History
PL Consulting was founded in 2007 by Peter Levy to provide consulting services to the Pharmaceutical and Biopharmaceutical industries. Since its inception, PL Consulting has successfully provided technical and management services to large and small Pharmaceutical and Biopharmaceutical companies in the US and Europe.
Prior to the establishment of PL Consulting, Mr. Levy (Principal and Sole Proprietor) worked in the Pharmaceutical Industry for almost 30 years -- primarily in the areas of Process Development, Process Equipment and Plant Design, Validation, and Manufacturing. His previous employment includes senior level technical and management positions at large (Biogen), mid-sized (Millennium Pharmaceuticals), and small (Altus Pharmaceuticals) biopharmaceutical companies as well as technical positions at an equipment supplier (Amicon Division of WR Grace) and a consulting engineering company (Dynatech R&D Company). Mr. Levy's formal training is in Chemistry and Chemical Engineering.
Experience
Manufacturing Management & Oversight
- Primary role as sponsor's agent at Contract Manufacturing Organizations (CMOs) in U.S., Europe, and Asia for clinical and commercial production.
- Assessment and management of CMOs for drug substance (API) and drug product (final dosage form) manufacturing.
Equipment & Process Validation
- Development and management of validation systems at a major Biopharmaceutical company.
- Design and implementation of the process validation system at a major Biopharmaceutical company.
- Publication of validation guidelines and participation in forums with other industry leaders.
- Experience in validation and preparation of validation summaries for multiple, successful U.S. (FDA) and European (EMEA) biologics license applications.
Equipment Development, Procurement & Fabrication
- Over 25 years' experience in the development of custom pharmaceutical manufacturing equipment.
- Oversight of development, design, and fabrication of dozens of custom manufacturing systems for large and small biotechnology companies.
- Downstream processing equipment (Tangential Flow Filtration, Normal Flow Filtration, Chromatography, Virus Filtration Systems).
- Specialized Equipment (Sterile systems for production of non-filterable parental drug products).
- Start-up and validation of specialized process equipment for Biopharmaceutical applications.
Process (Technology) Transfer
- Lead role in transfer of all types of production processes and unit operations at large and small Pharmaceutical and Biopharmaceutical companies.
- Successful transfer of dozens of Biopharmaceutical drug substance processes (mammalian cell culture, microbial, upstream/downstream, scale from 1000 to 20000 liters) at all phases of development (Clinical Phase 1 through Commercial).
Process Development
- Over 30 years' experience including technical leadership positions at major Biopharmaceutical companies and a major equipment supplier.
- Extensive expertise in filtration operations, downstream process scale-up, fill/finish operations, development and implementation of novel processes.
- Major contributions to five processes currently used to manufacture commercial products.
Project and Technical Management
- Successful record of project planning and execution in the Biopharmaceutical and process equipment industries.
- Leadership positions on CMC (Chemistry, Manufacturing, and Controls), equipment development, facilities build-out, and process technical transfer/manufacturing project teams.
- Experienced in the establishment and direction of effective Process Development and Process Engineering groups at large and small Biopharmaceutical companies.
- Development of detailed manufacturing cost models as well as general cost estimates for Biopharmaceutical processes and projects.
Project Planning and Budgeting
- Planning and budgeting experience on successful projects (Biomanufacturing plant build-out and start-up; custom equipment design, fabrication, start-up, and validation; unit operation process development for clinical and commercial production).
Process Development Staffing and Organizational Design
- Impressive record of building capable Process Development groups at multiple Biopharmaceutical companies.
- Direct experience developing processes for clinical and commercial Biopharmaceutical products.
- Development of processes used in at least five commercial Biopharmaceutical products.
Manufacturing and Development Due Diligence Reviews
- Experienced in review of processes and equipment used for product manufacture in support of product purchase or process transfer.
Infrastructure Development
- Assistance to small and moderate sized companies in the establishment of Process Development and/or Validation systems and departments.
- Infrastructure development activities include determination and description of key personnel positions; assistance screening and interviewing candidates; establishment of internal systems (report archiving, validation); development of internal guidance documents and SOPs.
Training Provided for Groups or Individuals
- Ultrafiltration training and workshops.
- Process Validation and Process Characterization training and presentations.
