Webinars

Microbiological testing is a critical component to ensuring the quality and safety of pharmaceutical products.  In addition to robust manufacturing processes and controls, an appropriate QC testing strategy can provide assurance that products are free of contaminants and are suitable for their intended use.  Compendial guidance (in some cases, harmonized across the USP, Ph. Eur., and JP) provides general instructions for testing based on validated methodology and long-established microbiological best practices.  However, the application of appropriate methods and techniques depends on various product attributes and quality requirements.  Understanding factors that contribute to method sensitivity and variability is important in generating consistent results and allowing meaningful data evaluation.

Discussion Points:

• Introduction to microbiological testing of raw materials, APIs, and finished products
• Validation of methods
  - Compendial chapters outline general parameters, techniques, and requirements
  - Method Suitability vs. Method Verification/Validation
• Product specifications and method sensitivity
  - USP/NF monographs and USP <1111> for raw materials, APIs, and finished products
  - Method variability and application of specifications       
•  General procedures to investigate unexpected results

• Learn the fundamentals of effective package design and production
• From safety measures to brand differentiation
• Leveraging technology to get the best results
• Understanding your sustainable alternatives and environmentally responsible sourcing

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Tribute must be paid to the hugely impressive efforts of those who reconfigured existing equipment at speed into a "Generation 1" manufacturing process for mRNA vaccines. However, it is unclear that this configuration is optimised to meet future needs.  Micropore will present its fully aseptic, low pressure technology to optimise the technology into a "Generation 2" configuration to improve overall efficiencies for the anticipated major growth in LNP technology as a delivery system for treatment of infectious diseases and cell & gene therapies for hereditary diseases.

In this webinar you will learn about:

• The equipment setup specifications and the parameters tested during experimentation by the team at Strathclyde
• Detailed findings and results from the head of head of Micropore’s Operations team
• The immediate application for pharmaceutical product manufacturing and the potential foreseen for further developments using this technology

Presenters:

• Dr Yvonne Perrie - Professor, Strathclyde Institute of Pharmacy & Biomedical Sciences, University of Strathclyde, Glasgow.
• Sam Trotter MSc - Operations Manager, Micropore Technologies Ltd
• Camden Cutright Ph.D. - Business Development Director, Micropore Technologies, North America

• The importance of flexibility and transparency
• Selecting the “right-sized” CDMO
• Strategies for reducing risk
• Best practices for project management
• Streamlining projects with a full-service CDMO

In the EMA newsletter published in September 2019, the pharma industry was given a wake-up call regarding the request to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients. This presentation will look at case studies of analytical testing in the three-step request to review the risk for presence of nitrosamines in medicinal products process issued by EMA/FDA.

• Nitrosamine testing of packaging materials found ‘at risk’ and ‘Fill the gap’ testing to support the paper-based Risk evaluation/assessment

• Analytical challenges for Confirmatory testing

• Routine testing as part of changes to the marketing authorization

Speakers:

• Ank Reumer - Senior Study Director, Quantitative Methods- Nelson Labs Europe

• Andrew Teasdale, PhD - Senior Principal Scientist Impurities Management Astra Zeneca

Although many aspects of integrated CQV programs could be covered by current policies, most organizations can benefit from additional program review and development. Including sufficient procedures and templates can streamline and enhance the process of document development, reviews/approvals, timing of inter-related activities, and overall CQV leveraging strategy.

An integrated CQV strategy can support current projects and ongoing operations. This webinar will cover integration strategies in several key areas, including:

1. General Validation Strategy Program Development
2. Validation Program Governance
3. Change Management Procedures
4. Additional Programs:

• CQV Organizational Structure and Resource Requirements
• CQV Communication Plan
• Schedule Logic Development
• CQV Execution Tracking Tools
• Cost Management
• CQV Issues Log, Submittal Log, and RFI Log
• Project Management and Project Controls Program Development

• Michael Bogan - President, ICQ Consultants
• Michael Gatta - Princiapl, ICQ Consultants

Avéma Pharma Solutions, a division of PL Developments (PLD), is in the unique position being both a consumer and supplier of global CDMO services for both OTC and rX products. In this webinar, we’ll explore the lessons we have learned from managing our own CMOs that have allowed us to build a better CDMO model for our Avéma customers. We’ll address the areas that can help speed up your time-to-market, keep development costs under control, and smooth the FDA approval and commercial launch process.

