Flamma is a privately held Italian company, founded by Dr. Marco Maria Negrisoli in 1950. The Negrisoli family has been running the company since its foundation.
Today Flamma is an award winning CDO which provides a stable and reliable supply chain for Active Pharmaceutical Ingredients (APIs), New Chemical Entities (NCEs), Registered Starting Materials (RSMs) and Key Intermediates for the pharmaceutical, biotech, cosmetic and nutraceutical industries.
Flamma Group consists of 4 manufacturing sites, all operating under cGMP:
• Flamma S.p.A. located in Italy and based on 2 sites, Chignolo d’Isola (Bergamo), where is located the headquarters
and Isso (Bergamo).
• Flamma Honkai, located in Dalian (Liaoning province, China).
• Flamma USA (Malvern, Pennsylvania, USA).
Although Flamma has a great experience in Amino Acids and associated derivatives, begun in 1950, the company has gained a strong know-how in pharmaceutical manufacturing to provide a variety of intermediates and APIs. This involves the application of a wide range of chemistry, thanks to the implementation of specific technologies, such as cryogenic capabilities, continuous flow technology, hydrogenation and carbonylation. Indeed, Flamma development is driven by a constant investment in Research, Innovation and Technologies with a more and more increasing attention on safety process evaluation.
Flamma offers a great experience in GMP manufacturing of APIs and pharmaceutical intermediates, based on both a well skilled stuff able to handle different technologies and reaction conditions and a continuous effort to widen its know-how.
Thanks to this background, Flamma will be involved in Task 8.1 & 8.3 with the aim of applying 2 synthetic procedures developed by University of Pavia for the preparation of APIs (belonging to TINIB class) and a key intermediate for prostaglandins synthesis.
Particularly, these synthetic protocols will require the use of catalysts prepared by metals recovered from magnets thanks to the activities performed by the other partners involved in the project.
The R&D group involved in the project is in 2 different Italy sites (Isso and Chignolo).
The laboratories are equipped with 52 Labosystem hoods assimilated to secuflow, 4 Erlab hoods with high containment and HEPA filters, 1 Glove box, 1 hydrogenator, continuous systems (KILOFLOW (CHemtrix), equipped with ZAIPUT SEP-10 (membrane for separation in contitnuo) and multistage-extraction (kit for continuous multi-extractor) accessories, HUBER cryostats capable of reaching stably and constantly low temperatures (-78°C), Interchim PuriFlash for chromatographic separation. The CAPEXs provided enable a wide range of reactions to be performed by also making use of innovative technologies such as flow-chemistry that better meet the requirements of sustainable chemistry. In addition, solid state study and safety evaluation are currently part of process development: indeed, we can rely on suitable instrumentation such as: DSC Perkin Elmer, Optimax Mettler Toledo, RC! Mettler Toledo, TGA IR Spectrum 3 Perkin Elmer.
Being a pharmaceutical company, careful analytical control of both the processes and the products obtained is also essential. R&D is involved in fine-tuning these methods by making use of increasingly advanced instrumentation. Specifically, R&D at the Chignolo site where the project will be implemented is equipped with the following analytical instrumentation: 1 NMR (Bruker 400MHz, TOPSPIN software), 11 Agilent HPLCs (reverse & direct phase, including 8 Agilent 1290, 2 Agilent 1260, 1 Agilent 1100), 1 Agilent 1290 HPLC supported by ChromSward for analytical method development, 2 Waters HPLCs (ARC and H-CLASS), 2 Waters HPLC-MS (1 Waters H-CLASS/MS, 1 Waters H-CLASS interfaced with QDA specifically for DOE studies), 2 Agilent 1290 Bioinert MS and TOF respectively, specific for biomolecules such as 4 Waters GC-HS, 1 GC-MS, 1 Agilent 1260 Infinitive preparative HPLC, 1 UPLC, 1 potentiometric titrator, 1 K. F.
