Over the past decade CBSET has partnered with more than 400+ MedTech and BioTech companies, including start-ups and industry-leading corporations, enabling them to initiate clinical studies and gain subsequent US and OUS market approvals for their novel therapeutic, imaging and diagnostic technologies.
Biosimilar CMC Analytical Master Files & Development SolutionsCovance
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
This document summarizes the Gavin Herbert & USC Vision clinical scientist fellowship program between Allergan and USC School of Pharmacy established in 1977. The fellowship aims to train pharmacists to be experts in both clinical practice with patients and physicians as well as research in the laboratory. Fellows gain drug development and commercialization experience at Allergan while also participating in academic activities at USC such as precepting students, guest lecturing, and attending regulatory science courses. The program has a 100% success rate of fellows obtaining jobs in pharmaceutical industry roles such as regulatory affairs, clinical development, medical affairs, and more.
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
This document discusses analytical solutions for assessing the biosimilarity of a potential biosimilar to OPDIVO (nivolumab). It provides a pre-developed analytical master file containing preliminary critical quality attributes of OPDIVO, analytical methodologies to test these attributes, and preliminary reference data using OPDIVO. This master file can help support biosimilar development and provide a head start in assessing biosimilarity compared to de novo development. A comprehensive testing strategy is proposed to thoroughly characterize the biosimilar candidate and establish its biosimilarity to OPDIVO.
The candidate has over 10 years of experience in laboratory science roles of increasing responsibility. She currently works as a senior scientist developing and validating assays for pharmaceutical clients. Previously she evaluated, developed and validated FDA approved assays as a development scientist and gained experience operating various analytical instrumentation. The candidate holds a Bachelor's degree in Biology.
The Use Of Error and Uncertainty Methods in the Medical LaboratoryShrineCaete
This document discusses error and uncertainty methods for evaluating measurement data in medical laboratories. It summarizes that error methods are simpler and more intuitive than uncertainty methods but both are complementary. When evaluating laboratory results to support medical diagnoses, total uncertainty includes analytical, biological, and pre-analytical and post-analytical variations. The document also outlines the key concepts of bias, imprecision, total analytical error, measurement uncertainty and how they are calculated and combined. It acknowledges challenges that both error and uncertainty methods face in practical application and the need for future consensus on their use in performance specifications.
Over the past decade CBSET has partnered with more than 400+ MedTech and BioTech companies, including start-ups and industry-leading corporations, enabling them to initiate clinical studies and gain subsequent US and OUS market approvals for their novel therapeutic, imaging and diagnostic technologies.
Biosimilar CMC Analytical Master Files & Development SolutionsCovance
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
This document summarizes the Gavin Herbert & USC Vision clinical scientist fellowship program between Allergan and USC School of Pharmacy established in 1977. The fellowship aims to train pharmacists to be experts in both clinical practice with patients and physicians as well as research in the laboratory. Fellows gain drug development and commercialization experience at Allergan while also participating in academic activities at USC such as precepting students, guest lecturing, and attending regulatory science courses. The program has a 100% success rate of fellows obtaining jobs in pharmaceutical industry roles such as regulatory affairs, clinical development, medical affairs, and more.
The successful development of a biosimilar presents unique challenges compared to that of an innovator biologic. In particular, one must prove the biosimilar candidate's structural and functional differences do not have a meaningful impact on the clinical safety and efficacy profile already established for the innovator. Comprehensive and rigorous analytical testing to assess biosimilarity is thus the foundation upon which the successful development of a biosimilar begins.
This document discusses analytical solutions for assessing the biosimilarity of a potential biosimilar to OPDIVO (nivolumab). It provides a pre-developed analytical master file containing preliminary critical quality attributes of OPDIVO, analytical methodologies to test these attributes, and preliminary reference data using OPDIVO. This master file can help support biosimilar development and provide a head start in assessing biosimilarity compared to de novo development. A comprehensive testing strategy is proposed to thoroughly characterize the biosimilar candidate and establish its biosimilarity to OPDIVO.
