Webinars

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

Rapid Analysis of Residual Solvents and Volatile Impurities for High-Throughput CDMO Workflows

09.12.23

Contract drug manufacturing organizations (CDMOs) are essential for the testing of pharmaceutical products for their safety and efficacy. Many analytical tests are run in accordance with federal regulations and guidelines, including the analysis of residual solvents, extractables, leachables, degradation products and impurities in excipients. These tests require a plethora of instrumentation and trained users to operate these individual tests. In this webinar, we introduce our new compliant real-time mass spectrometer solution, Syft Tracer Pharm11. A single instrument is capable of running up to 220 samples per day, and multiple methods and analyses can be performed in sequence. The direct headspace-SIFT-MS instrument is chromatography-free, and therefore the need for multiple columns and instrument downtime between methods does not exist.

We will highlight several common CDMO tests that have been performed and validated using headspace SIFT-MS, including residual solvents, ethylene oxide, nitrosamines and other extractables & leachables.

Speakers:

Christopher Williams
Director of Development Services, Alcami Corporation

Leslie Silva, PhD
Applications Scientist, Syft Technologies

Container Closure Integrity Testing (CCIT) for Pharmaceutical Sterile Barrier Packaging

07.27.23

CCIT testing is used to evaluate pharmaceutical packaging such as vials, syringes, auto injectors and IV bags for sterile barrier integrity breaches.  This presentation will review all the common CCIT methods found in USP <1207> to compare the testing options. The presentation then explores CCIT method validation approaches and pitfalls to enhance understanding of how methods can be applied to different sample types.

Deterministic vs. probabilistic methods (why choose one over the other)?
How do the different methods work?
How do you set up a validation for a CCIT method?
What are some pitfalls to avoid during the validation?

Speaker:

Jennifer Gygi
Expert Technical Consultant
Nelson Labs

Early CMC Strategies to Support Late-Stage Success

07.19.23

Focus on a good strategy for early drug product CMC development is critical for commercial success. A well-structured, forward-looking, and phase-appropriate CMC development strategy, including risk assessments and mitigation plans at various stages, is crucial for avoiding late-stage roadblocks, dead-ends, and rework. Good decisions in early CMC development can provide flexibility for the clinic, faster and lower cost development, and a more streamlined commercial manufacturing process that provides better results and lower unit conversion costs.

Learning Objectives:

Formulation mindset for clinical flexibility and process scalability
Analytical approaches to reduce re-validation and workload
The importance of early-stage CMC risk assessment

Speakers:

Dr. Neha Shah
Director, Product Development - Societal™ CDMO

Dr. Kiran Pedada
Associate Director, Analytical Development - Societal™ CDMO

Complex in Complex – New Hopes for Better Drug Delivery in Topical Dosage Formulation

06.22.23

The skin structure is very complex and consists of several layers of lipids. Therefore, targeting better drug delivery in the skin layers by semisolid dosage formulation is always a challenge. Designing a formulation that has a similar structure to skin and the same lipids type selection makes this delivery easier. Newer techniques, such as the use of liposomes, in the topical formulation help to carry the drug to the desired site and improve efficacy. Adopting various manufacturing techniques, such as multi-emulsion formulation, can be used for this approach.

The webinar will be focused on:

Basic concepts
Challenges in drug delivery
Introduction of liposomes to topical “Complex in Complex” formulation
Advantages of “Complex in Complex” formulation
Designing, manufacturing, and characterization

Speaker:

Chetan Chure
Senior Manager, Formulation Development
Contract Pharmaceuticals Limited (CPL)

Ensuring Stability Excellence for Global Consumer and OTC Products

03.07.23

Stability testing is an essential step in the product development process, and a mandatory requirement in the life cycle of a treatment. The International Council on Harmonisation - Quality (ICHQ1A) guidance exists to support companies in maintaining a rigorous approach to stability testing. This webinar will explore the detail of ICH Q1A and explain how to meet its requirements.

Speaker:

Ramesh Jagadeesan
Asst. Vice President, Analytical Development
Recipharm

CDMO Selection and Tech Transfer – An Insider’s Guide to Injectables Excellence

03.02.23

Choosing the right CDMO partner can make all the difference.

This highly informative and engaging webinar will feature two SMEs - one from the CDMO side and one from the client innovator side. Together they'll share best practices, success stories, and battle scars earned over 25 years of drug development, analytical testing, and cGMP manufacturing, and offer a look at what to expect in 2023 and beyond.

Benefit from their experience, absorb their insights, and adopt the partnering strategies that can help save you time, money and unnecessary headaches.

Speakers:

Ryan Downey
Director of Customer Operations - August Bioservices

Mary Senica
SVP, Quality and Compliance - Eirion Therapeutics

Biosynthesis of Chiral Compounds at Hiray Pharma Solutions

02.16.23

Enzymatic biocatalysts can be expertly designed to catalyze the synthesis of chiral compounds in highly efficient, specific, and selective manners as compared to classical chemical synthesis. This webinar will offer a representative look at some of the research and CDMO projects executed by Hiray Pharma Solutions’ Laboratory of Biocatalysis and Enzyme Engineering. A fundamental background of the science, challenges, and advantages of these projects will be provided. In addition, this webinar will feature a brief tour of Hiray’s brand new small molecule manufacturing facility on the company’s 35-acre campus in Jingmen, China. A brief conclusion will follow along with responses to some key questions which have recently been asked of Hiray.

Speakers:

Mika Kwan - Project Manager - R&D
Hiray Pharma Solutions

Kavuluru Venkata Hemakumar - Technical Support Manager - Technology Department
Hiray Pharma Solutions

Tim Miley - VP of Business Development - North America
Hiray Pharma Solutions