Embed Size (px)
Citation preview
PTM Consulting S.r.l. a socio unicoPiazza IV Novembre, 6 | 42049 S. Ilario d’Enza (RE) ItalyC.F./P.IVA: 02039750340 - REA 265267Tel: +39 0522-472812 | [email protected]
Micro-Sphere SAVia Cantonale, 77 | 6998 Monteggio, SwitzerlandTel: +41 91 986 70 70 | [email protected]
WHEN FACILITY
MEETS FACILITATION
Informed decisions for better processFounded in 2002, now leader in risk management solutions, PTM Consulting offers his expertise methodology and the experience across European life science market, in order to reach concrete goals such as desired quality target, costs and time minimization, waste reduction, knowledge management.
PTM Consulting provides solutions to improve and optimize business products and processes from the early stages of development to the industrial ones, achieving the desired quality targets, minimizing cost and time development through an efficient and effective project management.
PTM Consulting works for leading pharmaceutical companies in Europe and the United States by applying the concepts and principles of Quality and Design, Process Validation, Product Validation, Lean Manufacturing, Transfer of Technology, Quality Risk Management to the early and full development phases - up process, industrialization and life-cycle management.
PTM is leader for process optimization and development and offers several services concerning 4 main areas:· Integrated Quality Risk Management· Quality by Design· Technology Transfer Accelerator· Validation, Quality, Manufacturing Support
Your reliable partner for spray dryingMicro-Sphere is a Swiss based contract CDMO with specialist expertise in the field of spray drying and capsule filling of APIs and HPAPIs with confident knowledge in inhalation technology. Our current state of the art facility (construction finished in 2017) is specifically designed for spray drying and capsule filling enabling us to support our clients’ needs in pre-clinical, clinical and commercial phases, and tailor solutions to their requirements and timelines.
Micro-Sphere capabilities:· Spray Drying· Blending and Mixing· Capsule Filling· Analytical Services
SCENARIOA leading Italian pharmaceutical company developed a new inhalation product based on a high cost active ingredient using a customized spray-drying technique.
Successful & repeatable project approach thanks to:
- Shared project rules
- Project Management approach
- Decision making risk-based through S&G system
CASE STUDY
GOALS· Accurate study of the spray-drying and capsule filling phase to proceed with the development and registration of the product, experimental costs minimization.· Ensure product quality in terms of critical attributes.· Control and reduction of development time.
CUSTOMER REQUEST
Scale up from a Development Process to Commercial scale. Problem 1: SPRAY DRYING During spray-dying process it was necessary to keep humidity not more than 2% during product handling process. Problem 2: MIXINGMixing of components was difficult due to different particle size and particle density. Problem 3: CAPSULE FILLINGCapsule filling problems due to low drug content (≤ 2% of composition).
RESULTS
All the technical and methodological activities planned by PTM and Micro-Sphere enabled to:· Reduce the number of batches under development, in particular in phase 3 on semi-finished B (12.5% reduction), but also in the process validation phase.· Obtain an increased knowledge of the product and of the process while reducing production costs and time.· Perform a complete process validation.
TOOLS· Technology Transfer Accelerator (TTA) – PTM· Integrated Quality Risk Management (IQRM) – PTM· Design of Experiments (DoE) - PTM· Spray-drying technology – Micro-Sphere· Laboratory/Analytics equipment – Micro-Sphere
WHEN FACILITY
MEETS FACILITATION
Problem Solving
