Sep
30
2020
On demand

The multi-modal manufacturing movement - you don't need to know the future to be ready for it

Contract manufacturing organizations (CMOs) need the flexibility to respond to ever-evolving client needs. Likewise, manufacturers who are bringing their ATMP production activities in-house have complex product pipelines and need the flexibility to develop different modalities in parallel, unsure of which will ultimately go to market. Both are united by the same challenge: they need a facility that can accommodate a pipeline of four or five product types, each requiring a highly sensitive process.

But designing a bespoke production suite unique to each modality would lead to astronomical costs and a sprawling, inefficient facility. Why not fight cancer with an mAb product? Fight a pandemic with a vaccine platform? Do it all in the same manufacturing suite, weeks apart. Hypersonic speed-to-market, powered by a new breed of highly responsive multi-modal facility design is upon us.

Attendees will learn:

  • How to easily scale your facility as pipeline evolves
  • How to get up and running with industry-leading rapid deployment
  • How to protect investments with a flexible and adaptable facility
Peter Walters

Peter Walters

ATMP Conceptual Designer, CRB

Peter Walters is a process engineer with 15 years of experience specializing in pharmaceutical process and facility design. He has designed equipment and processes for the multi-step manufacturing of pharmaceutical drug products, performed scale up of aseptic bulk process to various capacities and product manufacturing for clinical studies in phases I, II and III. His experience includes the design, development and validation of clean-in-place and sanitize-in-place processes for aseptic bulk production systems. Peter has extensive experience with CGMP manufacturing, including generation of procedures and batch records, validation of systems and processes and the manufacture of clinical and commercial products.

Noel Maestre, PE, LEED AP

Noel Maestre, PE, LEED AP

ATMP Director, CRB

Noel Maestre is a Biotech Core Team leader at CRB, with an emphasis on Advanced Therapy Medicinal Products (ATMPs). Noel comes from an extensive background in mechanical and process utilities engineering with experience in the life science industry. Noel specializes in the design, construction and startup of biotechnology, pharmaceutical and advanced technology facilities, and has emerged as a cell and gene therapy Subject Matter Expert. Maestre is experienced in traditional biotechnology/pharmaceutical facility design, including a concentration on single-use process systems, batch versus continuous process and emerging technologies, such as cell and gene therapy. His focus as a project manager is to provide the right solution for the specific problem—true turnkey delivery, lean concepts and innovative project execution are key goals when delivering projects. Maestre is a graduate of Pennsylvania State University with a Bachelor of Science in mechanical engineering.

SPEAKERS

Peter Walters
ATMP Conceptual Designer at CRB
Noel Maestre
Director, ATMP at CRB

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