The candidate has over 10 years of experience in laboratory science roles of increasing responsibility. She currently works as a senior scientist developing and validating assays for pharmaceutical clients. Previously she evaluated, developed and validated FDA approved assays as a development scientist and gained experience operating various analytical instrumentation. The candidate holds a Bachelor's degree in Biology.
The Use Of Error and Uncertainty Methods in the Medical LaboratoryShrineCaete
This document discusses error and uncertainty methods for evaluating measurement data in medical laboratories. It summarizes that error methods are simpler and more intuitive than uncertainty methods but both are complementary. When evaluating laboratory results to support medical diagnoses, total uncertainty includes analytical, biological, and pre-analytical and post-analytical variations. The document also outlines the key concepts of bias, imprecision, total analytical error, measurement uncertainty and how they are calculated and combined. It acknowledges challenges that both error and uncertainty methods face in practical application and the need for future consensus on their use in performance specifications.
The Future of Laboratory Medicine: Understanding the New CoercionsCayeVerunque
The document discusses how laboratory medicine is undergoing major changes due to advances in technology and economic pressures. Laboratories provide various diagnostic tests and equipment that have evolved rapidly. It is important for laboratories to understand outcomes and quality management to contribute to improved patient care. Laboratories also need to better promote their interface with clinical practices by providing interpretive comments, using reflex testing, and conducting clinical audits to ensure high quality patient care and support multidisciplinary activities.
The Michigan State University In Vivo Facility aims to enable life sciences research by providing high-quality animal testing services. It offers both standard and specialized pharmacology assays, drug discovery/development services, and medical device testing to support academia and industry. The facility has experienced staff with drug development expertise who can perform a range of in vivo tests in normal and disease models across multiple therapeutic areas like cardiovascular, infectious disease, and oncology. Custom evaluations and animal models are developed to meet unique customer needs.
Kristy Vogt has over 20 years of experience in laboratory science and quality assurance. She holds a Master's degree in Quality Assurance and Regulatory Science and has worked in roles managing laboratories and research evaluations. Her expertise includes food microbiology, infection control, and dental materials compliance.
Proclinical is a life science recruitment company that works with large pharmaceutical companies across multiple countries, providing professionals across the entire drug development life cycle. The document then describes the 5 stages of drug development, as well as the role of regulatory affairs.
The author's role at Proclinical involved reaching out to life science professionals via LinkedIn or phone to discuss job opportunities. They also participated in briefing calls with pharmaceutical clients to learn about current projects and roles. The role required organizing interviews, follow-ups, and delivering offers to candidates while meeting daily and weekly targets. Overall, the placement provided exposure to opportunities in the pharmaceutical industry and vital work skills.
Some considerations when undertaking research within the Critical Care Environment; presentation to students in the Graduate Diploma of Critical Care Nursing - University of Canberra
A Web based Tool for Medical Laboratories Performance MonitoringShola Adeyemi
The document proposes a web-based tool for monitoring and evaluating medical laboratory performance in Nigeria. It would allow the Medical Laboratory Science Council of Nigeria to assess laboratory results and quality measures in real time. The tool would provide an interface between laboratories and stakeholders to monitor performance. A statistical methodology using random effects modeling would capture quality measures. The paper outlines the tool's architecture, requirements, feasibility, and underlying statistical approach. It concludes the tool would strengthen regulatory oversight and improve laboratory evaluations.
This document provides an overview of analytical method validation for biopharmaceuticals. It discusses the different types of analytical methods used in the biopharmaceutical industry, including screening methods, release and stability methods, and characterization methods. It emphasizes that method validation is important but guidelines have focused on validation for commercial products, leaving a gap for earlier stages of development. The document then discusses best practices for qualifying characterization methods and release/stability methods to demonstrate suitability for intended use during development.
