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Contract Development 
& Manufacturing

Contract Development &Manufacturing
Organisation 

At Eirgen Pharma, we take a tailored approach to each and every project that we work on with our partners. This means devising product-specific development strategies that bring your concept to market allowing you to meet your project goals and objectives on schedule. This includes the manufacture and packaging of Investigational Medicinal Products (IMPs) for clinical supply prior to a full scale manufacturing launch. With both non-GMP and GMP facilities available on-site, Eirgen Pharma offers a complete range of R&D solutions throughout all phases of the development stage. 

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PREFORMULATION PHASE 

  • Analysis of bibliographic data

  • Review of existing patents

  • Exploration of relevant physicochemical properties for candidate drug substances

  • Development of target product profile

PROCESS DEVELOPMENT PHASE

  • Enhancement of quality by design strategy

  • Development of process design space

  • Creation and implementation of robust and transferable processes allowing transition from R&D to production scale

FORMULATION DEVELOPMENT

  • Initiation of Quality by Design strategy compliant with ICH guidance and market specific regulations

  • Development of formulation design space

  • Material compatibility studies

  • Stable confirmation studies

  • Development of analytical methods

SCALE-UP (technology & site transfer activities)

  • Effective in-house handling of scale-up tasks

  • Minimisation of tech-transfer risks

  • Manufacturing process brought from optimisation to validation

  • Analytical methods validation

  • Quality by Design strategy finilised

FULL SUPPORT OF CLINICAL TRIALS
The Eirgen laboratories fully supports all phases of clinical trials providing:

  • Manufacture and release of clinical supplies

  • Clinical development strategy and planning

  • CRO management and oversight

  • Clinical trial application

  • Clinical trial stability program

REGULATORY OF STRATEGY & MANAGEMENT OF DRUG DEVELOPMENT 

  • Provide regulatory advice in the early phases of development projects

  • Interpret regulations and guidelines

  • Develop strategies for technical aspects of drug      development (quality, pre-clinical, and clinical)

  • Identify and manage external resources/experts

PROVEN TRACK RECORD OF SUCCESSFUL PHARMACEUTICAL DEVELOPMENT

From small scale non-GMP to clinical batches, the Eirgen team ensures delivery of your project on time and on budget, seamlessly. From the identification of the API to the delivery of your clinical product, a dedicated project manager supports an effective cross-functional team working within cell structures and ensures your project runs smoothly and timely.

Using this process with our partners in the past has allowed us to: 

  • Create safe, high-quality manufacturing pathways for the handling of teratogenic, cytotoxic, mutagenic and high bioaccumulation drug products.

  • Develop age-appropriate paediatric presentation of BCS IV molecule for renal treatment through the use of ER multi-particulate pellets.

  • Design various new presentations for ease of administration in oncology treatments:
    a. IR multi-particulates for ease of administration.
    b. Enteric-coated, modified release system.
    c. Amorphous solid-solid dispersions

  • Convert solvent-based processes to direct compression process. 

  • Undertake softgel formulation development of a cold temperature product with old formulation technology

Contract Drug Manufacturing

Eirgen Pharma devises and implements product-specific development strategies capable of delivering high-quality formulations and robust manufacturing processes

Want to learn more about our Contract Development & Manufacturing services? 

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