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Core Competencies

Learn more about what Agno Pharmaceuticals can do to help you accomplish your goals.

Route Scouting

Process Development

Alternative Route Design

Crystallization Development

Impurity Identification

Stability Studies

Our process development starts with a meticulous, risk-based assessment designed to identify and address critical challenges

We engineer solutions that consider both short-term and long-term manufacturing needs, focusing on key deliverables such as speed, purity, and process reliability. This tailored approach is driven by our dedicated team of experts in process organic chemistry, process engineering, and analytical chemistry, all coordinated by a seasoned project manager.

Our process development scientists work closely with our analytical chemists to create customized analytical methods designed to support the characterization of your intermediates, RSMs, and APIs. From research-level to fully-validated methods, we ensure a thorough assessment of the stability of intermediates and final drug substances, all with a commitment to excellence and precision.

Some of the services we offer:

  • Synthetic route development/route scouting
  • Process development, optimization, and verification
  • Safety assessment and Process Hazard Analysis
  • Method transfer
  • Particle size optimization
  • Metabolite and impurity identification and synthesis (Including Nitrosamines)
  • Analytical method development and validation
  • Stability studies, and storage (IHC compliant), Photo Stability
  • Forced degradation studies
  • Reference and working standards qualification
  • Elemental/metal analysis

Additional Services

At Agno Pharma, our route exploration team specializes in refining your existing synthetic routes—whether sourced from published literature, discovery teams, in-house developments, or CMDOs—to create optimized alternatives better suited for production. We achieve this by:

  • Developing Innovative Synthetic Routes for Patent Protection
    Our novel processes have led to clients securing patents, such as WO 2016/064900 A1 and WO 2021/243171 A1.
  • Reducing or Eliminating Unnecessary Purification Steps
    We streamline processes by minimizing or eliminating steps like flash chromatography to enhance efficiency.
  • Optimizing Solid Forms
    We identify suitable solid forms to improve the purity of intermediates or final products.
  • Introducing Expensive Intermediates Later in the Synthesis
    We strategically incorporate costly intermediates at a later stage to reduce overall costs.
  • Agno Pharma has successfully filed over 60 patents for novel processes and published two peer-reviewed papers (OPRD 2012, 2021-2024 & OPRD 2024, 2659-2666), showcasing our commitment to advancing chemical process development.

At Agno Pharma, our expertise encompasses a range of both standard and specialized coupling technologies, including:

  • Suzuki Coupling Reactions
  • Enzymatic Chemistry
  • Boronic Acid Derivatives
  • Cryogenic Conditions
  • Raney-Ni Reductions (high pressure)
  • Phosgene Chemistry (hazardous reagents)
  • Diketene Chemistry (high exothermic reactions)
  • Nucleic Acid Chemistry (Solid/Liquid Phase)

At Agno Pharma, we have a proven track record of successfully transferring client R&D processes or developing laboratory-scale chemistry to our FDA-inspected manufacturing facilities. Collaborating with us ensures you align with a strategic partner dedicated to meeting your immediate needs while providing a clear path for long term success.

Flow Hydrogenation:

Agno pharma has implemented hydrogenation in a flow reactor on a manufacturing scale. Our clients can now enjoy several advantages that flow hydrogenation offers:

  • Less of expensive catalyst, e.g., Pd/C, is required
  • Faster workup and isolation process
  • Increased reaction selectivity
  • Higher yield
  • Increased safety

Enzymatic Chemistry:

The synthesis of RSMs, intermediates, and APIs can be facilitated through the inclusion of enzyme-catalyzed reactions. Our experts can design, optimize and screen enzymes based on each project’s specific demands. Synthetic route development results in a much more cost-effective and green process, taking advantage of the highly selective nature of enzymes, especially as a replacement of chiral precious metal catalysts.

These reactions are generally performed in an aqueous environment and at cooler temperatures thereby removing the need for hazardous chemicals in the manufacturing process facilitating a green chemistry approach.

Agno Pharma has filed more than 20 patents on enzyme-catalyzed processes, including lipases, esterases, proteases, transaminases, nitrilases, ketoreductases, and oxidases and published a peer-reviewed paper (OPRD 2011, 291-293).

Cryogenic Reactions:

Cryogenic reactions allow for better selectivity and control of impurity levels as well as the ability to work with unstable reagents. We have over a decade of experience working with cryogenic reactions such as Grignard reactions and metal-halogen exchange and difficult compounds supporting scale up through to commercial supply.

With the reactors ranging 50 L to 2,000 L capable of reaching temperatures as low as -90°C allows us to take on a project of virtually any scale.

Chromatography Systems

The process development/ optimization process generally involves significant effort to remove chromatography as it is an expensive and time-consuming operation. When this is not possible — or when removal of chromatography takes a back seat to expedited delivery, Agno Pharma is set up to accommodate client needs. Our large range of chromatography capabilities span from R&D lab scale through kilo scale and large-scale cGMP.

We offer the following capabilities:

  • Flash Chromatography XB3108 (up to 200 kg silica gel)
  • Flash Chromatography FB5108 (up to 40 kg silica gel)
  • Flange column FC50 (100 g loading)
  • Medium pressure DAC50 (100 g loading), DAC200 (1 kg loading) & DAC500 (>10 kg loading)
  • High pressure prep-HPLC (100 g loading)

Vacuum Distillation Systems

Vacuum distillation is a key technology to purify low-boiling materials. Agno Pharma has different types of vacuum distillation systems to accommodate project needs.

We offer the following capabilities:

  • Stainless steel distillation system (2,000 L, up to 2 mm Hg)
  • Glass distillation system (20 L, up to 1 mm Hg)
  • Wiped-film distillation system (0.25 m2, up to 0.5 mm Hg)

At Agno Pharma, we are dedicated to implementing green chemistry principles, focusing on crucial metrics such as E-factor and Process Mass Intensity (PMI) to evaluate and minimize the environmental impact of our processes. The E-factor measures the amount of waste produced per unit of product, while PMI assesses the total mass of all materials used in the process relative to the mass of the final product. By rigorously tracking these metrics throughout process development, we can objectively gauge and improve the environmental sustainability of our processes, ensuring that our methods are both efficient and eco-friendly.

Agno Pharma is committed to setting a long-term science-based target to reach net-zero value chain greenhouse gas emissions by no later than 2050 in line with the SBTi Net Zero Standard.