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Articles by Robert Ossig
05.22.25 -- Combination Products: U.S. Vs. EU Requirements And A Harmonized Strategy To Prepare CTD Module 3
Webinar: Pharmaceutical Labeling: How To Optimize Labeling In A Pharmaceutical Environment Accurate and readable pharmaceutical labeling ensures patient safety, effective medication use, and regulatory compliance. In this webinar, you’ll learn how factors like speed, printing methods, and inspection criteria influence the choice of labeling machinery.
04.08.25 -- Training Specifically For Tech Transfer Skills Does Exist
Webinar: Keeping Hope Alive: Transforming Rare Disease Drug Development for a Faster Cure Join us on April 15th to explore how the rapid development of COVID vaccines sets a precedent for curative therapies for rare diseases. Learn how CDMOs expedite workflows, streamline manufacturing, and ensure reliable, scalable processes. Discover how supporting analytics and robust strategies accelerate the development, commercialization, and timely delivery of life-changing gene therapies.
03.24.25 -- AI Performance Management In Biologic And Drug Development
Challenging the Norm: Smaller Partners, Bigger Impact In our outsourcing industry, it is never an easy decision to select a partner when trying to run complex sequential trials. The need to gain regulatory approval for the treatments you have dedicated yourself to providing, coupled with the need to find a capable, reliable, and fair Contract Research Organization is quite daunting. Discover how a smaller full-service partner may be better suited to see your study through.
02.13.25 -- Regulatory-CMC: A Core Practice For Successful CDMO Partnerships
Webinar: The Analytical Journey of a Biologic Drug: From Discovery Through Commercialization Join this live webinar to learn about the journey of a biologic drug from pre-clinical to commercial release. SGS’s experts will share their extensive knowledge of testing required and ways to overcome challenges encountered throughout the various stages of the drug development process. Click here to learn more.
11.12.24 -- Emerging Partnership Trends In Oligo-Based Medicines
Tackling The Toughest Small Molecule Challenges Accelerating drug development is of utmost importance for bringing new drugs to patients faster, but the increased complexity in API development and manufacturing poses many challenges. Discover how to accelerate your small molecule API program with a strategic CDMO partner with the experience, expertise, and flexibility required to solve the toughest small molecule challenges. Learn more here.
10.21.24 -- Comparing In-House Vs. Outsourced Manufacturing Strategies For CGTs
On-Demand Webinar - The Road to Approval: Viral Clearance Strategies for Non-Enveloped Viral Vectors Did you know that the ICH Q5A(R2) guideline is now including the expectation for viral clearance studies for non-enveloped viral vectors? Watch this webinar to get the keys to design a successful study for your AAV products. Each approach has its advantages and drawbacks, making the decision-making process crucial for your organization.
09.19.24 -- Overcoming Setbacks On The Path To Commercialization
PAT: Build Quality into Biopharmaceutical Processes with Real-Time Monitoring and Control Automated aseptic sampling is a process analytical technology (PAT) tool that offers significant benefits for bioprocesses, including reduced contamination risk, higher measurement frequency, and improved efficiency compared to standard manual sampling. As a result, it enables improved process understanding and tighter process control. Learn more here.
The Handover Stage Of Technology Transfer: Ensuring A Seamless Transition For Commercial Production
Article | September 10, 2024 By Robert Ossig The Handover stage of transitioning from technology transfer (TT) to commercial production is a vital phase for biopharmaceutical companies. This stage involves transferring operations from the TT Team to the Receiving Unit (RU), requiring careful coordination across multiple functions.
Unlocking The Future: Exploring Cutting-Edge Cell And Gene Therapies
Article | August 12, 2024 By Robert Ossig, Process & Manufacturing Technology Explore the transformative potential of cutting-edge cell and gene therapies, focusing on CAR-T cell therapy, CRISPR-Cas9 gene editing, and other advanced approaches. CAR-T therapy involves engineering patient T cells to target and destroy cancer cells, exemplified by Kymriah for leukemia and lymphoma.
Unlocking The Future: Exploring Cutting-Edge Cell And Gene Therapies
Article | August 12, 2024 By Robert Ossig, Process & Manufacturing Technology Explore the transformative potential of cutting-edge cell and gene therapies, focusing on CAR-T cell therapy, CRISPR-Cas9 gene editing, and other advanced approaches. CAR-T therapy involves engineering patient T cells to target and destroy cancer cells, exemplified by Kymriah for leukemia and lymphoma.
The Execution Stage Of Technology Transfer
By Robert Ossig During a life sciences technology transfer (TT) project, the Execution Stage is the heartbeat of the overall effort, where the meticulous planning of the Readiness stage comes to fruition. This critical phase involves executing Process Performance Qualification (PPQ) and ensuring operational readiness and compliance at the Receiving Unit (RU).
The Execution Stage Of Technology Transfer
By Robert Ossig For companies completing a pharmaceutical technology transfer (TT) project, the Execution Stage is the exciting accumulation of all their efforts. It is the crucial stage where all their plans are implemented, including the execution of Process Performance Qualification (PPQ) and the assurance of operational readiness and compliance at the Receiving Unit (RU).
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