Webinars

Droplet Digital PCR (ddPCR) for Sensitive Testing in Advanced Therapy Manufacturing

Rigorous testing is integral to the development of a novel cell or gene therapy to ensure safety and efficacy of each product. When developing gene therapy products or manufacturing the product itself, accurate quantification of recombinant AAV or lentivirus is crucial, for example to accurately discern final vector titer, or to detect the presence of unwanted replication competent AAV/lentivirus (RCAAV/RCL), helping ensure the safety of new therapies.

One of the techniques WuXi Advanced Therapies is using for such characterization is droplet digital PCR (ddPCR). Compared with qPCR, ddPCR offers increased sensitivity and precision and removal of PCR bias by measuring the result of thousands of reactions (droplets) for each well. Since signal is measured after PCR cycling (endpoint PCR), error in quantification due to changes in PCR efficiency between or within runs is prevented. No standard curve is required; absolute quantification is achieved by comparing the number of positive droplets versus the volume of sample tested.

WuXi Advanced Therapies has optimized the ddPCR protocol, using the latest Bio-Rad equipment, as part of our advanced therapies testing arsenal. Incorporating automation into the process has minimized method variability and processing time, so that plate setup and method performance are similar in effort and complexity to traditional qPCR. Removal of a requirement for a standard curve simplifies the assay further, saving time and resources and eliminating any inconsistencies due to incorrect reference selection or amplification errors.  WuXi Advanced Therapies have expertise in utilizing ddPCR for assays requiring high precision within cell and gene therapy testing, such as viral titer assays.

WuXi Advanced Therapies integrates testing throughout the AAV manufacturing process and offers ddPCR under Good Manufacturing Practice (GMP) standards with several off-the-shelf targets, and as part of in-process and lot release testing. Further, WuXi Advanced Therapies as a Contract Testing Development and Manufacturing Organization (CTDMO) has the capacity to work with clients to design assays which fit product-specific requirements. 

In this webinar, you will learn about:

• Applicability of ddPCR to nucleic acid quantitation assays
• Comparability between ddPCR and qPCR
• Design of ddPCR tests and controls
• ddPCR assays offered by WuXi Advanced Therapies and development capability

Leveraging the Blow-Fill-Seal Process and Cold BFS Technology for Biologics

The advanced aseptic processing of Blow Fill Seal (BFS) technology for primary container liquid packaging has a long and proven history.  For decades, this technology has been gaining prevalence and wide support as a standard of care in the respiratory and ophthalmic markets for the packaging of nebulized liquid and unit and multi dose eye droppers. BFS is a highly automated process that forms a container, fills it with product, then seals it – all without human intervention and within the machine in a Class A environment.  This drastically reduces the risk of microbial and foreign particulate contaminants during the filling process, making BFS a superior form of advanced aseptic packaging.

BFS packaging is used extensively by organizations for a wide variety of products, including solutions, suspension, and emulsions. While sterile packaging is equally important for biologics and large molecule formulations, some organizations are hesitant to consider BFS because the process uses heat to melt and form plastic resin into a container, which could potentially impact the product’s integrity.

Woodstock Sterile Solutions’ patented Cold BFS technology and proven history of manufacturing a commercial biologic minimizes that concern by maintaining temperature balance throughout the BFS process. This webinar will cover Blow Fill Seal technology, explain why it is essential for aseptic packaging, and how Cold BFS technology has made BFS a viable solution for biologics and large molecule formulations.

Key Learning Objectives:

• An understanding of the BFS technology and manufacturing process
• Advantages of BFS over glass packaging
• The impact of temperature on product during the BFS process
• An understanding of cold BFS processing and its advantages

Sterility, Manufacturing & Regulatory Challenges in a Constantly Changing World of Biopharmaceuticals

The Biopharmaceutical sector has been changing very rapidly from monoclonal antibodies to Cell and Gene Therapy and RNA-based Therapeutics. The growing healthcare needs demand cost effective and rapid manufacturing technologies. The approval of biosimilars and continuous manufacturing has joined hands with manufacturers to meet these demands. This shift from fixed stainless steel to single use systems (SUS) has revolutionized the therapeutic market. The rapid market growth for SUS, composed primarily of plastic components that are sealed and sterilized using irradiation, is expected to continue. This webinar will focus on product development, including sterilization and lab testing strategies, to help ensure there is no contamination in the development and manufacturing of SUS to promote end-user safety.

Sustained Release Microspheres: Achieving Success from Post-Feasibility to GMP Manufacturing

The drug delivery industry typically focuses on new technologies and confirming proof of concept studies. However, one of the true challenges begins post-feasibility in scaling the desired formulation without impacting critical quality attributes, as well as transferring the process from a R&D laboratory to a GMP manufacturing facility to initiate clinical batch production. This talk will outline the typical steps Oakwood takes during post-feasibility, scale-up, technology transfer, and Phase I clinical batch production. We will discuss some of the challenges we have encountered with previous projects, and solutions to optimize success.

Microbiological Testing Considerations for Pharmaceutical Products

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

How To Ensure Safe, Smart, AND Sustainable Packaging

For pharmaceutical and healthcare companies, today’s complex secondary packaging requirements can be an overwhelming challenge. Finding the right structural design and building and maintaining a strong brand, combined with the pressures of meeting sustainability goals can prove tricky. Join us with Colbert Packaging as they present how to achieve packaging solutions that provide The Total Package.

• 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

New Horizons in Lipid Nano Particle Production

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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

Clinical to Commercial Manufacturing: Selecting the Right CDMO for Your Sterile Drug Product

Taking a drug product from clinical to commercial-scale production is a complex process with numerous variables to consider. Finding an appropriately-sized CDMO to help you go to market can be difficult, especially when manufacturing capacity shortages are common and many CMOs focus on more established or high-volume products. Companies who are developing sterile products, such as injectable or ophthalmic dosage forms, must also ensure manufacturing sites are prepared for the challenges of aseptic manufacturing.
 
To find the right partner, you must know what to look for in a CDMO. In this webinar from Lubrizol Life Science Health (LLS Health), we will describe how LLS Health’s CDMO Division is meeting the need for commercial aseptic manufacturing capacity through our recent site expansion and explore key considerations when selecting a CDMO for commercial supply, including:

• 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

Hunt for N-Nitrosamines in Medicinal Products

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

From Capital Builds to Staff Augmentation: Tips to Achieving Integrated CQV Strategies

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

Bioprocessing Technologies: Stainless Steel vs Single Use

Join us for a brief introduction of the current competing market between Stainless Steel and Single Use Systems, with a further in-depth analysis of the capabilities and benefits of stainless steel systems. We will also look into the lessons learned regarding the affect of the COVID pandemic on manufacturing with stainless steel and single use systems.

Speaker:

Justin Carbungco
Group Leader of Manufacturing Operations, Samsung Biologics

Lessons Learned: Choosing and Managing a CDMO

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

Digitalization and the Future of Formulating in Modern R&D Labs

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