Webinars

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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HPAPI Safety Solutions to Augment Containment SOPs

HPAPI Safety Solutions to Augment Containment SOPs

10.13.22

In this educational webinar, you will learn about various PAPR (Powered Air Purifying Respirators) respiratory solutions to augment and enhance current flexible containment systems. PAPRs offer a reliable, scientifically valid means to safely handle HPAPI and offer protection in many other pharmaceutical applications, such as aseptic processing and LAR. Protection, comfort, and value are critical components to any PAPR system and SOP. Join us to learn about positive pressure systems and the how they provide superior comfort and operator-usability when compared to masks; plus, you’ll take away the following:
  • An understanding of protection factors required for your application
  • An overview of various cartridge options available contingent on hazard
  • The benefit of no required fit testing
  • Availability of 10~6 sterility assurance head tops for cleanrooms
  • New technologies for available for lighter duty filling and handling

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Platform Based Scalable Suspension Process for LVV Production

Platform Based Scalable Suspension Process for LVV Production

09.29.22

Lentiviruses have been widely used for cell therapy based applications. This presentation will showcase IDT Biologika’s platform based approach for Lentiviral Vector production.

Additionally, analytical methods for determining both the physical and functional titer will be described, which are used to assess the efficiency of Lentiviral Vector production.

The strategies described here will enable a scalable and robust process that focuses on suspension transient transfection of serum free HEK cells.


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8 Trends in Contract Manufacturing

8 Trends in Contract Manufacturing

09.15.22

The trend toward outsourcing pharmaceutical development and manufacturing has accelerated during COVID as pharma companies — both in the US and abroad — seek to streamline their own facilities, focus on core competencies and avoid product delays inherent in overseas manufacturing. Partnering with a CDMO allows them to access more specialized knowledge, state-of-the-art equipment and qualified staff, as well as reduce their total cost of ownership, all while maintaining speed to market.

As both a CDMO and a manager of CMOs, Avéma Pharma Solutions sees a number of trends emerging that CDMOs must embrace to be successful including:


  • More strategic, integrated relationships
  • Narrower product focus
  • Emphasis on development
  • End-to-End support and manufacturing flexibility
  • Re-evaluating supply chain management
  • Manufactured in the USA
  • Continuous reinvestment
  • Consultive relationships

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Sterile Nanoemulsion Product Development: Challenges and Future Prospects

Sterile Nanoemulsion Product Development: Challenges and Future Prospects

09.07.22

Nanoemulsion has the potential to overcome several disadvantages in drug formulation. Nanoemulsions are nano-sized emulsion which can improve the bioavailability of the drug molecules via various route of administration. The development of nanoemulsion formulation is a challenging and lengthy process. Selecting component such as oil phase, surfactant, an optimum oil to surfactant ratio, and ideal process parameters are critical for developing a stable nanoemulsion. Development becomes more complicated when a drug molecule is sensitive to a variety of factors. This webinar will discuss, with a case study, a nanoemulsion development process using a microfluidizer, and factors to consider while developing a sterile ophthalmic nanoemulsion formulation for a light, oxidation, and heat-sensitive molecule.

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Building Trust Between Clinical Trial Stakeholders through a DCT Framework

Building Trust Between Clinical Trial Stakeholders through a DCT Framework

08.23.22

In 2022, a record 1,300 trials will launch with a decentralized or virtual component according to Clinical Trials Arena. This growth is greatly impacting our industry, changing the ways in which sites interact with patients and study teams.

Clinical research sites face many challenges to retain the number of patients needed to successfully complete and validate the integrity of a study. Sites continually strive to improve patient recruitment and engagement practices for clinical trials to provide sponsors with the critical data they need to bring new medications to market safely.

As roles continue to evolve, it’s paramount to ensure that the sites are engaged and supported in a way that makes their everyday work easier and more effective.

In this webinar, a panel of industry experts will showcase how to design a framework of decentralized offerings that provide greater ease of use, effectiveness, and flexibility for sites for every type of research setting; decentralized/hybrid, virtual, or in-person. In addition, they will discuss how DCT solutions and site partners are creating an impact to improve DEI while optimizing clinical research for patients.

Attendees will learn about:

  • The crucial role of sites in modern decentralized clinical research
  • How the role of sites will evolve as decentralized research continues to grow
  • How to design a DCT framework built around the needs of sites while also addressing patient engagement and diversity
  • The importance of actively engaging sites in new and novel ways to help facilitate this shift and ensure success

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GMP Analytical Testing in Gene Therapy Products

GMP Analytical Testing in Gene Therapy Products

08.09.22

Gene therapy holds the promise to transform medicine and creates options for the patients who are living with incurable diseases. The industry has been booming in the last 20 years. Before a gene therapy product can be used in humans, the product must be tested for safety and effectiveness.

