Our global quality and regulatory teams support your project at every stage – from pre-IND to marketing authorization of your cell and gene therapy (CGT) products. With our experience over the last 30 years and in more than 50 countries, we have all the building blocks to accelerate your regulatory submissions.
We are your partner with extensive experience to take your CGT product from bench to clinical trials and beyond. This includes early identification of the right raw material in compliance with regulatory requirements for an easy transition from process development to clinical trial approval. In total, we have supported dozens of clinical trials that have successfully transitioned into pivotal trials and marketing authorizations. To support your needs worldwide, we have built highly dedicated global quality and regulatory teams that work with you for a smooth integration of our product information into your submission.
With us, you can get regulatory packages and services for lentiviral vectors that support you on your path to IND and market approvals, including cross reference letters for Biologics Master Files (BMF) with US Food & Drug Administration (FDA) and Health Canada. For regions without an equivalent BMF mechanism, we prepare additional documents such as Regulatory Support Files (RSFs) to support your regulatory submissions.
Meeting Chemistry, Manufacturing and Controls (CMC) requirements is essential for a successful regulatory submission. Our cell therapy manufacturing platform, including process components, are supported by Master Files to meet CMC requirements. Part of the Master Files are complete process mappings and descriptions, as well as protocols and reports for process qualification, assay qualification, aseptic process qualification, and storage and stability reports. Outside the US, Canada and Japan – in countries were no Master File System exists – Miltenyi has established Product Information File (PIF) systems for all raw materials for the manufacturing of CGT products. PIFs are a concise regulatory summary (CMC) of non-confidential information to support your clinical trial submission. For your marketing authorization, we support you with Regulatory Support Files (RSFs: confidential information) to finalize your submission.
For the manufacture of your cell therapy product, most raw materials are part of the MACS GMP Portfolio. MACS GMP Products are manufactured and tested under a quality management system (ISO 13485) and comply with the relevant GMP guidelines. They are developed in accordance with USP <1043> on ancillary materials. Our product-specific documentation packages include information such as package inserts, lot-specific Product Quality Certificate (PQC), Product Information File (PIF) and/or Master File cross reference for select products, Certificates of Origin (CoO), or TSE/BSE statement. We work with you to ensure that all documents are in the right place and of the quality required for your successful exchange with regulatory authorities.