bulk medicinal products and their primary and secondary packaging take place on production lines fitted with control and monitoring systems to guarantee optimum product quality and, therefore, patient safety.
IBSA implements a traceability system for its products and primary and secondary packaging, involving the application of a barcode and a 2D reading system on an innovative adhesive medium, so that the information cannot be tampered with or modified.

The packaging lines are therefore equipped with serialising systems that ensure consumer protection and safety through a correct management of the labelling of the packing processes and guarantee the reputation of the brand.

The production of ointments in tubes takes place using starting materials dispensed into BINS that are carried by an automated conveyor system to the vicinity of the production equipment, where a 2000 kg turbo emulsifier connected to 6 tanks directly feeds the 2 filling and secondary packaging lines. The turbo emulsifier, holding tanks and conveyor line are fitted with an automated CIP/SIP system.

The manufacture of syrups involves fitting a cap containing the active substance onto a vial filled with the solvent manufactured and held in tanks connected directly to the filling line and sealed with an aluminium disk. The vial is then labelled and provided with a measuring cup before being placed inside the secondary packaging.