Process Development & GMP API Manufacturing

Solvias offers a complete package of seamlessly integrated early phase API process and analytical development, catalysis, and solid-state services. Our expert team has handled hundreds of pharmaceutical process development and tech transfer projects with nearly 100% success rate.

We can deliver the API needed from preclinical all the way through phase III clinical trials. With direct access to our scientific and regulatory subject matter experts, our team will help you mitigate risk and deliver on time.

Integrated Services for Early Drug Development

We support your success with quick, efficient timelines, the quality that comes with years of experience and production in the quantity you need.

  • Implementation of PR&D concepts in lead structure analysis
  • Scalability considered in route scouting for future scale-up
  • Efficient and practical route design
  • Optimization of reactions and processes for scale-up
  • Workflow and isolation procedure streamlining
  • Expertise in asymmetric synthesis, hazardous chemistry, complex heterocycles, and catalysis
  • Seamless transition from mg to kg scale
  • Phase appropriate development with future scalability in mind
  • Non-GMP manufacturing and GMP API manufacturing
  • Comprehensive process and method transfer
  • Reference substance supply
  • More than 50 years industrial experience in applied catalysis
  • Rapid discovery of catalytic systems using expert HTE design and extensive ligand library
  • Meaningful discovery results in just one week
  • Most diverse library of commercially available ligands and catalysts
  • Salt, co-crystal and polymorphism screening for improved bioavailability, solubility, shelf life, yield and IP protection
  • Intelligent solid form evaluation of drug substances using predictive expertise
  • Crystallization development integrated into custom synthesis – a robust process is essential for consistent manufacturing
  • Spectroscopy (IR, Raman, NMR)
  • X-Ray powder diffraction
  • Thermal methods
  • Hygroscopicity (by DVS)
  • HPLC, CG, GC headspace
  • Karl-Fischer
  • Sulfated ash
  • Solubility
  • pKa
  • LogP/LogD
  • Stability of API & API excipient mixtures, physical, chemical, mechanical
  • ICP-OES

State-of-the-Art Equipment & Facilities

large reactors for gmp api manufacturing

Reactor Capacity to Meet Your Needs

Our reactors range in capacity from 8L to 160L with four fully equipped reactor trains including filters and dryers. Our total reactor volume capacity is ~850L.

Conditions-wide

Enabling a Wide Range of Conditions

We can work at temperature ranges between -80°C to 250°C with a range of -85°C to 160°C for GMP vessels. We have 8 safety boxes for mobile pressure reactors, HEPA filtered laminar flow cabinets and can employ up to 300 bar of pressure.

AddTools

Additional Tools for Project Success

We offer chromatography capacity up to 20kg for the stationary phase and have separation units with 50-150L volume. We offer high throughput catalysis screening and have a wide range of analytical capabilities.

Contact Us

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