Indena meets custom services market needs through technological expansion
7th November 2019
According to the most recent international data, around 56% of pharma and biotech companies currently rely on outsourcing for the synthesis of small molecules in clinical phases, and one third for commercial molecules. At the same time, the CDMOs industry has been growing at twice – three times the growth rate of the pharmaceutical industry (as average) during the past two years in the developed markets (North America, Europe and Japan).
Indena decided to meet this growing demand by investing in new technologies to expand its offer for custom services and to capitalize on an almost century-long experience in the pharmaceutical market. In its main manufacturing site located in Settala (Milan, Italy), Indena installed in the last two years a new HPAPI kilolab, a pilot pharmaceutical plant, a PSD2spray dryer and upgraded its fermentation plant to multipurpose use.
Indena’s manufacturing site was already equipped with large scale isolators originally designed for the production of hundreds kg per year of semisynthetic HPAPIs with an Occupational Exposure Limit (OEL) of 800 ng/m3, which have been upgraded for the handling of even more toxic compounds (natural and synthetic), with an OEL in the range of 150 ng/m3. These large scale suites have been complemented by the opening of a brand new kilolab (LK2, in addition to an existing one, the LK1) devoted to the handling of extremely potent compounds, with an OEL of 20 ng/m3.
To better meet CDMO market requests, Indena opened a brand new pilot suite endowed with a high degree of flexibility for non-potent compounds, in terms of scale and operational conditions. Hence, the installation of a pilot pharmaceutical plant suitable for the GMP production of clinical batches, the manufacturing of non-potent intermediates and commercial batches requiring yearly productions in the range of tens of kg.
Still as a natural extension of a technology already practiced by Indena since several years, theinstallation of a Gea PSD2 spray dryer has been recently completed, to complement a large scale spray dryer working with organic solvents used by Indena since the 90s. PSD2 is a medium size equipment for clinical and commercial needs, that can handle class 2 organic solvents and is designed to carry out the production of APIs and pre-formulated APIs (through spray drying in the presence of excipients, classified as drug product intermediates) with a OEL of ≥ 10 μg/m3.
The last piece of this initial investment plan has been represented by the upgrade of an existing fermentation plant (once fully dedicated to a proprietary biotransformation) into a multipurpose equipment. The peculiarity of the plant (which features industrial equipment from 1,000 to 20,000 liter and is supported by 10 liter laboratory, 100 and 150 liter pilot scale fermenters) is the ability to ferment toxic compound, hence it is well integrated with the existing suites for HPAPIs, where the downstream can take place.