INTERPHEX is pleased to announce its 2012-2013 Webinar Series. The Webinar Series aims to support INTERPHEX's robust conference program and will serve as the industry's year round education resource, covering the hottest topics and trends.
Upcoming Webinars
The Challenges and Opportunities in Converting an Existing Facility to a Hybrid or a Single Use Facility
Date: June 6, 2013
Time: 2:00pm-3:00pm EST (-5 GMT)
Speaker: Roman Rodriguez, Mobius Group Global Manager, EMD Millipore
Converting all or part of an existing facility to single use technologies can be dictated by a diverse yet intertwined set of parameters that are technical, strategic and administrative. Additional parameters will impact the decision including personnel, schedule, current facility design, existing equipment, product comparability, and inventory control management.
This presentation will assist with the decision making process by highlighting the key considerations for each of these parameters.
By participating in this webinar, you will:
- Learn about the evolution of the Biotech market
- Understand Single-use technologies
- Review the opportunities and challenges around an Hybrid or Single-Use solution
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Now
Webinar Archive
Listen to recordings of past webinars from INTERPHEX's 2012-2013 Webinar Series. The Webinar Series aims to support INTERPHEX's robust conference program and will serve as the industry's year round education resource, covering the hottest topics and trends.
FAST DoE by Means of Continuous Technologies
Date: Thursday, May 23, 2013
Speakers:
Andrew Birkmire, Process Development Manager, GEA Process Engineering Inc.
Kris Schoeters, Product Manager Continuous Processing, GEA Pharma Systems
Richard Steiner, Business Development Manager Continuous Processing, GEA Pharma Systems
Design of Experiments describes a set of controlled investigations that have been designed to evaluate process variations. Even a simple DoE is comprised of several trials, which can be time-consuming when working with the traditional batch systems.
This presentation describes a number of case studies which clearly show that using continuous technologies, the time of executing a DoE is significantly decreased.
The equipment used for the case studies is a ConsiGma™-1, the R&D version of the continuous wet granulation and drying system by GEA Pharma Systems.
The case studies described cover amongst others the influence of API properties on final product characteristics, tuning of release profiles by changing the ratio of the ingredients of a formulation, high drug load applications and melt granulation processes.
By means of these case studies, also other benefits of continuous technologies and the use of DoE will be highlighted, such as the possibility to establish a sound, scientifically-based Pat strategy that only measures those parameters that have an impact on the critical quality attributes.
- DOE to increase process knowledge and set up PAT strategy
- Continuous technologies decrease Time to market & Cost
- Continuous technologies & DOE provide increased end quality
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Equipment Considerations for Continuous Dry Granulation
Date: Thursday, April 11, 2013
Speaker: Dejan Djuric, PhD, Manager of Scientific Operations, L.B. Bohle Maschinen + Verfahren GmbH
Continuous dry granulation has been an established process in the pharmaceutical industry for decades. New technology innovations in granulating equipment give pharmaceutical manufacturers more high-efficiency options.
Today, dry granulation is often the process of choice for large-volume or temperature and moisture-sensitive pharmaceutical products because of its high-production capacity and minimal material loss.
In comparison with traditional wet granulation techniques, a sophisticated drying system is not necessary. This avoids large investments for production equipment and space, lowering manufacturing costs. The compaction process with fast rollers is also applicable for high material throughputs, enabling the production of different products and batch sizes with a single machine. This can be achieved through fast and precise control of the compaction force with a new electromechanical spindle drive for the two rollers.
New dry granulator equipment with electromechanical roller drives and massive roller shafts significantly reduces the time needed to achieve steady state during process start up, and parallel gap is assured throughout production. With a variety of different sieve types for different product and ribbon properties, dry granulation assures a wide production range, achieving desired particle size distribution.
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Designing Critical Cleaning Processes to Mitigate Microbial Risk in Multiproduct Facilities
Date: Wednesday, March 6, 2013
Speaker: Paul Lopolito, Technical Services Manager, Life Sciences Division, STERIS Corporation
Speaker: Mary Ellen Clark, Validation Scientist II, MedImmune
Microbial contamination of process equipment is a concern for pharmaceutical, biopharmaceutical, medical device, dietary ingredients and personal care industries. Microbial contamination can lead to costly delays and is specifically challenging for multiproduct facilities. Designing critical cleaning processes used during product change-over is an important step in any contamination control risk-based strategy.
This presentation will focus on three critical elements. The first element is a review of the different types of microbes and the microbial efficacy of alkali cleaning agents. The different microbes include vegetative bacteria, endospores, mycobacteria, mycoplasma, fungi, viruses and prions. The second element is a review of the surface and equipment design. Surface and design issues may include materials of construction, rouge, length and orientation of dead legs, slope of piping, crevices and drainability. The third element is defining the critical cleaning parameters to ensure effective product and process residue removal.
A simplified laboratory screening process will be discussed along with specific examples on how information generated from these studies can be used to develop effective cleaning strategies. This presentation will also include a case study to help assess and mitigate risk of microbial cross-contamination from one batch or product to another.
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Handout
Scale Up-Scale Out: Challenges in OSD Processing
Date: Friday, December 14, 2012
In the current environment the pharmaceutical technologist is faced with an ever changing series of regulations, difficult drug substances and the time pressure to make market entry and reach maximum product potential quickly. For many drug substance candidates their inherent physicochemical and pharmacokinetic properties pose unique challenges necessitating application of advanced solid dosage form technologies. The same is true for innovators as well as generic firms that being the manufacture of bioavailable products which are seamlessly reviewed and reach the market quickly. Imbedded in this technical tapestry is the inevitable question of how large a batch needs to be or more fundamentally 'what scale do I need to achieve'. In many cases the need for scale-up and the effort to achieve this are looked at as a major technical challenge.
