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Pharmatech Associates, a USP company
Registrace 30. 09. 2014
Pharmatech Associates, a global consultancy for the life science industry, advises U.S. and global drug sponsors and manufacturers of quality medicines in many major markets. A wholly owned subsidiary of U.S. Pharmacopeia (USP) with expertise in small molecule, cell & gene therapy, biologics -monoclonal antibodies- and advanced manufacturing technologies, Pharmatech Associates’ services include product and process development, quality management, quality assurance, and product management. Pharmatech Associates helps clients navigate the regulatory landscape of the FDA and international health authorities and provides guidance for U.S. market entry. Pharmatech Associates serves clients ranging from start-ups to large multi-national corporations.
Richard Steiner DCAT 2023 Improving Sustainability for Pharma Companies
Process intensification can be realized.
Financial benefits exist as well as the potential for meeting sustainability targets.
Financial benefits exist as well as the potential for meeting sustainability targets.
zhlédnutí: 32
Video
Richard Steiner DCAT 2023 Adapting to Shifts in Development Methods Under PCM Adoption
zhlédnutí 61Před 21 dnem
What could be the role of CDMOs when PCM picks up? We already see more and more Innovator products coming out of their installed CM platforms and dedicated CM product pipelines. Thus, the CDMO network plays an essential role in bridging the capacity between the drug owner and the patient for the safest, fastest, and most affordable market supply. Furthermore, in the case that Innovators don’t h...
Richard Steiner DCAT 2023 Different Needs for Different Manufacturers
zhlédnutí 177Před 21 dnem
Are there different NEEDS for the Innovators, Generic, or OTC manufacturing companies? Yes, of course. The 1st priority of most Innovators, whether small, medium, or large cap, is to get their new and innovative drug products to market as fast as possible. The focus for Generic is operational excellence and lower manufacturing costs. On the other hand, OTC companies are looking to increase prod...
Richard Steiner DCAT 2023 PCM to Prepare for the Next Wave of Pharma Innovation
zhlédnutí 64Před 21 dnem
What is your message to those CDMOs who have not yet invested in PCM? As a CMO/CDMO, you are better in the field of the first movers rather than the follower of the lead users. PCM is not something someone can implement during the night shift. It can take you a few years, depending on the scale of implementation and how much the customer of the CDMO is willing to invest in or support those effo...
Richard Steiner DCAT 2023 Platforms to Support CDMOs
zhlédnutí 105Před 21 dnem
Why is PCM such an important topic for the pharmaceutical manufacturing world? PCM can improve patient safety, affordability, and supply chain resilience. At the same time, it makes drug producers more successful. In a single investment, drug producers financially benefit while achieving new sustainability targets. PCM is the key to business success, establishing a competitive advantage, and su...
Richard Steiner DCAT 2023 Misconceptions about CM
zhlédnutí 103Před 28 dny
There are many misconceptions, myths, and old beliefs about continuous processing of pharmaceuticals in the public arena. What is most important to understand about Pharmaceutical Continuous Manufacturing PCM? As a CMO/CDMO, you are better in the field of the first movers rather than the follower of the lead users. PCM is not something someone can implement during the night shift. It can take y...
PCM Measuring Content Uniformity with PAT and RTR in oral solid dose applications
zhlédnutí 26Před měsícem
In Pharmaceutical Continuous Manufacturing (PCM), technical solutions ensuring critical quality attributes for content uniformity (CU) and unit dose exist for on-line, in-line, and at-line measurements. What is the best way to integrate PAT-based devices, to select sensor technologies; what best-practice solutions exist to avoid complexity in Overall Equipment Effectiveness (OEE)? This webinar ...
mABs Biosimilars from Lab to Clinical
zhlédnutí 45Před měsícem
Biosimilar monoclonal antibodies (mAbs) are essentially generic versions of their innovator counterparts. Antibodies with the same amino acid sequence are produced from different progenitor clones and manufacturing processes. Biosimilar mAbs may have a variety of differences owing to post-translational modifications, and this may affect quality. Regulatory authorities, including the FDA and EMA...
