Webinars

Thursday, April 8, 2021 / 1:00 PM EST

Inductively Coupled Plasma - Optical Emission Spectrometry (ICP-OES) and Inductively Coupled Plasma - Mass Spectrometry (ICP-MS) are widely applied in pharmaceutical analysis, including drug product analysis and medical device analysis. ICP-MS is commonly used for elemental impurities analysis and extractable/ leachable studies due to its high sensitivity. The evaluation of individual elements is based on USP 232 and ICH Q3D guidelines. Additional elements that are not included in the risk assessment per ICH Q3D can also be quantified. ICP-OES has been found to be a powerful tool in reverse engineering of a Reference Listed Drug (RLD). For those active pharmaceutical ingredients (APIs) containing metal elements, such as iron, zinc, arsenic, sodium, platinum, ICP-OES can be used to accurately quantitate these elements in the APIs and finished drug products.

• Introduction on ICP-OES and ICP-MS, their sameness and difference
• General Application of ICP-MS
• General Application of ICP-OES
• Sample Preparation for ICP analysis: Microwave digestion system, CEM MARS 6

Tuesday, March 30, 2021 | 1:00 PM EST

The classical approach to bioavailability enhancement of poorly water soluble drugs is through the use of solubility enhancers such as co-solvents, surfactants, and emulsifying agents. But depending on the rate limiting factors for drug absorption, simply increasing the API solubility may not have a significant impact on the bioavailability. There is an interplay between solubility and permeability that can be evaluated using In vitro flux/permeability testing. This can provide valuable insight into the potential factors limiting bioavailability, and should be characterized before choosing a bioavailability enhancing formulation approach. This approach can also be used to compare release and absorption of candidate formulations. 

In this webinar we will discuss the use of in vitro flux and permeability as a tool in formulation development to:

• Evaluate/characterize the rate limiting factor(s) for passive diffusion of an API.
• Screen potential bioavailability enhancers for improvements to flux and permeability.
• Compare candidate formulations for potential bioavailability enhancement.

SPEAKER:

Travis Webb, MS Pharmaceutical Chemistry

Formulation Scientist, CoreRx, Inc.

WATCH NOW ON DEMAND

Are you wondering how to set up a stability test plan for your vial product?  Are you confused at all the options for Container Closure Integrity Testing and wondering how to decide which one to choose for your product?  Then join us for a webinar on Stability and CCI testing.  We will outline the basics for setting up a stability test plan for rigid containers including aging conditions and testing frequency.  We will look at how probabilistic methods differ from deterministic methods and will discuss each of the common CCI test options outlined in USP 1207.  We will conclude with CCI method validation basics.

Agenda:
 

• Stability Testing Basics
• Probabilistic vs. Deterministic Test Methods for CCIT
• Important Considerations for CCI Testing
• CCI Test Method Validation Basics

Presenter: 
 

Jennifer Gygi, B.S., SM(NRCM)
Expert Technical Consultant, Nelson Labs

• Acceleration of bench-to-bedside timelines in oncology
• Emergence of decentralized trials
• Impact of decentralized trials on regulatory pathways
• Real-world evidence’s influence on future trial design

• Bruce A. Feinberg, DO- VP of Clinical Affairs and Chief Medical Officer, Cardinal Health Specialty Solutions
• Todd Phillips, PharmD– Director of Regulatory Affairs, Cardinal Health Regulatory Sciences
• Scott Swain, PhD, MPH– Director of Real-World Evidence and Regulatory, Cardinal Health Specialty Solutions

WATCH NOW ON DEMAND

Univercells Technologies has been working to leverage deep expertise in bioprocessing and equipment development to revolutionize virus manufacturing for gene therapy and vaccine production. By combining the principles of intensification and chaining, the company has introduced the NevoLine™ Upstream platform, a fully automated and integrated biomanufacturing unit designed to enable commercial scale capacity in a compact module. 

Directly from its development site in Belgium, Univercells Technologies is inviting you to join the virtual product launch of this breakthrough technology. The event will highlight the features of the NevoLine Upstream platform, including an explanation of the main benefits and key performance data. Attendees will see how users of the NevoLine Upstream platform can increase viral productivity while benefiting from a flexible process approach in a reduced footprint.

The event will offer: 
 

• A review of the principles of intensification and chaining and how they directly influence viral performance, manufacturing footprint, and overall costs
• A demonstration of how the NevoLine Upstream platform enables commercial upstream and midstream GMP manufacturing in a 3m2 (~32 ft2) footprint
• A look at how the design of the NevoLine Upstream platform aligns flexibility and productivity to accommodate various process configurations
• A comparison of footprint, Capital Expenditure, and Cost of Goods gains using the NevoLine Upstream platform versus conventional technologies

WATCH NOW ON-DEMAND

Learning Objectives

• Discover a new implementation of packaging for the safe transport of high potency and/or sterile ingredients between DS production and DP formulation facilities. 
• Learn how disposable containment technology can change the status quo and provide additional benefits to both CMO’s and end-users / product owners alike.
• Gain insight in to how these technologies have been validated to meet the needs of primary packaging, sterility assurance and powder containment.