For in vivo genome modification, the most used gene delivery method is by Adeno-associated virus (AAV) vectors. For AAV-based gene therapy products, a full scale of testing methods have been established to ensure the identity (CE-SDS, LC-MS, Q-PCR/D-PCR), potency (A260/A280, HPLC, TCID50 and Infectivity assay), purity (Host cell DNA/Protein, residual plasmid DNA, Residual BSA and Benzonase by ELISAs, residual cesium, RCA, AUC for Empty : Full ratio), and safety (BioBurden, Endotoxin, Sterility, Mycoplasma, etc.).

For in vitro genome modification, Lenti virual vectors are used to genetically modify the patient’s own T cells to express a chimeric antigen receptor (CAR) designed to recognize and bind to a target antigen on tumor cells to eliminate the tumor cells. For Lenti viral gene therapy products, genomic titer and p24 ELISA are widely used for the calculation of viral titer. In addition to the mentioned assays, RCL, VSVg, and SV40 tests are often used as a safety test for Lenti viral products.

This webinar will focus on the introduction of three critical test methods: AUC, Infectivity and RCL assays. Newly released FDA draft guidance for Industry on human gene therapy products will also be discussed.


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Contamination Control For Pharmaceutical Products

Contamination Control For Pharmaceutical Products

07.27.22

Real-World Moist Heat Validation Pitfalls And Proper Verification Of Sterility

Moist heat sterilization is a commonly used and widely accepted process in pharmaceutical processes. As such it is critical that it be carried out correctly. In this webinar we will address real-world observations relating to moist heat sterilization processes, discuss the science behind the observations and present solutions to result in a successful validation outcome.

 

As a contamination control program is meant to result in microbiologically acceptable product, usually with a sterile claim, it is also critical to be capable of demonstrating sterility. Although demonstration or verification of sterility is commonly accomplished by performance of a test for sterility via USP<71>, that test only represents one slide in the complete movie of contamination control, thus a fuller perspective of verification of sterility must be considered and will be addressed.

 

The format of the webinar will be an introduction to these two topics followed by a panel discussion to address your specific questions or challenges and updates in the industry.


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Sensitivity Enhancement in Point of Care Diagnostics Using Gold Nanoshell Probes

Sensitivity Enhancement in Point of Care Diagnostics Using Gold Nanoshell Probes

07.21.22

Nanoparticles are emerging as powerful tools for research, therapeutic, and diagnostic applications and their utility as lateral flow test probes has gained prominence in recent years. As the need for more sensitive tests increases, new types of nanoparticles are being investigated and incorporated into lateral flow assays.


This webinar will highlight:
 

  • The advantages and disadvantages of some common covalent reporter probe types.
  • The unique properties of nanoComposix Gold Nanoshells and how they relate to lateral flow assays.
  • Examples of assays where sensitivity enhancement was achieved with gold nanoshells.
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Benefits of MycoSEQ™ for Faster Mycoplasma Detection

Benefits of MycoSEQ™ for Faster Mycoplasma Detection

07.07.22

Mycoplasma contamination can have devastating effects on the manufacture of cell and gene therapies, requiring the destruction of production batches and halting of manufacturing processes, and ultimately, in delayed provision of treatments to patients.

Rapid and sensitive tests are necessary for lot release to ensure the absence of mycoplasma contamination. The compendial culture-based method, although highly sensitive, takes 28 days to complete and requires specialized training and reagents as well as extensive lab space.

In contrast, MycoSEQ™ is a PCR-based assay which offers sensitivity comparable to the culture-based method but with much faster delivery, able to provide results within 24 hours. The rapid testing offered by MycoSEQ™ makes it ideal for in-process testing across the complex biomanufacturing workflow as well as for lot release. It is now widely used and accepted by regulatory authorities including U.S. FDA and EMA, and is offered by WuXi Advanced Therapies as part of our testing portfolio.

In this webinar you will learn:

  • Regulatory requirements for mycoplasma testing within the cell and gene therapy pipeline
  • How WuXi Advanced Therapies applies their experience to support customers with mycoplasma testing
  • The benefits of the MycoSEQ™ assay compared with culture-based methods
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Droplet Digital PCR (ddPCR) for Sensitive Testing in Advanced Therapy Manufacturing

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

03.03.22

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

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

02.01.22

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

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