Led by industry experts, alternatives will be provided to this aspect by considering the risk in scale-up as opposed to the concept of scaling-out using a batch process which is more aligned with that of a 'pilot scale'. How to manage the perception that scale-up may be replaced with scale-out using more efficient processing scenarios that have an inherently lower degree of risk when looked at against the back drop of developing larger less flexible process scenarios. It is our objective to provide some insight when the question of 'what scale' is asked.
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Looking into the Crystal Ball: The Drivers and Attributes of the Biomanufacturing Facility of the Future
Date: Thursday, Nov. 1, 2012
A lot is being discussed and written about what biopharmaceutical manufacturing facilities of the future will look like, how they will operate, and what is driving companies to move outside their "comfort zone" to develop new design approaches and concepts. There are a number of approaches that are being discussed; some have varying approaches to address business and regulatory requirements.
Executives from Nanotherapeutics and Subject Matter Experts from IPS will provide their thoughts and vision on the impact of business climate, technology, regulatory philosophy, and operational approach in shaping the next generation facility model.
The webinar will touch on the following topics:
- Business drivers for current and new product platforms
- Emerging business models
- Enabling technologies
- Risk impact on process and facility design
- Process closure analysis
- Segregation impact on manufacturing environments
- Facility delivery models
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Now
Paul Lopolito
Technical Services Manager, Life Sciences Division, STERIS Corporation
Paul Lopolito is a technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to process research cleaners and contamination control, which includes field support, site audits, training presentations and educational seminars. Paul has over 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events including INTERPHEX, PDA, ISPE, ACHEMA, AALAS, and IVT. Paul has published several articles and book-chapters related to cleaning and cleaning validation. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.
Mary Ellen Clark
Validation Scientist II, MedImmune
Mary Ellen Clark is a Validation Scientist at the Frederick Manufacturing Center of MedImmune (Frederick, MD). She currently supports many aspects of validation activities, primarily focusing on cleaning validation. Mary Ellen has over 13 years of biotechnology experience and has held several positions within the organization including upstream and downstream manufacturing process operations. Mary Ellen has been an active member of the BPOG Multi-Product Workstream and recently co-authored an article in the Journal of Validation Technology focused on product inactivation during cleaning. She earned a B.S. in Animal Science from the University of Maryland College Park and a M.S. in Biotechnology Management from University of Maryland University College Campus.
Dejan Djuric
PhD, Manager of Scientific Operations, L.B. Bohle Maschinen + Verfahren GmbH
Dejan Djuric, Ph.D., has been the manager of scientific operations at L.B. Bohle since 2011. Prior to joining the company, he worked as an engineer in galenical development at Abbott GmbH&Co. KG, as well as a laboratory manager in global research and development of pharmaceutical excipients at BASF SE where he searched for innovative polymeric excipients. During his doctoral studies at the Institute for Phamaceutics and Biopharmaceutics in Dusseldorf, Germany, he worked on continuous wet granulation with a twin-screw extruder.
Andrew Birkmire
Process Development Manager, GEA Process Engineering Inc.
Andrew Birkmire is the Pharmaceutical Process Development Manager for GEA Process Engineering, Inc., the world leader in continuous powder processing. His current focus is on continuous processing for the Pharmaceutical Industry and the integration of PAT. He is the PAT Coordinator for GEA North America and currently is in charge of the Pharmaceutical Technology Center in Columbia, MD.
Kris Schoeters
Product Manager Continuous Processing, GEA Pharma Systems
Mr. Kris Schoeters holds a degree in Chemical Engineering , with a specialization in polymer-technology. He started his career as a R&D Project Engineer at Helvoet Pharma , a worldwide manufacturer of rubber closures and aluminium/plastic caps for pharmaceutical packaging, drug delivery and diagnostics. He later joined the Product Development Department of Janssen Pharmaceutica in Beerse Belgium (part of Johnson & Johnson) where he was involved in the design-concepts of a high containment plant for solid dosage formulations. He was overall responsible for the selection, installation and commissioning of new ( high contained) equipment and material handling systems for the solid dosage R&D and pilot plant. He joined GEA Pharma Systems Collette™ in 2001 ,and served in different positions including Project Management, Validation and Technical Sales Support. In his current role, Kris is head of the Process Development Center and responsible for the new Continuous Processing Technology as a Product Manager.
Richard Steiner
Business Development Manager Continuous Processing, GEA Pharma Systems
Mr. Richard Steiner holds a degree in Mechanical Engineering, a Master in B2B Marketing and a Master in Finance & Business Administration. He started his career as Process Engineer at Staedler Mars GmbH, a worldwide recognized Pencil producer. After that he joined the Extrusion technology department of Leistritz AG and served different positions from Sales, the Head of Strategic Marketing & Controlling, to the Head of BU Pharma-Extrusion. After that he was Director of the BU Extrusion & Tubing at RAUMEDIC AG, a manufacturer for Medical Devices. His current role, after joining GEA Pharma Systems in 2011, is the Business Development Manager for the Continuous Manufacturing Systems for Pharmaceutical OSD Products.
Roman Rodriguez
Mobius Group Global Manager, EMD Millipore
Roman Rodriguez is the Global Group manager for Mobius for EMD Millipore, located in Bedford, MA. He manages a team of product managers that are responsible for developing new single-use technologies such as Mixers or connectors.
Roman has more than 12 years’ experience in the single-use world as he held several functions in sales, marketing and product development in Single-Use. He has been able to follow the evolution of the single-use technologies and the market by interacting with end-users and overcoming new challenges around implementation and process optimization.
