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cGMP Capabilities

Nanosyn personnel work with a scale-up mentality and listen closely to insure matching up our response to best fit a client’s needs. Our chemists are capable of designing a process from scratch, developing and optimizing a discovery process to prepare for scale-up on site or at a larger scale elsewhere, or providing rapid turnaround of a product by an existing process. 

Typical Project Flow:

  • CDA put in place
  • Initial technology transfer and evaluation
  • Development of project proposal and project initiation
  • Assignment of project manager and team and agreement on customer preferred project communication plan
  • Initial process review in lab
  • Process development/improvement/optimization as needed
  • In-process analytical methods identification
  • Initial scale-up of product, usually to meet preclinical toxicity testing needs (10-50 grams)
  • Additional non-cGMP scale-up, often for use for preclinical formulation development (100 grams to 2 kgs)
  • Development of cGMP Master Batch Record from previous process qualification lab work , including raw material identity testing and final product release testing
  • cGMP production and QA/QC final product release testing
  • Ongoing regulatory support or technology transfer as needed

R&D Services include:

  • Process identification
  • Process Development
  • Process Optimization
  • Process Scale-up
  • In-process analytical methods
  • Final product analytical methods development/verification
  • Polymorphism screening studies
  • Isolation and identification of impurities
  • Technology transfer

cGMP Services include:

  • cGMP Master Batch Record and associated documentation preparation
  • Raw material identity testing
  • cGMP production
  • Final API QA/QC release testing
  • Reference standard preparation and testing
  • Technology transfer
  • Specialty packaging and shipping as needed

Analytical Services include:

  • Methods development/ verification/ and validation
  • Quality control testing
  • Stability Data

Regulatory Services include:

  • Preparation of cGMP process documentation
  • Writing of regulatory approval documents for CMC sections, Drug Master Files, and IND/NDA submissions

Chemistry capabilities:

At our kilolab scale in Santa Rosa, we can handle most chemistries safely and efficiently. Some of our recent chemistry challenges have involved working with lithium aluminum and sodium hydrides, hydrogen sulfide, and performing Suzuki couplings, Mitsunobu reactions, hydrogenations, specialty polymerizations, and diafiltrations. 

Nanosyn’s chemists stress the replacement of process steps involving expensive and time consuming chromatographies, but have extensive experience with operating chromatographic techniques when necessary. Specialty equipment beyond traditional gravity flow glass columns includes Biotage Flash 150, Biotage Kiloprep, and an Isco all plastic system.

Handling capabilities:

Nanosyn’s internal operating procedures stress the development and operation of safe processes. Some of our recent handling challenges have included working with air, moisture, and light sensitive compounds. The handling of highly toxic compounds is evaluated on a case by case basis. If necessary for toxic compounds, we can work in a disposable glove bag in a fume hood with personnel in full body suits with self contained air supply. For safety reasons, and at the request of clients we do not bring on site compounds with known potential acute hazards at very low levels such as penicillins and steroids. 

The site is registered with the DEA for Schedule II, III, and IV controlled substances.

Product and Equipment storage services:

  • Equipment purchased and dedicated to cGMP manufacture will be stored for clients on-site during the term of the project, including extended clinical trials
  • Finished APIs, retained samples, and intermediates and raw materials will be stored on-site with the appropriate chain of custody documentation as required by regulatory or client needs

Specialty equipment includes:

In addition to the specialty chromatography equipment listed above, the site has the capability for large scale rotary evaporation and a wiped film evaporator, and is continually adding more equipment as needed to increase site capabilities.

 

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