Aprilia (LT), 10th May 2021.
Today, a confluence of factors is driving the need for a paradigm shift in pharmaceutical manufacturing strategies in order to accelerate R&D pipeline to market. Movement towards rising generics competition, dramatically higher clinical trial costs and timelines, the shift away from blockbusters to niche products, and the growing number of candidates with accelerated development designations (Fast Track, Breakthrough Therapy, Orphan Drug) are all placing pressure on drug manufacturers to eliminate inefficiencies and increase productivity in order to reduce development costs and get new therapies to the market more rapidly. Flow chemistry is playing an increasingly important role in the pharmaceutical industry nowadays and is becoming part of the chemical toolbox of more and more process development programs, leading significant benefits of drug development-to-market cost and timeline.
Access to flow chemistry at virtually all scales and affordable cost, it may lead significant cost saving for develop and manufacture of new drugs. In terms of capital expenditure (CapEx), the comparative investment for a new continuous flow facility can be up to four times less than the expenditure on a comparable batch facility. Additionally, continuous flow requires less work for quality assurance / quality control (QA / QC) and may lead to fewer analytical procedures, representing a reduction of up to 20% in operating expenditure (OpEx). The small size of the microreactor, either PFR (Plug Flow Reactor) or CSTR (Continuos Flow Stirred Tank Reactor), offers high surface-to-volume ratio which translates into more efficient mixing, heat and mass transfer than traditional batch reactor, ultimately leading to higher yields and better product profile with fewer impurities. This feature is especially useful in handling reactions that are highly exothermic (such as hydrogenation, oxidation, nitration), or require hazardous or unstable chemicals (such as halogens, cyanides, carbon monoxide, ozone). Dealing with toxic chemicals is also safer – cytotoxic APIs can be produced in inexpensive, dedicated, and disposable equipment sets for production of low volumes of these compounds in the laboratory fume hood. Moreover, important process parameters such as mixing, temperature, pressure, flow rate, reaction residence time are under rigorous control, allowing fast parameter screening and process optimization. Due to the tiny volume and high controllability, flow chemistry permits to access to novel chemical spaces on large-scale, opening the opportunity to develop new chemical reaction under conditions that are considered difficult or even impossible in batch reactors (e.g. flash chemistry, high temperature/pressure).
Responding to the rising number of new active pharmaceutical ingredients (APIs / HPAPIs) that require specialized and niche chemistry, Angelini Fine Chemicals – business unit of Angelini Pharma S.p.A. – is one of the first European CDMOs (Contract Development and Manufacturing Organizations) investing in flow chemistry and micro-reaction technology for research, development, and cGMP (Current Good Manufacturing Practices) production of small molecule Adv. IMs., APIs and HPAPIs for pharma market. Equipped with new state-of-the-art R&D flow lab, kilo-flow lab (pilot scale) and industrial cGMP facility, Angelini Fine Chemicals offers a full-integrated CDMO platform to meet and assist its customers at any drug development stage – from R&D feasibility study runs to Proof-of-Scalability up to your first mid-scale and commercial production – and at any scale demand – from 1-100+ kg up to multi-tons of product demand.
“As a leading CDMO partner for the branded pharmaceutical industry, at Angelini Fine Chemicals (Business Unit of Angelini Pharma S.p.A.) exciting research programs are underway to develop new synthetic and catalytic methodologies for continuous manufacturing of custom APIs / HPAPIs. In terms of challenging chemotypes, flow chemistry is a heavily investigated to improve process chemistry metrics (such reaction yield, chemo-, regio-, stereo-selectivity and E-factor) and safety / environmental / quality profile of batch processes. Our pharmaceutical customers benefit our flow chemistry expertise to running a wide reactions portfolio such as Nitration, Azide Chemistry, Organometallic Chemistry (Organolithium reagents and Grignard reagents), Bromination, just to name few examples of the last “Proof-of-Scalability” that have recently successfully archived in our Plant on behalf of custom synthesis projects”, commented Jacopo Buzzanca, Custom Synthesis Manager of Angelini Fine Chemicals. He added, “Building on our long industrial experience in continuous manufacturing, pharmaceutical customers see Angelini Fine Chemicals as an attractive CDMO partner for their API / HPAPI development programs. Accessing to our new Flow Chemistry Platform benefits to R&D programs of our customers for exploring novel process windows, far to conventional practice and under harsh chemical environments, to take on project projects that have an extra dimension of risk”.
Angelini Fine Chemicals
Since 1967, Angelini Fine Chemicals is at the forefront of research, development and cGMP manufacturing of Adv. IMs., APIs and HPAPIs for Company brand business and its pharmaceutical customers & partners. Located in the industrial outskirts of Aprilia (Southern Rome Area, Italy), with 70.000 m2 cGMP manufacturing facility and cutting-edge R&D labs, Angelini Fine Chemicals is housing a wide reaction technology portfolio and scale-up capabilities to meeting small molecule outsourcing needs of pharmaceutical industry – from Proof-of-Concept to early-stage clinical lots run until cGMP commercial manufacturing, from 1-1000+kg up to MT scale. Our continuous programs of investments in R&D and novel chemical technologies (such as Flow Chemistry and High Containment API), coupled with our 50 years of industrial chemistry experience, make Angelini Fine Chemicals an attractive and trustworthy CDMO partner on relying for expedite R&D pipeline development-to-market. Within our manufacturing size we produce more than 300 tons of APIs for year (40% under CDMO activities).
CONTATTI
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FINE CHEMICALS SALES & BD | ANGELINI PHARMA:
Giovanni De Filippo, Fine Chemicals Sales & BD Head giovanni.defilippo@angelinipharma.com
Jacopo Buzzanca, Custom Synthesis & BD – APAC jacopo.buzzanca@angelinipharma.com
Carlo Lusso, Custom Synthesis & BD – EU carlo.lusso@angelinipharma.com
Gary Conte, Executive VP BD – US gary.conte.consultant@angelinipharma.com
