Services

PharmAgra Labs delivers the high-quality custom synthesis and contract research services necessary to accelerate your internal research and development programs.

PharmAgra Labs has the skill and experience necessary to meet a wide range of outsourcing needs. We can assist clients with all phases of the discovery-development-clinical process. At its core, PharmAgra Labs is a chemistry company wholly focused on the preparation of mg to kg quantities of target molecules for our clients.

PharmAgra Labs delivers the high-quality custom synthesis and contract research services necessary to accelerate your internal research and development programs.

We provide medicinal chemistry support services for the synthesis of target compounds, reference compounds, starting materials, intermediates, specialized reagents, and other compounds of interest. We can also develop divergent synthetic routes for rapid analog preparations in support of SARs studies.

Our chemists work in a well-equipped facility with ready access to literature/reaction databases and literature retrieval services.

Some examples of our services include:

  • Medicinal chemistry support services
  • Synthetic route design and optimization
  • Resynthesis
  • Preparation of starting materials, intermediates, and final targets
  • Preparation of reference compounds and metabolites
  • Small-volume (mg-kg) manufacturing
  • Combinatorial building blocks
  • Chiral synthesis/enantiomeric resolution
  • Stable isotope derivatives

PharmAgra Labs has developed efficient manufacturing processes from a number of laboratory-scale syntheses (obtained from literature, client and/or PharmAgra research). Our management has experience with cGMP manufacturing in equipment up to 2,000 gallons. This knowledge and experience enables us to develop efficient, real-world solutions to our clients’ production needs.

Recent projects include a successful multiyear collaboration with a small biotech company requiring the development of a commercial API manufacturing process starting from a 12-step medicinal chemistry route. We designed a new manufacturing process that we used to produce multi-kilogram lots of product. This process was later transferred to a large scale cGMP manufacturer. Production of key intermediates was transferred to both domestic and offshore suppliers.

Other projects include the development of commercial multi-kilo processes for several generic drugs that have been transferred to large-scale manufacturers. We have also developed an efficient kilo-scale photochemical manufacturing process for a pharmaceutical intermediate.

Process chemistry services include:

  • Process development
  • Route scouting and selection
  • Optimization
  • Scale-up
  • Process documentation
  • Tech transfer services, domestic/offshore

When your API is ready to transition to the clinic, PharmAgra Labs can rapidly and economically meet your requirements for API Clinical Trial Material. We synthesize milligram to multi-kilogram lots for clinical studies and low volume commercial production in our cGMP synthesis laboratory (see facility section). A wide range of chemical processes can be accommodated in glass reactors up to 72 liters. Larger quantities can be accommodated by transfer to large scale cGMP manufacturers.

We are an FDA inspected facility. We successfully completed our first FDA pre-approval inspection (PAI) in July of 2009 with no 483’s issued.

Our cGMP services include:

  • Synthesis of milligram to multi-kilogram lots for clinical studies and commercial production
  • Process validation
  • IND / NDA / ANDA support documentation
  • Impurity isolation, characterization and synthesis
  • Analytical methods development and validation
  • Impurities identification and synthesis
  • Reference standard preparation, characterization and documentation
  • API stability studies according to ICH guidelines
  • Product release testing

PharmAgra provides in-house production of mg to kg quantities of both cGMP and non-cGMP materials. If your production requirements exceed our in-house capabilities, we have good working relationships with domestic and offshore large-scale manufacturers. We can also provide technology transfer services to clients who want to work directly with their manufacturers.

Production services include:

  • Production using client-provided or PharmAgra-developed processes
  • In-house production, mg to kg scale for cGMP and non-cGMP products
  • Manufacture of up to MT quantities using domestic or offshore collaborators
  • Technology transfer to client-specified domestic or offshore manufacturers
  • Process validation

PharmAgra Labs routinely solves complex analytical problems as part of our custom synthesis program. We have therefore developed significant expertise in analytical chemistry services, which we offer as a stand-alone service to our clients. These services include:

  • Analysis and interpretation using HPLC-DAD/ELSD, GC (MSD/FID), LC/MS, 400 MHz NMR (1H, 13C, 19F, 31P), FT-IR, etc.
  • Analytical methods development and validation
  • cGMP analysis
  • Product release testing
  • Identification of unknown compounds
  • Separation and identification of complex mixtures (optical isomers, geometric isomers, etc.)
  • Chemical conversion/derivatization in support of difficult analytical determinations

PharmAgra makes available a broad range of useful chemical intermediates. Please select search or view all to access our existing products database. Select custom synthesis for information on how to request a custom synthesis quote.

All of the compounds listed in our database have either been made by PharmAgra in the past or are available from a PharmAgra partner company.

Please note that the listed compounds may or may not be in-stock. Feel free to search our database and inquire as to product availability.

Our scientists offer the extensive expertise in Organic Synthesis and Analytical Chemistry required for successful litigation. We understand that speed, effective communication, reliability and confidentiality are critical to successful outcomes.

  • Patent Procedure Replication: Careful replication/documentation of patent procedures with extensive analytical support. We have significant experience supporting activities related to the Hatch-Waxman Act.
  • Life sciences: Support legal challenges facing pharmaceutical, medical device and other companies involved in the life science industry.
  • Patent infringement litigation support: Support IP challenges by designing experiments to evaluate chemical synthesis/manufacturing processes.
  • Case evaluations and data review: Assist with scientific evaluation of claims, including the review of opposing data, interpretation of technical results and conclusions.