10th Annual Bioassays and Bioanalytical Method Development Conference Report ...Doranelly (Dolly) Koltchev
The 10th Annual Bioassays and Bioanalytical Method Development Conference brought together scientists from industry, academia, and regulatory agencies to discuss trends in cell-based assays and bioanalysis. Presentations evaluated new technologies and their impact on bioassay methods and workflows. Regulatory perspectives on draft guidance were provided. Discussions focused on strategies to develop sensitive and reproducible bioassays, challenges in validating assays for clinical samples, novel technologies to expedite drug development, and ensuring continuity of data through assay transfers. The conference provided a forum for collaborative discussions around critical issues in bioanalytical method development.
1) The document announces a training session on Good Manufacturing Practices (GMP) of the 21st century to be held on April 4th, 2021. It discusses how GMP standards have evolved over time to focus more on product development, process understanding and control strategies.
2) GMP via a quality management system is important for ensuring drug quality and preventing errors, as testing a small sample cannot guarantee the quality of an entire batch. Advances in technology are reshaping GMP requirements.
3) The training methodology will include tutorials, interactive discussions, and real-world case studies to describe regulatory expectations and keep learning objectives aligned. Participants will be assessed in real-time.
“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”Rajatmishra137
The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
Lior - Improving Medication Safety in RadiologyLior Molvin
This webinar explores medication safety issues in radiology settings. It will discuss cases where errors have occurred and risk reduction strategies. Nationally recognized experts will address topics like safe contrast use, proper labeling, expiration dating, and patient identification. Faculty will examine a new Imaging Bulk Package for contrast approved by the FDA and regulatory/Joint Commission requirements for contrast and medication use in radiology. The goal is for pharmacists and radiologic technologists to understand medication ordering, storage, preparation and use in radiology; differentiate new Imaging Bulk Packages from Pharmacy Bulk Packages; and identify system causes of radiology medication errors to prioritize prevention strategies.
The publication of the Standards of Practice for Clinical Pharmacists by the American College of Clinical Pharmacy (ACCP) establishes a standardized process of care for clinical pharmacists focused on comprehensive medication management. This addresses the lack of consistency in clinical pharmacy practice that has hindered research and collaboration. The Standards define the clinical pharmacist's role, responsibilities, and documentation of patient care. Consistent application of these Standards can help other health professionals better understand clinical pharmacists' contributions to patient care and outcomes.
This document provides information about an upcoming conference on oncology endpoints and quality of life assessments taking place in November 2015 in Philadelphia. Attendees will learn about (1) selecting clinical trial endpoints and interpreting quality of life measures to satisfy regulatory requirements, (2) understanding patient needs when designing trials and assessing oncology endpoints, and (3) developing patient-reported outcome tools to evaluate the benefits and risks of treatments. Featured speakers will provide insights and case studies on rapidly changing practices for endpoint selection and validation in oncology trials.
1. Process analytical technology (PAT) aims to shift pharmaceutical development and manufacturing from testing quality through sampling to building quality into products using continuous monitoring and control strategies.
2. PAT involves establishing quantitative relationships between raw materials, process parameters, and product quality attributes to decrease variability, contamination, and costs while improving quality.
3. The goals of PAT include encouraging innovation through a risk-based regulatory framework that facilitates new manufacturing technologies and ensures consistent application of regulations.
Alice K Gray has over 8 years of experience in microbiology, including 4 years in supervisory roles, in both clinical and manufacturing settings. She is currently a Lead Microbiologist at BioMerieux in Hazelwood, MO where she leads investigations into quality control issues and supports process improvements. Her qualifications also include a Bachelor's of Science in Biology and Medical Technology certification.
Erin Perez is a registered nurse with over 10 years of experience in nursing, quality improvement, and scientific research. She currently works as a float pool nurse at Washington Hospital, where she assists with various quality improvement projects. Previously, she has held roles conducting health education and vaccinations, implementing an MRSA testing protocol, and developing analytical methods in biochemistry research labs. Perez received her MSN in Clinical Nurse Leadership from the University of San Francisco and has relevant experience, skills and certifications in nursing, research, and quality improvement.
