Webinars

Application of QbD Approach for Tech Transfer and Process Characterization of Biologics

11.19.24

The biopharmaceutical industry exists to develop novel therapeutics that address unmet medical needs. The evolving research and development landscape for these complex therapeutics has made streamlining their scaling and commercialization an increasingly crucial consideration. For many biotechs, this means finding a sustainable contract manufacturing and development organization (CDMO) capable of executing seamless tech transfer and guiding a therapeutic asset to market acceptance and beyond. The increasing demand for expedited timelines for the CMC (chemistry, manufacturing and control) program and drug approval process should be supported by facility capacity, flexibility as well as technical capability for seamless tech transfer in CDMO. Through effective technology transfer mechanisms, stakeholders can accelerate the translation of scientific breakthroughs into lifesaving treatments.

Quality by Design (QbD) is a strategic approach that intends to ensure the high quality of drugs by employing statistical and risk-management methodology in the design, development and manufacturing of drugs. Over the years, QbD's focus has been on the process design, understanding, as well as process control, as discussed in the ICH guidance. The core principle of QbD is to identify and comprehend the relationships between the product's CQAs (Critical Quality Attribute) and the CPPs (Critical Process Parameter) that influence them. This process understanding is obtained through a combination of holistic risk assessment, design of experiments (DoE), and statistical analysis though the study called Process Characterization (PC). Understanding of criticality and ranges of process parameters along with defining process design space is essential for establishing a robust Process Control Strategy (PCS) during tech transfer.

This presentation covers the application of the QbD principle for effective and efficient tech transfer and process characterization to complete scale-up/scale-down of bioprocesses while ensuring the safety and quality of biologics for patients.

Speaker:

Youngsun Kim
Senior Director of the Multi Modality MSAT Team, Samsung Biologics

Analytical Challenges for CMC Development of Cell and Gene Therapy Products

11.13.24

Innovative solutions and best practices for accelerating development timelines while maintaining product quality.
Addressing the challenges of ensuring safety, potency, and efficacy in advanced therapies.

Rapid Detection Methods in Cell & Gene Therapies: Sterility & Mycoplasma Testing

10.15.24

The demand for Rapid Detection methods in the Cell and Gene Therapy space has evolved from an amenity to a necessity. This presentation will explore two common tests required for Cell and Gene Therapy Products: Sterility and Mycoplasma testing. Beyond that, this presentation will explore the requirements and capabilities of two Rapid Methods specifically: Rapid Sterility by Respiration Detection and Rapid Mycoplasma testing by quantitative PCR.

In this webinar, viewers will gain insight into Rapid Sterility testing methods, with a focus on Rapid Detection Via Respiration. Additionally, Rapid Mycoplasma testing will be discussed, with details on qPCR as the method of choice. In both tests, requirements, strengths, and challenges to each method will be explored.

Who should attend:

Quality Assurance/Control Specialists
Regulatory Affairs Professionals
Researchers and Scientists
Microbiology Lab Analysts

Speaker:

Melisa Byrd
Microbiology Supervisor, Element Materials Technology

Redefining Drug Development with the inGenius™ Platform

09.19.24

Over the past two decades, the biopharma community has faced significant challenges in advancing exciting and potentially life-saving new targets into the clinic. Throughout this time, Ingenza has partnered with numerous customers and collaborators, developing a suite of innovative platform technologies that are critical to the success of any drug development program. Inspired by groundbreaking advances in genomics, artificial intelligence, and genome editing over the last decade, Ingenza has refined its approach to accelerate and de-risk the path to IND.

In this webinar, Dr. Rita Cruz, Section Head of Strain Development at Ingenza, will introduce Ingenza’s inGenius™ platform, which plays a pivotal role in speeding up a candidate’s journey to the clinic. The inGenius™ platform includes efficient and proven biomanufacturing hosts and processes that boast a 20-year track record of successful delivery, from novel antibiotic candidates to next-generation vaccines and biologics. By integrating Ingenza’s proprietary gene design algorithm (codABLE), a comprehensive library of genetic parts, advanced genome editing tools, FACS-assisted optimization of protein expression, and customized fermentation protocols, the inGenius™ platform rapidly demonstrates bioprocess IND readiness to meet future manufacturing productivity, quality and cost requirements.

