R&D

Experience you can trust is the best way to describe R&D in Dipharma.

From the beginning, Dipharma recognized the importance of investing in innovation. Today, with over 250 patent and patent applications filed and more than 1200 scientific papers written with our scientists’ contribution, expertise in process chemistry is one of our core competencies.

A team of more than 60 highly skilled professionals (the majority are masters and PhDs) is to conceive of new chemical synthetic routes and to transform them into industrial manufacturing processes for both our product portfolio and custom applications.

This enables us to offer our custom synthesis or generics customers the most efficient and cost-effective chemical process solution for their desired molecule. Our R&D team is backed-up by an internal Intellectual Property department.

Our trademark characteristics are a rigorous approach to defining synthetic chemical processes, a high level of skill in the safety assessment, a thorough multi-disciplined expertise in our portfolio of technologies, and an innovative mindset.

R&D mission
Innovation at work

We innovate by developing new processes by applying the latest methods and technologies
to the existing ones by revision and optimization for the chemical reactions and processes involved.
This approach is applied to both generic products and custom synthesis.

Exclusive synthesis

Our R&D team is able to provide a wide range of CDMO service:

  • Custom synthesis of difficult molecules, including heterocycles, small peptides, and natural products.
  • Process route development and optimization to enable scale-up of early stage compounds, up to commercial scale.
  • Process impurity identification and synthesis.
  • Process chemistry re-design.
  • Handling of High Energy and Hazardous reactions (High Pressure Hydrogenation).
  • Sourcing optimization for cost effective process routes.
  • Safety assessment and calorimetric study
  • Analytical development (on site QC/ analytical department).
  • Solid state characterization.
  • Pre-formulation evaluation.

Catalogue APIs

In the development of new API’s our R&D team delivers five key elements:

PROCESS RESEARCH

A cost-effective and non-infringing process is the main target when starting a new project.
To achieve this goal new synthetic methods and innovative technologies are always considered.

SUPPLY CHAIN EVALUATION 

Suppliers for main raw materials are identified and selected based on reliability,
quality, geographical risk mitigation and cost competitiveness.

ANALYTICAL RESEARCH 

A full and detailed characterization of products and intermediates is undertaken by a team of skilled technicians, in order to ensure the highest quality requirements for the products under development and the analytical processes that support them.

PROCESS DEVELOPMENT

Rigorous definition of the process parameters, conditions and complete safety assessment are the requirements for an easy scale-up, whether it be hazardous or standard chemistry.

PROCESS INDUSTRIALIZATION

Our R&D team, together with a team of process engineers, supports all the scale-up phases until the process is validated and the first industrial batches are successfully produced. These practices ensure a complete and smooth transfer of technology from R&D to the production teams.

Areas of expertise
Our growing portfolio of reactions

We are proficient in the following reactions and technologies

Laboratories
and equipment

Our two fully equipped R&D Centers are located one in Italy, near Milan, and the other in Kalamazoo (MI), USA.

They both have a state-of-the-art complement of instrumentation and equipment that include:

  • Multiple HPLC and UPLC, with UV and RI detectors
  • 4 HPLC-MS/Single and Triple Quadrupole
  • Preparative chromatography systems, including UV/ELSD detectors and reverse-phase prep capability
  • Ionic chromatography
  • Parallel reactors for catalyst screening, autoclaves for gas, liquid reactions
  • GC and GC-MS systems
  • ICP-MS
  • NMR: one 400 and two 300 MHz NMRs, with auto-samplers and variable temperature. Multiple ion probe H, F, C, N, P, etc.
  • KF Titrators (volumetric and coulometric + Stromboli)
  • XRPD
  • Lab Miller
  • Lab Micronizer
  • Particle-size analyzer (Malvern)
  • Reaction Calorimeters RC1 and Labmax®
  • Spray Dryer
  • DSC
  • 2 NON-GMP K-labs for preparative purposes
  • Electronic Notebook System
  • Turbidimeter Crystal 16® for crystallization screening
  • Pre-formulation Lab (dissolution test apparatus, blender, tablet press, etc.)

Managing supply for clinical Phase 1 and early Phase 2, this cGMP manufacturing suite strengthens Dipharma’s CDMO offering. It is supported by a state-of-the-art cGMP Quality Control laboratory.

  • 2020 cGMP, FDA registered
    FEI: 3004853226
    DUNS: 137538224
  • Wet chemistry Line
    – 30 L (2) mobile reactors with walk-in hoods for up to 10 kg output (chemistry dependent)
    – Temp ranges -40 C to 200 °C
  • Dedicated teams to support the wet line with development for custom synthesis API projects

The cGMP pilot plant, located in our production site of Mereto, was built in 2014. It is currently equipped with:

  • Reactor capacity from 200 to 1000 L (ss/gl)
  • Hydrogenation pilot plant (Biazzi® technology) (200 L, 20-40 bar)
  • Nitration (continuous) pilot plant
  • Finishing department with multiple milling/sieving capabilities

A second reactor train with a containment capability up to OEB4 (OEL not less than 1 ug/m3) set to open in late 2021.

Innovation:
Publications and Patents

A fundamental objective of a granted patent is to provide an incentive for innovation.
A patent, in fact, gives to its owner the right to prevent third parties from making, using, or selling their invention.
At Dipharma, we value, respect, and benefit – together with our partners in a custom synthesis project – from this protection.
An internal team having European and Italian Patent Attorney qualification and documentation specialists, who work directly with a network of national and international legal agents, handles all aspects of this protection at Dipharma.
The decision to protect an invention is driven by our Intellectual Property team in collaboration with the top management, with the main goal to strengthen our competitive position, and thereby helping to increase the competitiveness of our customers.
As witness of our innovation, we have filed over 250 patents and patent applications and our scientists contributed as authors in more than 1200 scientific papers.

Scientific partners,
Strong partnerships

To back-up our team, Dipharma has strong and long-standing partnerships with some of the best universities and research centers in Europe. Moreover, Dipharma financially offers grants to students or graduates involved in our research programs.

If you are a researcher in chemistry and you are interested in collaborating with Dipharma, please visit our CAREERS page