The manufacture of parenteral pharmaceuticals is a high stakes endeavor. Any product imperfections, whether chemical or biologic, are equally as bioavailable as the active ingredients. Patient safety and product quality are paramount in pharemaceutical manufacturing. As a result, the utilization of isoloator technology has played an increasingly vital role in improving parenteral manufacturing control.
Isolators are a highly specialized and effective technology designed for the manufacture of sterile injectable products. They allow for the greatest sterility assurance, product quality, and protection for the manufacturing staff. Isolators mitigate the most significant risk of manufacturing parenterals, human intervention.
We will examine the latest developments in isolator technology, practical applications and benefits in sterile manufacturing, as well as explore important considerations in selecting a parenteral manufacturer, particularly for manufacturing potent and complex formulations.
Presented by
Adrian Raiche,
Director R&D, Piramal Pharma Solutions
Experience: 15+ years
Expertise: Formulation development and manufacturing, including lyophilisation and nanoparticle
Adrian Raiche earned his bachelor’s degree in chemical engineering at UK before joining Dr. David Puleo’s Biomaterials Lab in the Center for Biomedical Engineering, where he received his Ph.D. in 2003. While in the CBME, Adrian focused his work on releasing osteotropic biomolecules from resorbable biomaterials to promote healing at the tissue/implant interface.
Adrian applied his experience with pharmaceutical therapies at Bausch + Lomb, where he developed drug delivery therapies for ocular diseases through a small pipeline incubator research group. From there, he transitioned to Brookwood Pharmaceuticals in Birmingham, Ala., guiding sustained release biodegradable polymer development projects from initiation into clinical trials. One particular instance focused on developing a delivery system for nimodipine microparticles for treatment of vasospasm following aneurysm repair.
During this time, Adrian served as chair of the Ocular Drug Delivery and Disposition Focus Group and organized several sessions at conferences, including one at the joint FIA/AAPS International Conference on innovating products to meet the needs of developing and developed countries. Currently, Adrian is part of Piramal Pharma Solutions’s Lexington facility at (earlier Coldstream Labs) and focuses on contract and innovator development of nasal spray delivery products.
Brian Lihou,
VP - Project Management
Brian has in-depth experience with aseptic processing equipment trains, freeze drying bulk, and sterile filling applications, including vial and ampule filling of suspensions, proteins, and powders. He has also managed support groups such as Technical Support, Instrumentation, and Maintenance.
He has spearheaded performance improvement measures across departments and the optimization of plant procedure revisions and lot failure investigations for both clinical and commercial operations.
Brian has participated in many domestic and international Regulatory inspections in support of Manufacturing Operations. Brian has held positions in managing new facility start up, existing facility expansion, and new product launch campaigns on a variety of scales for both clinical and marketed commercial products. Brian received a B.S. in Management from Almeda University.
Brian has held positions of increasing responsibility at Endo Pharmaceuticals, Skyepharma Inc. (formerly DepoTech), Alkermes Inc., Genentech Inc., The Liposome Company, and Johnson & Johnson (Ortho Biotech).
James Drinkwater,
Head of Aseptic Processing Technologies & GMP compliance
Qualified Pharmaceutical process engineer with additional education in pharmaceutical microbiology. Head of F Ziel Laboratory support services.
Subject Matter Expert (SME) in Barrier Separation Technology: Isolators and RABS: Restricted Access Barrier Systems supporting process design.
Subject Matter Expert (SME) in vaporized hydrogen peroxide biodecontamination technology. F Ziel principle consultant.
10 years working directly in Pharmaceutical industry (GE Healthcare) Technical Director of 3 Barrier technology companies.
Technical and process Director of bio-decontamination (VHP) company.
Book chapter author, peer reviewed published articles in risk based environmental control and monitoring.
Chairman of PHSS: Pharmaceutical & Healthcare Sciences Society and leader of the PHSS Bio-contamination special interest group.
Active member of PDA, ISPE: international conference speaker.
