Services

Fast Track, High Quality

Our Timeline

In a few months we can assess the compatibility of your API with our technology and devise a strategy that maximizes the bioavailability enhancement. 

Using the strategy developed in the Feasibility study we develop and optimise a formulation that conforms to the required specifications within four months.

The unique formulation design is used to synthesize batches of Preclinical Trial Material using our cleanroom protocols and deliver you an in-vivo ready formulation in any variety of doses in capsules. 

Using our expertise with the production of our formulations, coupled with experienced and GMP certified partners, we can arrange the GMP production of clinical material for you. 


Feasibility Study
Formulation Development
Preclinical Trial Material
GMP

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Feasibility Study

By creating extended release drugs of orals we can improve the bioavailability of your API. SeraNovo performs oral drug delivery formulations or oral dosage formulations in a stage wise approach.

 

A feasibility study can be completed in a few months to support oral formulations and show the compatibility of your API and our technology. The results of the study indicate the significant solubility enhancement facilitated with our formulation platform. Our processes are designed to be flexible and fit our client’s timelines.

 

  • High Speed – Feasibility determined in a few months
  • Tailored Approach – All parts of formulation designed specifically for each API
  • Rapid Transition – Quick transfer to the next phase of formulation development 

 

Activities

  • DES design
  • Prototype dissolution – indicating current and potential bioavailability enhancement
  • Solubility optimisation
  • Stability – Physical and Chemical

Formulation Development

In this phase we strive for the best possible performance characteristics for the formulation, matched to in vivo conditions. We employ an iterative improvement process coupled with quick methods. Working at a small scale is a crucial factor in our optimisation, reducing API consumption. Using 96-well plate scale, SeraNovo can produce and test 100’s of formulations, selecting on the basis of gastric and intestinal solubility over time. Proprietary assays and models provide a detailed insight into in vivo performance. The formulation developed in this phase is similar to the final product and can immediately transition into the ATM phase. 

 

  • High Performance – Designed at every stage to enhance bioavailability
  • High Speed – High throughput testing compresses timelines
  • In-vivo Ready – Filled capsule as final dosage form

 

Activities:

  • DES optimisation
  • Polymer screening
  • Extensive dissolution optimisation
  • Stability
  • Production process optimisation

Preclinical Trial Material

Directly following the development and optimisation of a formulation we can prepare a batch under best clean conditions using our cleanroom facilities (Class D ISO 8). The formulation is pre-filled in gelatin capsules and closely resembles the finished dosage form, with no additional formulating steps required before GMP production and capsule filling. 

 

  • Dose flexibility – a variety of doses and capsule sizes can be delivered in the same timeframe
  • Short timeline – delivery of filled capsules within weeks
  • Trusted partner – compress timelines even further by using a SeraNovo recommended GMP provider experienced with DES formulations. 

GMP

The production protocols developed in the Formulation Development phase are easily transferrable to our GMP production partners. The technology is designed in such a way that scale-up of batches from small lab scale to Animal Trial Material (ATM) scale to GMP scale requires little or no extra time or optimisation. Typical production times of the synthesis part of our formulations are in days, not weeks or months. 

 

  • Seamless scale-up from lab scale to commercial scale
  • Production consultancy available (and recommended)
  • Capsule filling expertise outsourced
     

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