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Api Synthesis Unit

API Synthesis Unit

With over 50 years of experience in pharmaceuticals manufacturing industry, Angelini Fine Chemicals is one of the major API manufacturers in Italy and Europe.

Angelini Fine Chemicals boasts a wide range of reactors with sizes up to 6000 liters, and over 140 m3 total reaction volume capacity, providing great flexibility in terms of scalability and chemical technologies by assuring a smooth, safe and optimized scale-up process, from a few kilos to multi-tons. With a well-established track record of custom synthesis (2-5 new products/projects developed each year), Angelini’s manufacturing chemists have the skill and experience to meet a wide range of pharma outsourcing services from proof of concept / route selection to technology transfer up to selection and development of new of manufacturing processes.

Angelini’s customers benefit from an extensive infrastructure with proven experience in development and manufacturing of APIs that are distributed into worldwide regulated markets:

  • Reactor pools with wide ranging flexibility in size (5 - 6000 L), media compatibility (glass lined, stainless steel & hastelloy) and operating range (temperature -20°C to +250°C and pressure up to 6 atm)
  • Batch sizes up to 1000 kg
  • Over 140 m3 of Total Reactor Capacity
  • Multiple product isolation technologies (centrifuges, filters, distillers, large-scale chromatography columns)
  • Multiple drying options (fluid bed and rotative vacuum dryers)
  • Multiple powder handling & finishing capabilities including sieving, blending & milling, micronazing

High Potency API Synthesis Unit

Angelini Fine Chemicals reinforces its technology portfolio, extending its manufacturing capabilities with a new cGMP manufacturing unit fully dedicated to development and small- and mid-scale cGMP manufacturing of custom High Containment APIs. The new, closed-controlled environment, high-containment manufacturing unit is equipped with reactor pools backed by unparalleled chemical process technologies and primary containment options with engineering controls to meet cGMP pilot batches for process scale-up and development, start-up batches, and full-scale cGMP manufacturing.

Angelini's customers will have access to a state-of-the-art manufacturing facility in order to perform High Containment API contract development and manufacturing services:

  • Handling of High Containment API down to exposure limits of 0.1 µg/m3 (OEB5)
  • Manufacturing vessels with high flexibility in size (300-2000 L), compatibility (stainless steel, glass- lined, PFA-lined) and operating (temperature from -20°C to +180°C and pressure up to 2 atm)
  • 5000 L of Total Manufacturing Capacity
  • Multiple filtration options
  • Drying options and powder handling (isolator technology)
  • Closed-controlled environment facility

The High Containment API manufacturing suite features an independent cleanroom (with ISO Class 8/Class D design) including a premier micronizer with a wide variety of mills and sieves that are in place to support tailor-made particle size reduction at scale from 1-100+kg batch sizes.

To expand this capability, Angelini Fine Chemicals has finalized the implementation of two Highly Potent Hubs to handle OEB5 and OEB6 products on a kilo scale. These two Hubs, independent from each other, can handle products with batch size respectively of 0,5-5 Kg and 0,2-2kg and can work simultaneously on different projects either for Clinical Development as well as for small volumes commercial products. Scale up into commercial manufacturing suite also possible depending on yearly commercial volumes.

Micro-Reaction Technology

Angelini Fine Chemicals is one of the first Italian CDMO investing in Flow Chemistry (FC) and Micro-Reaction Technology (MRT) for development and manufacturing of custom APIs

Equipped with new mini R&D flow lab, kilo-flow lab (pilot scale) and industrial flow continuous reactor, Angelini Fine Chemicals combines R&D chemists and engineers to assist process development and scale-up, from Proof-of-Concept (PoC) to your first mid-scale production run until technical transfer in commercial cGMP manufacturing.

Angelini Fine Chemicals brings extensive experience in flow continuous process development for the pharmaceutical manufacturing market, offering custom development and manufacturing services. An extensive R&D and manufacturing flow chemistry capacity comprising of over 25 industrial fluidic modules (1-250 mL) with 350 tons/year of total manufacturing capacity, enables Angelini to support clinical and commercial supply.

Our flow chemistry facility represents a milestone in Angelini’s long term plan for expedite drug development-to-market timeline of its customers and to access to novel chemical spaces in large-scale (hazardous chemistry, flash chemistry, photochemistry etc.).
With product approved and commercially sold over Europe and USA is at the forefront into the application of this novel technology for Pharmaceutical space.

API Finishing Unit

Angelini Fine Chemicals houses a cGMP compliant suite for API finishing operations. Equipped with premier particle size reduction (PSR) and blending equipment for all stages of API development, Angelini Fine Chemicals offers tailor-made API services for its customers formulation batch needs (early-stage development to large-scale clinical and registration/commercial batches).

  • Capacity: 300 tons/year of micronized APIs
  • 2 cGMP suites in independent cleanrooms (classified ISO 8) with independent air handling and HEPA filtration
  • Multiple blending technologies (500-2500 L)
  • Multiple sieves technologies
  • Jet mill micronizer
  • Closed-controlled environment facility
  • QbD approach to reduction particle size management