-
Jan 21, 2025 | 
cellandgene.com | Tyler Menichiello |Grant Merrill
In this segment of the executive roundtable discussion, our panelists express optimism about the promising future of allogeneic cell therapies and discuss other innovations in the field. Essential Strategies For IVT OptimizationOptimizing in vitro transcription (IVT) for mRNA is crucial to improving the stability of these molecules and enabling their large-scale production.
-
Sep 24, 2024 | 
cellandgene.com | Tyler Menichiello |Grant Merrill |Todd Andrews
Setting the Standard in Cell and Gene Therapy, TogetherSartorius shares your mission to develop life-changing cell and gene therapies. Accelerate commercialization with end-to-end solutions that deliver reproducibility, scalability, and the quality needed to simplify regulatory approvals. From discovery, to process development, to clinical and commercial manufacturing, our portfolio of proven solutions helps you achieve faster time-to-market while saving costs.
-
Aug 1, 2024 | 
cellandgene.com | Erin Harris |Raul P. Lima |inSeption Group |Grant Merrill
Digital Data: Your Roadmap To Supply Chain EfficiencyJoin the eData movement! Learn how life science manufacturers are embracing digital transformation as they see it as the pathway to a patient-focused future of high-quality therapeutics. Learn more. Raj Bandaru, Associate Director in Regulatory Affairs and U.S. Regulatory Affairs Lead at Accenture provides rich context on parts of the recent FDA Draft Guidance, Rare Diseases: Considerations For The Development Of Drugs And Biological Products.
-
May 14, 2024 | 
pharmaceuticalonline.com | Irwin Hirsh |Q-Specialists AB |Grant Merrill |Carol Houts
Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs. An Introduction To Laminar Airflow Technology In Aseptic ProcessingExplore the vital role that laminar airflow technology plays in meeting sterile integrity standards and minimizing contamination risks in pharmaceutical cleanrooms.
-
Feb 28, 2024 | 
sme.org | Grant Merrill
The biopharma industry is shifting toward advanced-therapy, medicinal products (ATMPs), such as cell and gene therapies, to treat chronic and rare disease indications. These therapies work by targeting the root cause of the disease, providing a potentially curative solution, and moving away from the need for long-term repeat dosage.
-
Jan 9, 2024 | 
cellandgene.com | Antony Hitchcock |AGH Bioconsulting |Grant Merrill
Webinar: Slow The Burn Part 2: A Deeper Dive On How To Mitigate Financial Risk Before Selecting An Outsourcing VendorJoin us January 23 as we dive deeper into the common red flags to look for, the critical questions to ask, and best practices for safeguarding your trial's budget. Click here to learn more. AAV-vectored drugs can potentially be used to treat population-level diseases. But biopharmaceutical companies will have to get better at producing them. Here are some areas to focus on.
-
Aug 21, 2023 | 
pharmaceuticalonline.com | Grant Merrill
Article
| August 21, 2023
By Grant Merrill
The demand for aseptic processing capacity in the pharmaceutical industry is on the rise, primarily due to the growing need for injectable drugs. Here, we examine the potential of laminar airflow technology to enable the industry and its partners to fulfill this demand while adhering to stringent global sterile integrity standards.
-
Aug 21, 2023 | 
cellandgene.com | Grant Merrill
Article
| August 21, 2023
By Grant Merrill
The demand for aseptic processing capacity in the pharmaceutical industry is on the rise, primarily due to the growing need for injectable drugs. Here, we examine the potential of laminar airflow technology to enable the industry and its partners to fulfill this demand while adhering to stringent global sterile integrity standards.
-
May 25, 2023 | 
pharmaceuticalonline.com | Victoria Meyer |Joe Hoff |Oliver Stauffer |Grant Merrill
A conversation with Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Quality Executive Partners In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, .
-
Apr 3, 2023 | 
themedicinemaker.com | Grant Merrill
Companies need to pay close attention to how they build out their advanced therapy medicinal products (ATMP) delivery supply chains. Autologous treatments require individual cell harvesting and a manufacturing cycle that begins and ends with the patient. Allogeneic therapies are also developed from human cells but are donor-derived and manipulated to treat groups of patients.
