- Developing a manufacturing strategy for BRIC(K)* Countries requires careful consideration of “Everything” (that can impact the size of the local plant and required capacity output over time)
- For example, modular expansion is tremendously important for profitability while automation is a major protection of company’s profit.
- Challenges are cost pressures, limited biotech exposure of local regulators, developing infra-structure, and inexperienced plant operations work-force.
- A SmartFactory is an enabeler of modern and cost effective manufacturing strategies efficiently mitigating those challenges.
*Brazil, Russia, India, China (and Korea)
Philipp Hess PhDFounder and Managing PartnerPHA - Philipp Hess Associates
- Process and quality data stored in systems like Paper Records, LIMS, LES, EBR, ELN, Historians, ERP, etc., is organized differently in each system to serve the needs of specialized users who focus on different portions of pharmaceutical production processes
- This creates problems for Quality and Process users who need to perform process monitoring, data analysis and reporting on the process as a whole, to understand the sources of variability through initiatives like Quality by Design (QbD).
- It also presents needless barriers to identifying Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA’s) for implementation of automated process monitoring with alerts review-by-exception as part of Continued Process Verification (CPV) initiatives.
- These users need an automated way to access, aggregate and contextualize all types of process-related data in a validated environment for analysis and reporting without resorting to labor intensive, error prone spreadsheet methods. This includes all types of process and quality data, including on-line data from real time (PAT) instruments.
- This presentation will describe how pharmaceutical companies have overcome these problems by using a Process Production Operations solution that provides a validated environment for self-service, on-demand access and automated contextualization of data located in disparate source systems without requiring any alterations to the change-controlled sources systems.
Justin O. Neway, Ph.D.Vice President and General Manager, Operations Intelligence Senior Fellow, BIOVIA Science CouncilBIOVIA, a Dassault Systèmes brand
For commercial lot release activities
Risk based approach (methodology driven by statistical analysis) taken to evaluate the current state of assay performance (analytical system for stability and capability) for the methods which continue to be used for product release
An effective approach to support:
- Continuous Quality Verification (CQV)
- Establishing and maintaining a State of Control (Analytical Methods)
- Facilitate Continual Improvement opportunities
Hemant Kumar PhDSenior Director, Corporate Quality Operations/Quality Sciences and Analytical TechnologyGenzyme
- Single sourcing in the field of biotech manufacturing requires a layered approach per material type/usage. Typical material clusters are:
- Alternatives not desirable or extremely challenging to qualify (e.g., suppliers of process-specific/unique materials, e.g. chromatography resins)
- No alternatives pursued (e.g., feasibility of safety stock such as low $/quantity, strong supplier relationship)
- Secondary alternatives available to be qualified (e.g., for high $, high quantity materials, volatility of supply market)
- Risk mitigation approach to be developed per (Quality and Regulatory) risk profile:
- Nature of raw material in question and complexity of market (e.g. customization)
- Where it is used in the process (criticality of process step)
- Regulatory considerations
- Case study: cell culture dry media powder supplier and material qualification program
Yuval Shimoni Principle EngineerBayer