Addressing the Workforce Shortage: A Collaborative Approach to GMP Programs for Building a Skilled Pharma and Biotech Talent Pipeline: Poster Presented at PDA Week 2025 [0.03%]
解决劳动力短缺问题：合作方法制定GMP计划，培养技能娴熟的制药和生物技术人才管道：PDA周2025大会墙报展示
Christian Spiak
Christian Spiak
The shortage of skilled workers in the pharmaceutical and biotech sectors has become a significant barrier to industry growth and the success of new companies in local areas. Without a reliable talent pool trained in essential industry stan...
Comparison of Small Virus Clearance and Flowrates Between Meissner's SepraPor® Hollow Fiber Ultrafiltration 50 kDa and 500 kDa Filter Membranes Using ΦX174 Bacteriophage: Poster Presented at PDA Week 2025 [0.03%]
Meissner's Seppro® 50kda和500kda超滤膜与ΦX174噬菌体的清除率及流速比较：2025年PDA周会议展示的壁报论文
Zachary Bendiks,Mao Kohara,Leesa McBurnie
Zachary Bendiks
Viral clearance by virus-retentive filters is a crucial step in many biomanufacturing process streams, including production of monoclonal antibodies and cell culture media. Studies with model viruses or bacteriophage are needed to determine...
Transforming Risk into Opportunity: Unlocking the Power of a Quality Risk Management Playbook: Poster Presented at PDA Week 2025 [0.03%]
化风险为机遇：质量风险管理手册的力量：PDA周2025海报展示
Jerry Tischler
Jerry Tischler
Navigating the complexities of compliance in the biopharmaceutical landscape-particularly for cell and gene therapies-requires innovative and effective solutions. In response to these challenges, Syner-G | Sequoia have developed a Quality R...
Beyond Quality Culture: Fostering a Holistic Work Environment: Poster Presented at PDA Week 2025 [0.03%]
超越质量文化：培育整体性工作环境：在PDA周2025上展示的海报
Kumbirai Dhliwayo
Kumbirai Dhliwayo
Quality culture is an integral part of a workplace and is one of the foundational traits that lead teams to prioritize compliance and the safety of patients. However, quality culture is merely one of the byproducts of corporate culture. Loo...
Strategy to Evaluate Performance of Lyophilization Stoppers: Poster Presented at PDA Week 2025 [0.03%]
评估冷冻干燥胶塞性能的战略：在PDA周2025会议上展示的海报
Sonia Adamidis
Sonia Adamidis
Lyophilization, the process of dehydrating a material at low temperature and reduced pressure, is used to extend the shelf life of biologic drug products. Because the object is extended shelf life, long-term performance testing of any lyoph...
Ensuring Data Integrity in Digitalized Manufacturing: Risk-Based Strategies for Achieving GxP Compliance: Poster Presented at PDA Week 2025 [0.03%]
数字化制造中的数据完整性保障：实现GXP合规性的基于风险的策略：在2025年PDA周大会上的海报展示内容
Peniel Ortega
Peniel Ortega
The digital transformation of pharmaceutical manufacturing brings about several opportunities and challenges in ensuring data integrity, one of the foundational elements of GxP compliance. As automated systems, advanced analytics, and inter...
Microbial Control for Nonsterile Drug Manufacturing Product Contact Surfaces: Poster Presented at PDA Week 2025 [0.03%]
非无菌药物生产产品接触表面的微生物控制：2025年PDA周大会发表的海报
Antonio Ortiz
Antonio Ortiz
There is an understanding of how cleaning processes for pharmaceutical equipment used in aseptic operations are implemented not only for controlling drug product cross-contamination, but also for the initial reduction in bioburden prior to ...
Image-Based Culture Plate Readers and Microbiological Testing of Mixtures - is It Necessary? Poster Presented at PDA Week 2025 [0.03%]
基于图像的培养板读取器和混合物微生物检测的必要性——2025年PDA周大会壁报展示
Chris Ramsey,Steven Giglio
Chris Ramsey
As the use of imaging devices and artificial intelligence (AI) gain traction in culture plate reading, the question of performance on detection of mixtures of organisms often arises. This is typically borne through traditional thoughts of v...
Maximizing Gene Therapy Doses for Patients: Poster Presented at PDA Week 2025 [0.03%]
用于患者的最大化基因治疗剂量：在PDA周2025上展示的海报
Peter Gegusch
Peter Gegusch
Proposal DescriptionGene therapies hold tremendous potential, yet manual operations, product loss, and high costs impede patient access to vital treatments. The fill/finish processes are pivotal in optimizing drug product availability. Prec...
A Comparative Study of Polysorbate Adsorption to Membrane Filters for Fill & Finish Applications, Considering a Potentially Upcoming Restriction of the Use of PFAS Based Membranes, Such as PVDF: Poster Presented at PDA Week 2025 [0.03%]
聚山梨酯对膜过滤器在填充和完成应用中吸附的比较研究，考虑到未来可能限制使用PFAS基膜（如PVDF）的潜在规定：PDA周2025会议展示海报
Mariam Salamatian
Mariam Salamatian
A comparative study of Polysorbate adsorption to membrane filters for Fill & Finish applications, considering a potentially upcoming restriction of the use of PFAS based membranes, such as PVDF. ...