Charles Sternberg, Assistant Editor05.11.21
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. 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 may lead to significant cost savings when developing and manufacturing 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).
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 fully-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.”
Access to flow chemistry may lead to significant cost savings when developing and manufacturing 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).
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 fully-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.”