This webinar will provide invaluable insights into the past, present, and future of biotech innovations, highlighting how Ingenza’s passion for using biology to transform our world continues to drive the incredible journey of engineering biology. Join us to explore how these revolutionary technologies can accelerate your drug discovery and development efforts, ultimately bringing transformative therapies to patients faster and more efficiently.

Speaker:

Dr. Rita Cruz, Ph.D.
Section Head, Strain Engineering, Ingenza

How QMS Impacts Quality Maturity

07.18.24

Join us for an interactive session with Susan Schniepp exploring various strategies behind quality maturity. You’ll learn about regulation changes and how each can impact your team’s success. A real time audience discussion will close the session and challenge your thinking about audit scenarios.

Speaker:

Sue Schniepp
Distinguished Fellow - Regulatory Compliance Associates® Co-Chair of Board of Directors, Parenteral Drug Association® (PDA)

PDUFA to Patients in 7 Days with Integrated Packaging Solutions

06.20.24

Join industry experts for an engaging webinar focused on streamlining new drug launches with integrated packaging solutions. Explore the crucial role packaging plays in the success of product launches and learn how optimization can lead to significant benefits.

In this session, we'll cover:

The benefits of streamlining packaging processes: Discover how efficient packaging solutions can reduce costs, improve speed to market, and reduce unnecessary risks by having the right partner.
The impact of packaging on new product launches: Gain insights into the pivotal role packaging plays in package design, brand recognition, and market compliance.
Overcoming challenges in new launch implementation: Learn strategies mitigate disruption by centralizing your supply chain strategy with an integrated enterprise solution from “PDUFA to patient.”

Don't miss this opportunity to gain valuable insights and stay ahead in the fast-paced world of pharmaceutical innovation. Reserve your spot now!

Speaker:

Tim Brown
Director, Operations, Cardinal Health Packaging Solutions

Prepared for the Next Pandemic - Utilizing New Production Capacities for Streamlined Vaccine Mfg

05.28.24

This informative webinar will delve into the critical aspects of pandemic preparedness, focusing on vaccine development and production. A blueprint of IDT Biologika’s newest state of the art production facility will be presented. Completed in 2022, the facility serves as one of the backbones for IDT’s vaccine manufacturing operations. Understanding the facility’s design and capabilities is crucial for process development. Attendees will learn about the methodology IDT used to establish a production process potentially capable of producing enough vaccines to ensure a rapid distribution to the population in the event of another pandemic. The successful transfer of this process from development scale to a production scale of 2000 liters will also be explained, and attendees will learn more about IDT’s current capacities for large-scale GMP compliant manufacturing of vaccines and biologics.

We look forward to sharing these exciting insights with you!

Key Learnings:

Facility Design: Get an inside view into IDT Biologika’s modern GMP compliant production facility and learn more about their current capacities and capabilities for large-scale biologics manufacturing.
Development Approach: Learn more about IDT’s pandemic preparedness program and how it sets up a generic process design for adenovirus vaccine mass production.
Smooth Transfer to Production: Attain an internal perspective on the challenges that come with large-scale transfer and how IDT overcame these during tech-transfer into production, as well, as how to incorporate these established learnings in future processes.

Speakers:

Daniel Minör
Head of Manufacturing, Senior Manager Production, IDT Biologika

Dakota Chenoweth
Team Lead, DSP Technologies Process Development, IDT Biologika

Daniel Hynek
Scientist, Upstream Process Development, IDT Biologika

Headspace Gas Ingress Methods - The Golden Tool for Container Closure Integrity Testing

05.15.24

It has become generally accepted that headspace gas ingress methods represent the most robust and flexible approaches for performing container closure integrity (CCI) testing throughout the product life cycle. As one of the deterministic techniques in the USP <1207> chapter on package integrity testing, headspace methods are based on non-destructive analytical measurements and are recommended for use in container closure integrity testing (CCIT) throughout the product life cycle to generate science-based CCI data that, coupled with a risk-based approach, enables informed decisions about a CCIT strategy in commercial manufacturing.

Headspace methods are the only ones to have been validated to detect gross leaks, sub-micron defects down to helium leak sensitivity, and leaks that are temporary. Methods that are developed for lab-based CCIT can be scaled for automated in-line testing in the manufacturing environment. Headspace methods are now regularly being implemented as the “golden tool” for CCIT of all types of sterile pharmaceutical product. The use of headspace methods for recent mRNA therapies as part of a holistic science-based approach to container closure integrity assurance has further demonstrated headspace as the most flexible and reliable deterministic method for CCIT.

