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Product, Process and Analytical Development

Our extensive product, process and analytical development experience enables us to help you transition your products from discovery to the clinic and to market faster and with less expense and risk. Whether your product is in pre-clinical development, clinical trials, or already on the market, we can help increase its value by identifying opportunities for yield improvement, enhanced product quality, ease of scalability, greater process robustness, cost reductions, and reduced processing times. Our extensive experience working with CROs and CMOs can help you identify the best partners for your development and manufacturing needs and provide knowledgeable oversight of the development activities at your chosen vendor.

We also have extensive experience in the development and implementation of suitable analytical methods to assess purity, safety, potency, and stability of your product at all stages of development and commercialization. In all cases, we help ensure that your manufacturing processes and analytical methods meet all relevant regulatory expectations and requirements.

What We Can Do For You:

Whether you need our assistance to guide your staff in design, development and execution, or you need us to oversee and direct activities at CMOs and CROs,  we can help you in:
  • Cell line development from selection of optimal expression systems to preparation and characterization of cell banks

  • Upstream and downstream process development, including design of experiments, data review, and process evaluation and optimization

  • Analytical method development, qualification, and validation to support process development, product characterization, in-process and final product testing and stability

  • Drug product process development from formulation design and development to advice on container/closure systems

  • Preparation of pre- and post-approval comparability plans to ensure smooth implementation of process changes throughout development

  • Support for process development, technology transfer, and scale-up during outsourcing

  • Preparation of validation master plans, process validation protocols, and viral safety studies and oversight of these activities

  • Evaluation of the feasibility, cost, benefit, and regulatory impact of new process technologies