This document provides a summary of the qualifications and experience of Manoj Tyagi, Ph.D. He has over 15 years of experience in quality management, regulatory compliance, and laboratory accreditation. Currently he serves as the Chief Scientific Officer and Laboratory Director of Captiva Lab LLC, where he oversees CLIA and accreditation compliance. He has extensive expertise in clinical chemistry, toxicology, and workplace drug testing.
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
Pharmaceutical Quality - The Office ofAjaz Hussain
The keynote address at the Fall meeting of the CPPR Industrial Advisory Board and the Site Directors held yesterday (27 October 2014) at Purdue University. The talk provides a perspective on the recent organizational changes announced by FDA CDER - the Office of Pharmaceutical Quality.
Pbio Investor Presentation Global Online Growth Conference - Oct 2016RedChip Companies, Inc.
This investor presentation discusses Pressure BioSciences, Inc. (PBIO), a company that develops and sells instruments and consumables for biological sample preparation using pressure cycling technology (PCT). The presentation provides an overview of PBIO's business, leadership, financials, and growth opportunities. Key points include PBIO having over 275 PCT systems installed, generating $1.8 million in revenue in 2015, closing a $5 million investment to strengthen its balance sheet, and partnering with SCIEX, a leader in mass spectrometry, to co-market PCT sample preparation solutions. The presentation outlines PBIO's focus on the estimated multi-billion dollar markets for sample preparation and mass spectrometry and its goal to achieve
This presentation provides an overview of Pressure BioSciences, Inc. Key points include:
- PBI develops instruments and consumables for pressure cycling technology (PCT) sample preparation. PCT uses repeated high-pressure cycles to control molecular interactions.
- PBI's primary market is the biopharma industry, where PCT systems are used from biomarker discovery through validation and quality control. Over 270 PCT systems have been installed.
- A new next-generation PCT instrument, the Barocycler 2320EXTREME, was recently released.
- PBI is also developing ultra-shear technology to produce nanoemulsions for applications in food, pharmaceuticals, and other
The Future of Laboratory Medicine: Understanding the New CoercionsCayeVerunque
The document discusses how laboratory medicine is undergoing major changes due to advances in technology and economic pressures. Laboratories provide various diagnostic tests and equipment that have evolved rapidly. It is important for laboratories to understand outcomes and quality management to contribute to improved patient care. Laboratories also need to better promote their interface with clinical practices by providing interpretive comments, using reflex testing, and conducting clinical audits to ensure high quality patient care and support multidisciplinary activities.
The Michigan State University In Vivo Facility aims to enable life sciences research by providing high-quality animal testing services. It offers both standard and specialized pharmacology assays, drug discovery/development services, and medical device testing to support academia and industry. The facility has experienced staff with drug development expertise who can perform a range of in vivo tests in normal and disease models across multiple therapeutic areas like cardiovascular, infectious disease, and oncology. Custom evaluations and animal models are developed to meet unique customer needs.
Kristy Vogt has over 20 years of experience in laboratory science and quality assurance. She holds a Master's degree in Quality Assurance and Regulatory Science and has worked in roles managing laboratories and research evaluations. Her expertise includes food microbiology, infection control, and dental materials compliance.
Proclinical is a life science recruitment company that works with large pharmaceutical companies across multiple countries, providing professionals across the entire drug development life cycle. The document then describes the 5 stages of drug development, as well as the role of regulatory affairs.
The author's role at Proclinical involved reaching out to life science professionals via LinkedIn or phone to discuss job opportunities. They also participated in briefing calls with pharmaceutical clients to learn about current projects and roles. The role required organizing interviews, follow-ups, and delivering offers to candidates while meeting daily and weekly targets. Overall, the placement provided exposure to opportunities in the pharmaceutical industry and vital work skills.
Some considerations when undertaking research within the Critical Care Environment; presentation to students in the Graduate Diploma of Critical Care Nursing - University of Canberra
A Web based Tool for Medical Laboratories Performance MonitoringShola Adeyemi
The document proposes a web-based tool for monitoring and evaluating medical laboratory performance in Nigeria. It would allow the Medical Laboratory Science Council of Nigeria to assess laboratory results and quality measures in real time. The tool would provide an interface between laboratories and stakeholders to monitor performance. A statistical methodology using random effects modeling would capture quality measures. The paper outlines the tool's architecture, requirements, feasibility, and underlying statistical approach. It concludes the tool would strengthen regulatory oversight and improve laboratory evaluations.