This webinar will cover how headspace methods are developed and validated for a variety of product-container configurations including pre-filled syringes. Case studies will be presented that demonstrate the utility of headspace methods for meeting recent specific EU GMP Annex 1 requirements such as transport validation for product needing ultracold storage temperatures.

Speaker:

Derek Duncan, PhD
Director, LIGHTHOUSE Instruments

Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

05.01.24

The growing complexity associated with today’s clinical trials is driving sponsors to deploy non-traditional clinical supply strategies to address their changing needs. Whether they need to develop a more patient-centric strategy to support decentralized trials, meet the demands associated with accelerated approval pathways, or navigate highly complex supply chains for critical therapies, new approaches are needed. This session will explore several alternative clinical supply models, use cases and identify key considerations when adopting one of these models.

Speakers:

Aryama Mokoonlall Irmscher
Program Manager, Demand Led Supply, Catalent

Nicole Gray
Director, Decentralized Trial Solutions, Catalent

Trisha Demko
Director, Case Management Services, Catalent

Novel Therapeutic Manufacturing Trends

04.04.24

In this webinar, we will cover the key steps and considerations involved in bringing novel nanoparticle-based therapeutics from early R&D to commercial stages. Tailored to scientists, management, and business leaders in the pharmaceutical industry and academia, our discussion will navigate the journey from research to commercialization. Drawing from our nanomaterial-specific niche in the CDMO space and 20 years of experience, we will discuss considerations unique to nanomaterials during technology transfer, scale-up, and establishing quality controls. Gain insights from real-world case studies highlighting successful nanoparticle-based therapeutics projects from start to finish.

The interactive Q&A session will provide an opportunity to ask any questions about the scale-up and manufacture of nanomaterials and decision points throughout this process. Join us to discuss key considerations for each step from R&D through manufacturing.

Speaker:

Diana Dehaini, PhD
Project Manager & Technical Sales Scientist, nanoComposix | Fortis Life Sciences

Making the Complex, Simple: A Roadmap for Your OSD Journey

10.18.23

The pathway from early clinical phases to commercial is not straightforward, particularly for complex OSD products. As the project gets closer to the market - and with patients waiting for life-changing medicines - the need for a clear path to market becomes even more important.

From tech transfer complexities and issues arising in scaling to meeting unique packaging needs, there are many hurdles that must be carefully traversed to achieve a successful launch on time and without delay.

With a detailed map of the journey ahead, complex OSD manufacturers can anticipate and prepare for potential roadblocks, using an arsenal of tools to simplify their journey to market. By developing robust processes, utilizing operational excellence protocols and innovative solutions, controlling critical quality attributes (CQA) by process analytical technologies (PAT) and applying real time data sharing, including Real Time Release Testing (RTRT), the pathway to patients can be simplified and streamlined.

In this webinar, global Pfizer OSD scientists and manufacturing experts will share their unique insights on:

The difficulties complex OSD manufacturers can expect as their product progresses.
The importance of having the capabilities to support the unique needs of complex OSDs as the project scales.
The need for experience and expertise to proactively identify and prepare for the risks ahead.
Strategies that can be applied to minimize risk and simplify the journey as the project scales.

Speakers:

Ard Lura, PhD
Process Manager in Product and Process Development, Freiburg Germany site, Pfizer

Bruno Sciamanna
CDMO Business Development Manager, Ascoli Italy site, Pfizer

Kentaro Yoshimoto
Pfizer CentreOne lead, Nagoya, Japan site, Pfizer CentreOne

Ulrich Kaselow (Moderator)
Sr. Business Development Manager CDMO, Pfizer CentreOne

Sightline: A New Generation of Respiratory Hoods

10.05.23

Sightline is a new respiratory hood for the life sciences industry. This first-of-its-kind hood, with 320° of uninterrupted viewing, designed with the wearer in mind, is compatible with Bullard’s legendary EVA and EVAHL PAPRs.

Speakers:

Greg Steller
Life Science National Account Manager, Bullard

Paul Ostrowski
Regional Sales Manager, Bullard