Mastering Quality Building a Strong Foundation for Your Pharma Startup
zhlédnutí 38Před 4 měsíci
Quality, with its checks and balances, is the foundation and a key to success for your pharma startup. A proactive, vigilant culture of quality is patient-focused and science-based, allowing you to identify and respond to issues while they are still small. It affects access and availability of medicines to support the commercialization of your product pipeline. Assuring quality becomes a compet...
PCM Business Cases Lets Get Specific
zhlédnutí 45Před 4 měsíci
For drug innovators, CDMOs, Over the Counter (OTC), or generics manufacturers, knowing how and when to adopt pharmaceutical continuous manufacturing (PCM) can speed time to market for your products, increase yield, reduce losses, and help your business thrive. This webinar presents the specific business case for each market segment when integrating advanced manufacturing technologies, including...
Modern Approaches to mRNA Manufacturing
zhlédnutí 67Před 8 měsíci
mRNA market in 2021 grew exponentially due to the success of COVID-19 vaccines by BioNTech, Johnson and Johnson and Moderna. As this technology shows promise, manufacturers are looking for modern approaches to scale production to meet overwhelming demand. This webinar will focus on current manufacturing processes for producing mRNA for vaccines.
PCM and Regulatory It’s All About the Data
zhlédnutí 44Před 8 měsíci
This webinar will guide you through the expectations of regulators when filing a Pharmaceutical Continuous Manufacturing (PCM) process for an Oral Solid Dose (OSD) drug product. Starting from the difference between a batch and a continuous process we cover the impact of evidence that needs to be generated so that the quality of the released product is assured, and how this will evolve throughou...
Modern Quality Techniques Patient centric Processes, Integrated QMS, Regulatory Intelligence
zhlédnutí 31Před 9 měsíci
For an organization to move to and thrive in a culture of quality involves having consistent, reliable, robust business processes and data that promote continual improvement and deliver on quality objectives. This webinar considers some of the most important aspect of quality management, including techniques to achieve a modern maturity model (QMM). We discuss potential areas of improvement, su...
PCM and Quality Upgrade Your Resolution
zhlédnutí 39Před 9 měsíci
In process development of a Pharmaceutical Continuous Manufacturing (PCM) oral solid dose (OSD) drug product, the goal is to identify all sources of variation and their impact on the quality of the final product. Implementing measures to properly mitigate or compensate variation will assure all product that goes to the patient is within pre-established quality specifications. This set of measur...
PCM Equipment Design Bringing the Pieces Together
zhlédnutí 86Před rokem
PCM Equipment Design Bringing the Pieces Together
Cost Savings Related to Qualifying Cell and Gene Therapy Facilities
zhlédnutí 50Před rokem
Cost Savings Related to Qualifying Cell and Gene Therapy Facilities
Richard Steiner shares his perspective on Pharmatech Continuous Manufacturing.
zhlédnutí 53Před rokem
Richard Steiner shares his perspective on Pharmatech Continuous Manufacturing.
PCM: What is the Best Business Strategy for You?
zhlédnutí 84Před rokem
PCM: What is the Best Business Strategy for You?
What You Need to Know About the EU GMP Annex 1 Revision
zhlédnutí 7KPřed rokem
What You Need to Know About the EU GMP Annex 1 Revision
Quality Considerations for a Robust Data Integrity Program
zhlédnutí 239Před rokem
Quality Considerations for a Robust Data Integrity Program
Auditing Alone Does Not Ensure Compliance
zhlédnutí 9Před rokem
Auditing Alone Does Not Ensure Compliance
An Environment for Mature Quality Management
zhlédnutí 2Před rokem
An Environment for Mature Quality Management
Quality Considerations for Aseptic Processing
zhlédnutí 243Před rokem
Quality Considerations for Aseptic Processing
Applying Process Analytical Technology PAT to Support Real Time Release
zhlédnutí 553Před rokem
Applying Process Analytical Technology PAT to Support Real Time Release
Cell & Gene Therapy Innovations to Drive Down Costs & Increase Efficiency
zhlédnutí 136Před rokem
Cell & Gene Therapy Innovations to Drive Down Costs & Increase Efficiency
The Difference Between Compliance and Quality
zhlédnutí 455Před rokem
The Difference Between Compliance and Quality
Good subjective presentation with highest hands on experience SME explanation.
Nice subjective presentation
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