Solvias AG - Biopharmaceutical Analysis, API Chemical Development, Polymorphism, Salt / Co-Crystal Screening

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As a former part of a major pharmaceutical company, Solvias supports the research and development of new drug substances and the optimization of manufacturing processes by designing flexible, customized programs and identifying the best solution to meet the customers’ needs. Emphasis is on industrial relevance.

Solvias customers benefit from a wide range of experience in the following areas:

Catalysis Development Services

Lead finding through high-quality screening, catalysis development and ligand/ catalyst offerings. Solvias also has a broad expertise in asymmetric hydrogenation and achiral heterogeneous hydrogenation.

• HTS-Screening
• Catalysis Development Services
• Solvias Ligands and Catalysis Products
• Asymmetric Hydrogenation
• CX-Coupling
• Heterogenous Hydrogenation

API Chemical Development

Full package of chemical and analytical services along the API Chemical Development Process from discovery to production:

• Lead Synthesis / Custom Synthesis
• Process Research and Development
• Kilogram Scale Synthesis
• API Synthesis
• High Pressure Chemistry (Hydrogenation, Carbonylation, Amination)
• Hazardous Chemistry (Fluorination, Phosgenation)

Polymorphism, Salt and Co-Crystal Screening

Comprehensive physical chemistry services for the identification and selection of polymorphs, salts, and co-crystals, including method development for polymorphic purity and the optimization of crystallization processes:

• Polymorphism
• Solid Form Screening and Selection
• Crystallization
• Method Development and Validation
• Quality Control of Drug Substances and Drug Product
• Support of Troubleshooting
• Salt Screening and Characterization
• Co-Crystal Screening

Analytical Services

Solvias offers Analytical services such as method development, validation and release testing with a broad technology base:

• Highly Active and Highly Toxic Substances
• Analytical Characterization
• Method Development and Validation
• Quality Control Analysis
• Stability Studies
• Leachables and Extractables
• Reference Substances
• Elemental Analysis
• Microbiology
• Environmental Analysis
• Manufacturing Support

Biopharmaceutical Analysis

Biopharmaceutical analysis services for protein-based drugs to biotechnology and pharmaceutical companies at every stage of drug development:

• Characterization Programs
• Method Development and Validation           
• Release Testing
• Stability Studies
• CE-Technologies
• Nuclein Acid Analysis
• PCR Technology

Process Analytical Technology / PAT

Delivering comprehensive Process Analytical Technology for continuous monitoring of your chemical production and formulation processes:

• Fiber-optic Probes
• Liquid transmission Flow Cells / Immersion Probes
• Gas transmission Flow Cells
• Diffuse Reflectance Immersion Probes
• Transflection Immersion Probes
• ATR Immersion Probes
• Process Analytical Solutions

CN Coupling Technology

• CN-Coupling: ppm-Level Catalyst Loading for Efficient Buchwald-Hartwig Amination »
  Solvias has exclusively licensed a highly efficient CN-coupling technology for aromatic and heteroaromatic chlorides, bromides and sulfonates with amines and imines from Yale University (US patents 5,977,361 and US 6,235,938 B1).
  
  

Co-Crystals

• Co-Crystals – An Attractive Alternative for Solid Forms »
  Though co-crystals were discovered in the 19th century, the pharmaceutical industry has only recently become interested in their potential applications.
  
  

Doxorubicin Synthesis

• From Daunorubicin to Doxorubicin: A New Synthesis Process »
  Process research and development involves more than just finding the right synthesis route. The crystallization of the API or intermediate products in the most appropriate solvent system is just as significant.
  
  

Drug Substance Development

• Integrated Process Research and Development by Solvias: Basis of an Efficient and Successful Drug Substance Development in the Pharma Industry »
  Growing competition compels pharmaceutical companies to launch new and effective drug substances more quickly by optimising their pipelines and streamlining their chemical development programs.
  
  

Fluorinated Compound Synthesis

• Selective Synthesis of Fluorinated Compounds: Process Development and Preparation of Fluorinated Compounds on a Kilolab Scale »
  Our expertise in fluorine chemistry and the synthesis of small molecules allows Solvias to develop sophisticated synthesis processes for complex organo-fluorine compounds.
  
  

High Throughput Catalysis Screening

• Solvias to Introduce High Throughput Catalysis Screening Services »
  Solvias launches its first full-scale HTS Screening Service for asymmetric homogeneous hydrogenation.
  
  

Highly Functionalised Chiral Scaffolds

• Lautens Technology: A Novel Scalable Synthetic Method for Highly Functionalised Chiral Scaffolds »
  
  Dr. Michael Quirmbach
  The hydronaphthalene skeleton is found in a wide range of compounds possessing diverse biological activities. A number of drug candidates in various clinical phases, as well as natural and launched products, contain this privileged scaffold with chiral substituents (a selection is depicted in figure 1).
  
  

Microbiological Testing

• Microbiological Testing: Harmonization Between the Major Pharmacopoeias »
  
  Dr. Aldo Hörmann
  In a major step towards global harmonization of pharmaceutical product testing, the European, United States and Japanese Pharmacopoeias have revised their regulations on microbiology testing.
  
  

Process Analytical Technology

• Process Monitoring with Near Infrared Spectroscopy »
  
  Dr. Simon Dodds
  Solvias AG discuss new innovations in process analytical technology (PAT) and examine the benefits of using near infrared (NIR) spectroscopy
  
  

Process Development

• Process Research and Development in Early-Phase Chemical Development »
  The Role of Process R&D in Early Chemical Development: Pay Now or Pay Later
  
  

Quality Control of Protein Therapeutics

• Quality Control of Protein Therapeutics: ICH Guideline Q6B »
  As part of the biotechnological revolution, the first recombinant protein therapy - human insulin - was launched into the pharma market in 1982. Since then 119 additional recombinant proteins have been released – among them 6 blockbusters.
  
  

Selective Heterogeneous Hydrogenation

• Selective Heterogeneous Hydrogenation: A Valuable Tool for the Synthetic Chemist »
  
  Dr. Hans-Ulrich Blaser
  Next to the "glamorous" homogeneous hydrogenation highlighted by the 2001 Nobel Prize award to Noyori and Knowles for the enantioselective version, the more traditional heterogeneous hydrogenation may seem a bit old-fashioned and thought not to have much of a future.
  
  

Solid-State Development

• Crystallisation: Its Relevance During Solid-State Development »
  The solid-state form of a drug can have a major impact on its efficacy, formulation, production, and storage. It is therefore highly advisable to thoroughly evaluate the solid-state properties of the drug substance and the crystallisation conditions for its preparation.
  
  

Therapeutic Protein Substances

• Determination of Detergents in Therapeutic Protein Substance »
  The following article as published by Pharmaceutical International concerns Therapeutic Protein Substances.
  
  

Toxic Substance Analysis

• Analysis of Highly Active and Highly Toxic Substances »
  
  Dr. Aldo Hörmann
  In recent years, the number of extremely active and toxic active substances in the pharmaceutical industry has greatly increased.