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ATMP Sweden Process map Product developer process map

Product developer process map

Welcome to the landing site for the ’Product Developer’. Your role is to ensure that the science behind your product is sound and that adjustments to the product to suit quality, manufacture, regulatory, clinical and commercial needs land in the most efficacious product possible. You also have an important role in the development of new analytical platforms to demonstrate the safety, identify and potency of your product.

Below you can see our ’process map’ that shows what you need to be considering at what stage of ATMP development. There are other process maps for manufacture, regulatory, clinical and commercial needs, that can give you tips on how to address these needs in your team. The objective here is to have the right people considering the right things at the right time to ensure that your ATMP pipeline moves forward as effectively as possible, good for patients in need, good for your pocket to not waste money and time on inefficiencies.

Product Developer

  • 1. Research adaptation

  • 2. Process qualification

  • 3. GMP manufacture

  • 4. Clinical Trials

  • 5. Market approval and reimbursement

  • 6. Standard of Care

Below you will find extra links and tips relevant to the above phases of development for your role.

Process development

  • Identify your quality and CMC experts consultant
  • Strategic planning for phase specific development, national versus international strategies consultant
  • Non GLP proof of concept, safety and mechanism of action
  • Analytics: Identify/develop assays to characterise the product (understand and optimise the product behaviour) and safety. Are there existing FDA/EMA approved assays?  Identify essential testing for Phase III/Market approval. Are there appropriate toxicity studies approved by the EMA/FDA?
  • Identify commerically suitable start material and appropriate tissue establishment (cell therapy products). Ideally, collaborate with tissue establishment to standardise the collections as well as develop a protocol optimised for the target cell type.
  • for allogeneic pluripotent stem cell derived cell therapies it is critical prior to phase I to identify commercially suitable start material to avoid changing start material (and thus the product) post phase I and having to repeat the phase I study consultant
  • Test raw materials and equipment with better GMP, quality, commercial and clinical profiles.
  • Determine what the product is eg. autologous/allogeneic, cryopreserved/37deg C, batch size (consider analytical needs), fill/finish, container closure system, scaleability – this becomes your TPP along with commercial aspects
  • define process with validated cell counting method
  • test functionality and survival of cells in drug product and dose preparation formulation and composition
  • ’lock’ raw materials, process and analysis methods for qualification moving forwards.
  • Who is responsible for the Clinical needs, Commercial aspects, GMP manufacture and Regulatory Affairs needs in your translation? Get support in building your team! consultant

Process qualification

  • proof of concept and mechanism of action for Phase I are often from research grade studies
  • pivotal studies for pre-clinical package (safety/tox) are done using product that is representative of the clinical process.
  • where feasible all pre-clinical/non-clinical studies are performed under GLP, ensure within final reports that full batch traceability is included to faciliate regulatory document authoring
  • qualification batches should be manufactured in compliance with GMP
  • technical batches/engineering runs may or may not be performed under GMP depending on standard procedures at manufacturing site. These runs are not normally produced with fully approved batch records. These batches can be used for shelf life stability and in use stability
  • if a prediction cell line is generated a report should be prepared that documents how the cell line was generated, where the parental cell line came from, what materials (particularly of animal origin) were used in preparation for manufacture of master cell bank at manufacture facility
  • Cell banking needs to be performed in compliance with GMP. Cell bank characterisation should be performed in compliance with regulatory guidance. Microbial safety testing assays should be compendial and therefore validated.
  • genetic integrity of start material, product and lack of disease causing genes
  • genetic stability becomes more important with larger batch sizes

Product Manufacture

  • GMP batch produced, tested and released
  • product developer to participate in the evaluation/assessment of any out of specification (OoS) results and/or deviations that may impact the product quality/safety

Clinical trials

  • comparability studies
  • scale up product to commercial scale

Market approval and HTA

  • safety and efficacy approved by regulatory authority eg. EMA
  • National healthcare negotiation/pricing
  • TLV/NT-Rådet recommendation and pricing

Clinical routine

  • effect data, safety and reporting
  • trials for new indications, next product