Biopharma CMC Consulting- From Sequence to Registration
Biopharma CMC Consulting- From Sequence to Registration
About Me- Matt Reeser, Prinicipal
My career spans a start at a cell culture bench in 2003 through four companies (a CRO, a large pharma, and two tiny biopharmas), over a dozen clinical introductions, three process validations, and several licensures. I have worked in a technical program management role through much of this time, and have gained innumerable experiences through the entire span of CMC process development and validation for a diverse set of products. I have a passion for solving problems- technical, quality, regulatory, timeline, and third-party related- and delivering stepwise team success.
Full CV and references upon request
My Core Services
Program Management
Program Management
Program Management
I offer everything you need for a CDMO-driven CMC program- vendor, timeline, contract, and team management. I have worked with dozens of major organizations across three continents.
Early CMC Services
Program Management
Program Management
I can bring you from sequence to cell line, into early process / analytical development, and through your first cGMP batch to keep your initial IND on track. I can help with RFPs and vendor selection as well, for both drug substance and drug product.
Regulatory Writing
Program Management
Regulatory Writing
I can write entire initial INDs (Module 3) and have extensive experience in BLAs for many SME areas as well. I can assist with CMC regulatory strategy and have sat through many agency reviews and IRs.
SME Services
CMC Scaleup and Tech Transfer
Regulatory Writing
I have specific expertise in mammalian cell line development and cell banking/characterization, and I have a large network of connections in all other relevant CMC fields for consultation.
CMC Scaleup and Tech Transfer
CMC Scaleup and Tech Transfer
CMC Scaleup and Tech Transfer
I have significant experience with scaleups, tech transfers, and process changes- including supporting comparability studies and ensuing regulatory amendment filings.
Systems Development
CMC Scaleup and Tech Transfer
CMC Scaleup and Tech Transfer
If needed, I can write technical documents including memos, risk assessments, SOPs, policies, and reports and work closely with your quality organization to develop robust systems. Review and audit services are available, including travel to third parties.