During INTERPHEX 2014, Pharmaceutical Processing will be sponsoring several Innovations Sessions on important industry topics:
Tuesday, March 18th
QbD Based Process Development Strategies for Antibodies
Speaker: Kumar Dhanasekharan, Director, Process Development, Cook Pharmica
Althought QbD principles are well established, their application to biologics process development is still not common. This presentation will outline how these principles can be applied in early phase development in practically viable ways to benefit late stage development and tech. transfer to manufacturing. The presentation will include discussion on scale-up approaches for both upstream and downstream development such as high-throughput approaches, platform based methods and traditional approaches to optimize productivity/ yield while maintaining product quality.
- Outline QbD Principles
- Process Development Methods for Antibodies
- Science based approach to process development
Innovation Stage 3 1:30 PM – 2:30 PM
5 Rules for Sensor Placement in GMP Temperature Mapping
Speaker: Paul Daniel, Senior Regulatory Compliance Expert, Vaisala
New regulations (China, India, Europe, USA…) are increasing the reach of GDP for Cold Chain, causing more companies to come under regulatory scrutiny. This is a new experience for many of these companies. For many of these companies, rising to meet this challenge means learning how to do temperature mapping. New guidance has been coming forth clarifying how to temperature map, with specific focus on mapping sensor placement and mapping techniques. I have taken this guidance, and recent experiences in Asia trying to teach sensor placement across language barriers, and consolidated sensor placement into a few simple rules to make proper sensor placement easy to understand and implement for those new to mapping.
- Briefly review the global regulatory changes in GDP to appreciate the massive increase in scope.
- Present “5 Rules” for easy and consistent sensor placement for temperature mapping.
- Show how the “5 Rules” are consistent with recent guidance from ISPE, PDA, USP.
Innovation Stage 3 2:45pm – 3:45pm
Current Capsule Filling Techniques Utiliizing Xcelodose Technology
Speaker: Theodore Koontz, VP, Operations, Xcelience, LLC
Innovation Stage 3 4:00pm – 5:00pm
Wednesday March 19th
Back To Basics: Tablet Design And Common Tooling Options
Speakers: Dale Natoli, President of Natoli Engineering Company, Inc. and Bill Turner, Technical Service Manager Tooling and Tablets
This session will discuss tablet compression tooling options.
Learning objectives for this session:
• Introduction to the basics of tablet design
• How to eliminate common tableting issues, including multiple tip tooling configurations.
Innovation Stage 3 10:30am – 11:30am
Integration of Controlled Nucleation Technology into a GMP Lyophilizer
Speaker: Joseph Brower, Technology Manager, IMA Life
Controlling the process of ice nucleation within a freeze dryer has been shown to improve process control, shorten cycle time, and improve finished product attributes. This has been demonstrated in the laboratory for years, but is just now becoming available at commercial scale. VERISEQ Nucleation Technology is now being installed on commercial lyophilizers. This session will describe the VERISEQ Nucleation method of operation, provide some case study data, and highlight the challenges involved in introducing this technology into a GMP aseptic environment. Design considerations, integration approach, and testing methods will be discussed
- Introduction to controlled nucleation benefits in general
- Describe the VERISEQ Nucleation mode of operation
- Detail the challenges and solutions for integrating the technology ino GMP aseptic systems
Innovation Stage 3 11:45- AM – 12:45 PM
Overcoming The First Hurdle – Sample Prep
Speaker: Nikki Schopp, Team Leader, SGS Life Science Services
When analyzing for trace metals using Inductively Coupled Plasma (ICP), sample preparation is critical. The solubility of the test article is not the primary factor when choosing a sample preparation method. Just because a test article is water soluble does not mean that the direct aqueous solution method is the best choice. Four sample preparation methods are typically used when performing Elemental Impurities testing. Liquid samples may be analyzed neat and solid or liquid samples may be analyzed in aqueous or organic solutions, or digested in a closed-vessel apparatus. The blank and standard solutions should be prepared in the same matrix as the sample, using the same solvent, acid concentration and stabilizers. Spike recovery studies will ensure the method is accurate, specific and precise when used as a quantitative method.
· ·Understanding the importance of sample prep in applying USP 233
· ·Looking at each sample on a case by case basis
· ·Where the USP is at currently on 233
Innovation Stage 3 1:30pm – 2:30pm
Thursday, March 20th
Single-Use Pumps Take Center Stage
Speakers: David Kirk, Hygienic Market Manager, Pump Solutions Group and Dr. Andreas Frerix, Applications Manager Biotech/Biopharma, Pump Solutions Group
In the global pharmaceutical industry, increased emphasis is being placed on the manufacture of advanced biologically derived drugs. These biologics offer exciting potential for the development of blockbuster drugs that can provide treatments for a wide array of diseases. However, there are speed-to-market challenges for manufacturers who wish to optimize the commercial window that these drugs possess. An exciting new technology is now available that meets these speed-to-market challenges: single-use four-piston (quaternary) diaphragm pumps. Single-use pumps feature replaceable heads that enable biopharmaceutical manufacturers to optimize the cost of cleaning and validating their production systems. This creates a quicker production process, as well as one that delivers the required levels of product purity and sterility with no harm to the product and no chance for costly cross-batch or cross-product contamination.
- How advancements in equipment can help the public and improve manufacturer’s ROI
- How single-use pumps help manufacturers satisfy objectives of pure product creation and optimized commercial windows
- Detailed look at single-use quaternary pumps and other technologies in specific applications.
Innovation Stage 2 10:30am – 11:30am
Advanced Aseptic Processing To Reduce Risk With Sterile Fill/Finish
Speaker: Bill Hartzel, Director of Strategic Execution, Catalent
Recalls and warning letters litter the headlines on the manufacturing challenges of aseptic parenteral filling. These challenges manifest in the final container closure and can directly impact the safety of the patient. These challenges and issues are derived from the complexity in the preparation, handling, filling and sealing of the final container closures in the aseptic filling process. However, the use of advanced aseptic filling techniques that are used in blow/fill/seal technology can substantially reduce the leading causes of microbial and particulate contamination through the ability to control the critical parameters and by removing people from the process. The presentation will focus on how the principles of QbD are leveraged and can reduce the risk profile associated with aseptic manufacturing.
- Identify the Quality by Design elements of the BFS equipment
- Evaluate the risk mitigation properties of advanced aseptic properties
- Elevate the awareness of BFS Technology
Innovation Stage 2 11:45am – 12:45pm
For more information and to register – please visit: www.interphex.com/Register