This document provides an overview of analytical method validation for biopharmaceuticals. It discusses the different types of analytical methods used in the biopharmaceutical industry, including screening methods, release and stability methods, and characterization methods. It emphasizes that method validation is important but guidelines have focused on validation for commercial products, leaving a gap for earlier stages of development. The document then discusses best practices for qualifying characterization methods and release/stability methods to demonstrate suitability for intended use during development.
10th Annual Bioassays and Bioanalytical Method Development Conference Report ...Doranelly (Dolly) Koltchev
The 10th Annual Bioassays and Bioanalytical Method Development Conference brought together scientists from industry, academia, and regulatory agencies to discuss trends in cell-based assays and bioanalysis. Presentations evaluated new technologies and their impact on bioassay methods and workflows. Regulatory perspectives on draft guidance were provided. Discussions focused on strategies to develop sensitive and reproducible bioassays, challenges in validating assays for clinical samples, novel technologies to expedite drug development, and ensuring continuity of data through assay transfers. The conference provided a forum for collaborative discussions around critical issues in bioanalytical method development.
1) The document announces a training session on Good Manufacturing Practices (GMP) of the 21st century to be held on April 4th, 2021. It discusses how GMP standards have evolved over time to focus more on product development, process understanding and control strategies.
2) GMP via a quality management system is important for ensuring drug quality and preventing errors, as testing a small sample cannot guarantee the quality of an entire batch. Advances in technology are reshaping GMP requirements.
3) The training methodology will include tutorials, interactive discussions, and real-world case studies to describe regulatory expectations and keep learning objectives aligned. Participants will be assessed in real-time.
“LET US KNOW ABOUT QUALITY BY DESIGN IN PHARMACEUTICAL INDUSTRY”Rajatmishra137
The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .
Lior - Improving Medication Safety in RadiologyLior Molvin
This webinar explores medication safety issues in radiology settings. It will discuss cases where errors have occurred and risk reduction strategies. Nationally recognized experts will address topics like safe contrast use, proper labeling, expiration dating, and patient identification. Faculty will examine a new Imaging Bulk Package for contrast approved by the FDA and regulatory/Joint Commission requirements for contrast and medication use in radiology. The goal is for pharmacists and radiologic technologists to understand medication ordering, storage, preparation and use in radiology; differentiate new Imaging Bulk Packages from Pharmacy Bulk Packages; and identify system causes of radiology medication errors to prioritize prevention strategies.
The publication of the Standards of Practice for Clinical Pharmacists by the American College of Clinical Pharmacy (ACCP) establishes a standardized process of care for clinical pharmacists focused on comprehensive medication management. This addresses the lack of consistency in clinical pharmacy practice that has hindered research and collaboration. The Standards define the clinical pharmacist's role, responsibilities, and documentation of patient care. Consistent application of these Standards can help other health professionals better understand clinical pharmacists' contributions to patient care and outcomes.
This document provides information about an upcoming conference on oncology endpoints and quality of life assessments taking place in November 2015 in Philadelphia. Attendees will learn about (1) selecting clinical trial endpoints and interpreting quality of life measures to satisfy regulatory requirements, (2) understanding patient needs when designing trials and assessing oncology endpoints, and (3) developing patient-reported outcome tools to evaluate the benefits and risks of treatments. Featured speakers will provide insights and case studies on rapidly changing practices for endpoint selection and validation in oncology trials.
1. Process analytical technology (PAT) aims to shift pharmaceutical development and manufacturing from testing quality through sampling to building quality into products using continuous monitoring and control strategies.
2. PAT involves establishing quantitative relationships between raw materials, process parameters, and product quality attributes to decrease variability, contamination, and costs while improving quality.