Over the years, PLD has used CMOs to augment our own in-house manufacturing to help support our Private Label business. But, after adding a book of products and business from our acquisition of TEVA’s store brands business in 2019 we were suddenly managing the more than thirty CMOs that supported TEVA’s needs. That process, plus our experience on-boarding new customers at Avéma, has given us empathy about the challenges and insights into what makes a good partnership. The webinar will cover what to look for in a CDMO, and how putting the right parameters in place at the beginning of a client-CDMO relationship, reduces risk and improves communications.

Some of the “pain points” addressed during the webinar, include:

• Preventing miscommunications and errors through a detailed RFQ process
• Reducing scale up errors by using small scale manufacturing instead of “bench top” equipment.
• Reducing cost and time by not having to rely on commercial size equipment “scaled down” to run pilot trials.
• Reducing lead time by doing most analytical and tech transfer with “in house” resources
• Keeping component costs down by drawing on the buying power and resources of a CDMO with an extensive network.
• Streamlining FDA approvals through QbD implementation.

• Jeffrey Speicher - Commercial General Manager, Avéma Pharma Solutions
• Dana Toops - President, Avéma Pharma Solutions

Scientists are the literal lifeblood of new product development and innovation, but they often spend much of their time simply pulling together data to conduct analysis in hopes of key learnings. The biggest lever that R&D leaders have today is to implement tools that make this learning process faster and easier, through better data tools. This Webinar will focus on the benefits of implementing a true data infrastructure, and the challenges that organizations will face along this journey.

• Identifying where on the digitalization journey your R&D organization is
• What is meant by "structured data capture"
• The steps necessary to implement a structured data solution successfully, and common pitfalls
• The short term and long term benefits of a truly connected R&D team

Whether you are an emerging CDMO looking to scale rapidly and attract sponsors or an established organization looking to transform your legacy quality manufacturing processes there is an approach to consider.

Join Veeva System’s Ashley Wentworth, Director of Quality Strategy and Glen DeGuzman, Solution Consultant, to learn how you can unify end-to-end quality management to improve visibility, efficiency, and compliance.

Why should I attend?

See how a unified cloud solution purpose-built for life sciences allows you to:

• Seamlessly connect processes, data, content, and training
• Improve on-site and remote audit responsiveness and readiness
• Securely collaborate with external customers, suppliers, and partners

Register to see how your organization can drive speed, collaboration, and GxP compliance.

Presenters:

• Ashley Wentworth - Director, Vault Quality, Veeva Systems
• Glen DeGuzman - Solutions Consultant, Veeva Systems

Join James Scull, Ph.D., Scientific Director for Element Life Sciences, for a live webinar to gain a deeper understanding of extractables and leachables (E&L) evaluations of custom drug delivery devices. Dr. Scull will present a case study that explores the E&L consideration of such custom delivery systems in order to meet regulatory requirements.

Why should I attend?

Dr. James Scull discusses extractables and leachables testing considerations for customized syringe delivery systems. His presentation will include:

• An overview of regulatory requirements for drug delivery systems
• Situations and types of drug delivery devices requiring custom E&L testing solutions
• When during the development journey such testing should occur
• Other factors to consider when determining when the E&L evaluation is necessary

Each phase of drug development encounters specific hurdles that require specialized expertise and advanced technologies to overcome and to ensure readiness for the next phase. A holistic approach to a program with cohesive program management can offer a dedicated focus to the intricacies of each phase and beyond. In this webinar, Catalent experts will explain how the phase appropriate expertise and technologies of the OneXpress™ Solution can help streamline development and manufacturing, speed up your program timelines, and reduce risks to transform your science into a successful treatment.

Key Takeaways:

• The nuances and complexities of early versus late stage development
• Top considerations for a robust formulation and manufacturing strategy
• The need for fully integrated CDMOs and the advantages of the OneXpress Solution

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

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.