Webinars

Novel Therapeutic Manufacturing Trends

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


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

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


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Sightline: A New Generation of Respiratory Hoods

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


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

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


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

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


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Early CMC Strategies to Support Late-Stage Success

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


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

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)


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Ensuring Stability Excellence for Global Consumer and OTC Products

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


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

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


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Biosynthesis of Chiral Compounds at Hiray Pharma Solutions

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 MileyVP of Business Development - North America
Hiray Pharma Solutions


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New Approaches in Bispecific Antibody Development

New Approaches in Bispecific Antibody Development

01.25.23

An emerging class of next-generation antibodies, bispecific antibodies (bsAb) can create a wide range of applications to meet the current unmet needs of patients. In this webinar, we will introduce S-DUAL bispecific antibody platform that enables high purity, thermostability, and manufacturability by eliminating mispairing risks, while maintaining high-quality structure for your novel finding.

Speaker:

Jina Kim
Senior Scientist of Bio R&D Center - Samsung Biologics


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Application of Risk-Based Approach in a ATMPs Multi-Product Facility

Application of Risk-Based Approach in a ATMPs Multi-Product Facility

12.08.22

ATMPs are complex products and risks may differ according to the type of product and level of complexity of the manufacturing process. The risk-based approach facilitates the manufacturer to design the organizational and technical measures that are put in place to comply with GMPs and thus to ensure quality according to the specific risks of the product and the manufacturing process. While the risk-based approach brings flexibility, it also implies that the manufacturer is responsible to put in place the control measures that are necessary to address the specific risks of the product and of the manufacturing process, and to demonstrate the aseptic capability of such processes.

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Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1

Meeting the Container Closure Integrity Requirements in the Revised EU Annex 1

11.10.22

A Science-Based Holistic Approach
 

The revision of EU GMP Annex 1, Manufacture of Sterile Medicinal Products, was finalized on 25 August 2022 and includes new requirements for ensuring the container closure integrity (CCI) of sterile pharmaceutical products. This webinar will present how sterile product manufacturers can prepare themselves for the new regulations, a science-based holistic approach to ensure good CCI and include a description of CCIT methods that can be used for frozen products needing cold chain storage and transport.

 

  1. Learn in detail how the new requirements of the revised EU Annex 1 may impact your strategy for ensuring the container closure integrity (CCI) of sterile pharmaceutical products.
  2. Gain understanding of the advantages and disadvantages of container closure integrity testing methods and why a science-based holistic approach to ensure good CCI is important.
  3. Learn how cold chain storage and transport can impact the CCI of sterile pharmaceutical products.

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Release & Stability Testing Requirements for Parenteral Drug Products

Release & Stability Testing Requirements for Parenteral Drug Products

11.03.22

Parenteral products are sterile drugs, solutions, emulsions and suspensions. Parenteral products are unique from any other type of pharmaceutical dosage form for the following reasons: All products must be sterile and free from pyrogenic (endotoxin) contamination.

Release and stability testing are a vital part of new drug development and is conducted throughout a product’s life cycle. These studies confirm that the quality, safety, and effectiveness of drug products are preserved all through the shelf life as an essential requirement. This presentation will provide a brief overview of the parenteral drug products release testing as well as the ICH guidelines for stability testing.


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Expansion and Preparedness for the Post-Pandemic

Expansion and Preparedness for the Post-Pandemic

10.25.22

Topics that will be addressed:
 

  • Market trends - supply & demand in biopharmaceutical manufacturing
  • Beyond COVID - diversified modalities, challenges and supply chain
  • What you should look for in a CDMO

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