3. The goals of PAT include encouraging innovation through a risk-based regulatory framework that facilitates new manufacturing technologies and ensures consistent application of regulations.
Alice K Gray has over 8 years of experience in microbiology, including 4 years in supervisory roles, in both clinical and manufacturing settings. She is currently a Lead Microbiologist at BioMerieux in Hazelwood, MO where she leads investigations into quality control issues and supports process improvements. Her qualifications also include a Bachelor's of Science in Biology and Medical Technology certification.
Erin Perez is a registered nurse with over 10 years of experience in nursing, quality improvement, and scientific research. She currently works as a float pool nurse at Washington Hospital, where she assists with various quality improvement projects. Previously, she has held roles conducting health education and vaccinations, implementing an MRSA testing protocol, and developing analytical methods in biochemistry research labs. Perez received her MSN in Clinical Nurse Leadership from the University of San Francisco and has relevant experience, skills and certifications in nursing, research, and quality improvement.
This document provides a summary of the qualifications and experience of Manoj Tyagi, Ph.D. He has over 15 years of experience in quality management, regulatory compliance, and laboratory accreditation. Currently he serves as the Chief Scientific Officer and Laboratory Director of Captiva Lab LLC, where he oversees CLIA and accreditation compliance. He has extensive expertise in clinical chemistry, toxicology, and workplace drug testing.
This presentation by Pressure BioSciences discusses their Pressure Cycling Technology platform for biological sample preparation. Some key points:
- PCT uses ultra-high pressure to break up cell walls and extract biomolecules, achieving better results than mechanical methods.
- The market for biological sample preparation is multi-billion dollars. PCT addresses the need for improved sample prep methods.
- Over 275 PCT systems have been installed at over 150 customer sites. There are over 100 publications highlighting PCT's advantages.
- Recent accomplishments include a co-marketing agreement with SCIEX, a leader in analytical technologies, and sales of their new Barocycler 2320EXTREME system.
Pharmaceutical Quality - The Office ofAjaz Hussain
The keynote address at the Fall meeting of the CPPR Industrial Advisory Board and the Site Directors held yesterday (27 October 2014) at Purdue University. The talk provides a perspective on the recent organizational changes announced by FDA CDER - the Office of Pharmaceutical Quality.
Pbio Investor Presentation Global Online Growth Conference - Oct 2016RedChip Companies, Inc.
This investor presentation discusses Pressure BioSciences, Inc. (PBIO), a company that develops and sells instruments and consumables for biological sample preparation using pressure cycling technology (PCT). The presentation provides an overview of PBIO's business, leadership, financials, and growth opportunities. Key points include PBIO having over 275 PCT systems installed, generating $1.8 million in revenue in 2015, closing a $5 million investment to strengthen its balance sheet, and partnering with SCIEX, a leader in mass spectrometry, to co-market PCT sample preparation solutions. The presentation outlines PBIO's focus on the estimated multi-billion dollar markets for sample preparation and mass spectrometry and its goal to achieve
This presentation provides an overview of Pressure BioSciences, Inc. Key points include:
- PBI develops instruments and consumables for pressure cycling technology (PCT) sample preparation. PCT uses repeated high-pressure cycles to control molecular interactions.
- PBI's primary market is the biopharma industry, where PCT systems are used from biomarker discovery through validation and quality control. Over 270 PCT systems have been installed.
- A new next-generation PCT instrument, the Barocycler 2320EXTREME, was recently released.
- PBI is also developing ultra-shear technology to produce nanoemulsions for applications in food, pharmaceuticals, and other
The document discusses the concept of Pharmaceutical Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science and quality risk management. QbD aims to design quality products and manufacturing processes that consistently deliver intended performance, following ICH guidelines Q8 on pharmaceutical development, Q9 on quality risk management, and Q10 on pharmaceutical quality systems. Implementing QbD provides benefits like eliminating batch failures, minimizing deviations, and ensuring consistent product quality.