Who is it for:

• Pharmaceutical companies with CMO partners looking to deploy faster off the shelf solutions that can be utilised throughout their in-house and extended networks.
• CMO’s and ingredients manufacturers looking for standardised packaging formats that add value and to their products and improve their customers convenience from goods receipt to processing methodologies.
• Supply chain partners responsible for managing CMO partnership and the associated value chain for receiving product.
• Packaging Engineers looking to discover and implement new packaging formats that can benefit their companies’ operations.
• Process and production Engineers who need to solve powder containment challenges during transfer to and handling within the production facility.
• Quality and Validation Engineers looking to solve sterility assurance challenges associated with packaging of product for storage and transportation and the transfer of powders for aseptic filling.

Speaker:
 

Ben Wylie

Senior Product Manager, ChargePoint Technology

• Approaches that may eliminate the need for dedicated production equipment and facilities, thus maintaining the benefits of outsourcing and efficiencies of scale.
• Advances in equipment and technology that will strengthen safety methods, while maintaining flexibility for multi-product plants.
• How the decisions CDMOs make today transform the way products in multi-product facilities will function together in the future.

• Steve Nole - Vice President, Operations, Grand River Aseptic Manufacturing
• Les Edwards, MSE - Vice President of Technology and Business Development, SKAN
• Andre Zdunczyk - Regional Business Development Director, USA, Bausch + Strobel

WATCH NOW ON-DEMAND

Are you developing a biologic, biosimilar, or other complex drug product requiring lyophilization? Register for this webinar from Lubrizol Life Science to explore key considerations in designing and executing aseptic process simulations for lyophilized products, including a deep dive into study design, operational considerations, and regulatory guidance. Learn how robust validation can lead to commercial manufacturing success.

Key Learning Objectives:

• Explore the growth of aseptic lyophilization for biologics and complex drug products
• Discuss validation requirements and regulatory guidance for aseptic manufacturing processes
• Explain aseptic process simulation (AKA media fill) design and execution for lyophilized products
• Investigate common challenges and solutions when performing aseptic lyophilization—including operational considerations and real-world examples
• Understand how a well-designed validation strategy enables efficient aseptic lyophilization for the long-term

Speakers:
 

Dr. Karen Bossert

Vice President of Operations, Lubrizol Life Science Health – CDMO Division

Judy Cohen

Vice President, Quality Assurance, Lubrizol Life Science Health – CDMO Division

WATCH NOW ON-DEMAND

Piramal Pharma Solutions will present data from a simple OFAT experiment varying TCEP:mAb ratio to highlight the variability in distribution of species in some key assays supporting critical quality attributes of an Antibody Drug Conjugate. Piramal will discuss how this experiment can support product and process knowledge during product development (both early and late phase). We will aim to show how a small number of experiments can generate a large amount of data that is valuable to clients at key points during product development.
 

Speaker:

Allan Davidson

Head of Department, Analytical Development, Piramal Pharma Solutions 

• Examine the goal and science of sterility assurance including the revision of AAMI ST67
• Introduce and contrast Terminal Sterilization and Aseptic Processing of drug products through a regulatory lens as well as that of a manufacturer
• Discuss modification strategies to consider in order to use Terminal Sterilization

Expediting development timeline is directly related to obtaining IND clearance and starting phase 1 study faster. This webinar describes how you can get to IND faster through our accelerated & high performance proprietary cell line, S-CHOice; Samsung Biologics presents 3-month cell line development timeline and high-quality cell line. In addition, we will present the combined benefit with S-CHOice and 2-step purification platform, which can further expedite the timeline as well as reduction in manufacturing costs. We hope to share how our Faster & Better approach can be applicable to your molecule's successful development path to IND. 

Speakers:
 

John Gill

Director of Cell Line Development 

Beomkyu Kim

Lead Scientist of Downstream Process Development

• About the opportunities to transform quality management 
• How the right technology streamlines global quality processes, increasing automation and operational agility
• The industry best practices for driving successful digital transformation

• Study Design – how to choose parameters that are representative of your facility while meeting regulatory expectations.
• Indications that initial or subsequent disinfectant efficacy testing needs to be performed.
• Interpretation of results – translating microorganism log reductions into useful information on the efficacy of facility cleaning procedures and disinfectants.