Custom development and manufacturing has traditionally been part of Indena’s strategy and offering. Find out more at stand 6B51
Early in 2018 Indena opened a new kilolab dedicated to HPAPIs (natural, fermentation, semisynthetic, total synthetic) capitalising on its experience in the area of high containment.
The company is now able to offer customised solutions for projects on complex molecules, with particular focus on the supply of APIs and APIs intermediates, highly potent APIs, pharmaceutical extracts, as well as food supplement and personal care ingredients.
All this from small-scale clinical supplies to large commercial batches (from grams to tons), in a full cGMP compliant environment and US-FDA inspected facilities.
The new kilolab is designed to handle the production of toxic substances requiring an occupational exposure limit (OEL) of 20 ng/m3: it implements the best available security procedures for people working in the lab and it deploys the best and most innovative technologies for containment preventing the accidental release of HAPI-materials outside the containment areas, including the use of glove-boxes and dedicated equipment.
This level of confinement also allows for handling toxins, such as maytansine derivatives, which can be used by ADC manufacturers.
The design of the new kilolab assures complete compliance with cGMP guidelines, offers maximum protection against cross-contamination and allows chemists to handle hazardous materials in an environment that owns the highest levels of safety.
The lab is able to perform full synthesis and HPAIs contract manufacturing services, including a full range of high- power manufacturing capabilities such as extraction, isolation, purification and synthetic modifications for active pharmaceutical ingredients on a wide range of scales.
The new kilo-lab is being followed by the building of a new multi-purpose pilot plant, designed for grinding, extraction, purification of toxic plants and equipped with columns for chromatographic purification, synthesis equipment, replicating in one place all the technologies available at Indena.
Building on its long experience and partnership tradition with client companies, Indena aims to systematically tap into opportunities complementary to its expertise, such as high containment fermentation and synthesis of difficult molecules.
The investment is also Indena’s reply to market demand for contract development and manufacturing services and the increasing reliance of pharma companies on Western suppliers as a risk reduction strategy compared to the past, when most of the developments and productions were outsourced to Asian providers.
Indena and Hyris are developing methods for genomic identification of botanical species based on unique sets of reagents for specific DNA sequences, called bKITs. These are part of the bCUBE technology, which finally allows full genetic analysis of biological samples in any setting. Among other purposes, the bKITs can be used within the bCUBE device to detect pathogens in a biological sample and to correctly identify the nature of the sample. Such bKITs are available for several plant species.
One of the latest examples of adulteration concerns the extracts of Saw palmetto (Serenoa repens, SP), the most expensive oil source of the pharmaceutical and healthfood market and consists of their replacement, or dilution, with cheaper substances. How difficult is to detect adulterations? What are the most interesting perspectives in fighting these dangerous practices?
Professor Giovanni Appendino will shed some light on this topics during the presentation “Champagne taste for beer price? Metabolomic and isotopic fingerprint of commercial Saw Palmetto (Serenoa repens) extracts” 10 October, at 11:50-12:20 at Pharma Insight Briefings, CPhI Worldwide, Hall 9, Stand 9C80.