Pressure BioSciences is presenting their pressure cycling technology instruments and consumables. Their flagship product is the Barocycler 2320EXTREME instrument, which uses high pressure cycling to prepare biological samples for analysis. They have over 270 PCT systems installed worldwide and publications highlighting the advantages of PCT in biopharma sample preparation from discovery to clinical use. The company is poised for growth with their exclusive marketing agreement with SCIEX, expanded sales team, and focus on the multi-billion dollar biopharma market.
Join us in learning the newest trends and technical advances in the use of Polymeric Materials in Medical Applications; speakers are from premier institutions such as the world-class Ronald Reagan Medical Center at UCLA, ABBOTT Vascular, JOHNSON & JOHNSON-Cordis, BOSTON SCIENTIFIC, MEDTRONIC, REVA Medical, MiMEDX, BECKTON DICKINSON, ROCHE Diagnostics and more.
For Registration / Sponsorship / Details, please CLICK the link below:
http://www.MediPlastConference.com
Richard Boeh has over 25 years of experience in quality management and cGMP compliance for pharmaceutical and biopharmaceutical companies. He has extensive experience designing and implementing quality management systems, leading quality departments, and providing training. Some of his accomplishments include creating quality management systems for 3 start-up organizations that successfully passed FDA inspections, and providing FDA cGMP warning letter remediation for 2 organizations. Currently he works as an independent consultant providing compliance and quality management services to the pharmaceutical industry.
This investor presentation summarizes Pressure BioSciences' business and technology. PBI develops and sells instruments and consumables for sample preparation using its patented Pressure Cycling Technology platform. Key points include that PBI has over 275 PCT systems installed, has accomplished revenue growth and debt reduction in recent years, and signed a marketing agreement with SCIEX to co-promote its PCT-SWATH technology for mass spectrometry applications. The presentation outlines PBI's technology applications, market opportunities, customer base, and near-term growth drivers including the SCIEX partnership and new product releases.
Review Article: PROCESS ANALYTICAL TECHNOLOGY- Innovative pharmaceutical deve...Vignan University
Process Analytical Technology in pharmaceutical production checks the quality of the raw material attributes
both physically and chemically, that too off-line, in-line or on-line. Process analytical technologies have been
applied to manufacturing processes for decades. PAT is a system for design, analysis, and control of
manufacturing processes, 1
based on continuous monitoring/rapid measurements of critical quality and
performance attributes of raw material, intermediates and products. PAT involves measurement science by
using conventional process sensors such as pressure, temperature and probes. The PAT initiative was initially
intended for traditional pharmaceutical manufacturers, but the FDA.s, PAT guidance now clearly states that it
applies to all manufacturers of human and veterinary drug products. PAT involves shift from testing the quality
to building quality into products by testing at several intermediate steps. It specifically requires that
quantifiable, causal, and predictive relationships be established among the raw materials. There by decreasing
the chances of contamination and cross contamination. It also saves a huge amount of time and money required
for sampling and analysis of the products. Overall PAT paves a way for producing a quality product thus
satisfying the customer needs and creating a good brand image for the organization. PAT that will encourage
the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and
quality assurance as well as novel analyzer technologies.
This document provides an overview of Good Manufacturing Practices (GMP) guidelines from various regulatory authorities like WHO, US FDA, ICH, and MHRA. It discusses the objectives of GMPs, including ensuring product quality and compliance. The key GMP guidelines from WHO, US FDA, and ICH are summarized, covering topics like pharmaceutical quality systems, sanitation procedures, and guidelines for quality control. Validation is also discussed as important for quality assurance and reducing compliance issues.
John J. DiClerico Jr. is an experienced scientific leader with over 10 years of experience in molecular cell biology and biochemistry, focusing on oncology and Alzheimer's disease. He holds a Master's degree from Columbia University and has worked in quality control roles for several pharmaceutical companies, developing assays and ensuring compliance. He is currently a QC Associate Lead at Lifecell Corporation, where he oversees quality control testing and laboratory operations.
Annac, st. john,miller,ostertaag combined pp ccp13 ccp13bio-link
The document discusses InvivoSciences' contributions to regenerative medicine through phenotypic screening and analysis of engineered tissue mechanics. IVS provides miniaturized engineered tissues to mimic organs/tissues for rapid compound screening and assays to analyze drug-induced changes. They focus on tissues relevant to diseases impairing organ mechanics like muscular dystrophy, fibrosis, and COPD. Contact information is provided for Ayla Annac, CEO of IVS, and Tetsuro Wakatsuki, CSO of IVS.
IGPA Building a Culture of Quality Ajaz Hussain_5 Sept 2015_Rferences minAjaz Hussain
Improving Confidence in Quality of Medicines . We make two products – medicine and evidence (documents) but many forget this and do not pay attention to documentation.
Level of attention to documentation is a “canary in a coal mine”
Breaches are irrational –”System 1 thinking” and cognitive biases.
Culture of Quality is familiar to all of us – a framework proposed
Quality Metrics – great idea – very much needed; but we are not yet ready for an FDA Guidance.
We must first address our collective blind spots; be confident that process validation truly ensures complexity is sufficiently reduced and that outcomes are predictable.
The presentation discusses the current state of quality management in the pharmaceutical industry and a proposed future "desired state" based on a risk-based, science-driven approach. It highlights guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) including ICH Q6A on specifications and ICH Q8 on pharmaceutical development. The desired state focuses on process understanding, continuous monitoring and improvement rather than just documentation and testing to ensure consistent product quality.
This document provides updated tables for antimicrobial susceptibility testing standards from the Clinical and Laboratory Standards Institute (CLSI). It summarizes the key changes from the previous supplement. The tables should replace earlier versions and are only valid if the CLSI testing methodologies are followed. It aims to help laboratories and clinicians select appropriate drugs and interpret test results.
1. An experienced Quality system professional knowledgeable in all facets of
current Good Manufacturing Practices(CGMP) for biopharmaceutical drugs
,and Medical Devices, including assay development; preclinical product
development and assessment; cGMP manufacturing of clinical materials,
APIs, and final products; regulatory submissions; and quality system design
and management. A proven leader for resolving CGMP problems and
troubleshooting complex system problems related to product development,
manufacturing, regulatory affairs, quality assurance, and quality control of
biopharmaceuticals, Pharmaceuticals and Medical devices.
EDUCATION
University of New Mexico, Albuquerque, NM, BS., (ChE)
Warren Wilson College, Swannanoa, NC, BA., (Biochemistry)
Univ, Ithaca, New York B.S., (Biochemistry)
HONORS
Award of Merit, Knights of Columbus, 2010
National Institutes of Health Special Research Fellowship, National
Institute of General Medical Sciences, 1971 to 1973.
Best CAPA Instructor “ Peer Review, CGMP University Inc,2008
Consultant of the year, “Peer Review, CGMP University Inc, 2011.
2. PROFESSIONAL ACTIVITIES
Lecturer and author in the areas of Quality Control and Assurance of
Biologics, Pharmaceuticals and Devices.
Co-founder and CEO of CGMP University Inc.
Instructor in Principles of Process Validation, Canadian
Pharmaceutical Institute, Ontario, Canada.
Instructor in Principles of Process validation, Center for Applied
Training, London, UK.
PROFESSIONAL SOCIETIES
Regulatory Affairs Professionals Society
IPA
American Society for Quality
PUBLICATIONS
1. “How to write Standard Operating Procedures and work Instructions.” David
N.Muchemu, Creatspace, October 2010.
2. “How to perform process Validation”, David N.Muchemu, creatspace, May 2010
3. “Principles of process validation.” David N.Muchemu, Creatspace, January
2011.
4. „Design Control for Medical Device,” David N.Muchemu, Creatspace, May 2011
5. “Change control for FDA regulated Industries,‟ “David
N.Muchemu,Authorhouse,2007
6. “How to design a CAPA system” David N.Muchemu, Authorhouse, 2008.
7. “How to design a Quality system” David N.Muchemu,Authorhouse,2008
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