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Articles by PSC Biotech
PSC Biotech Corporation Announces New Partnership with De Lama to Deliver Advanced Sterilization Solutions
Founded in 1949 in Italy, De Lama S.p.A. is a globally recognized leader in sterilization technology with more than 77 years of experience serving pharmaceutical and medical industries. Founded in 1996, PSC Biotech Corporation now serves more than 1,000 clients worldwide through professional services consulting, life science equipment rentals and sales, cloud-based software solutions, and pharmaceuticals contract manufacturing.
PSC Biotech Corporation Announces New Partnership with Blue Ocean Robotics
Blue Ocean Robotics and PSC Biotech enter a distribution agreement for the UVD Robot Pharma The UVD Robot Pharma eliminates up to 99.99999% (7-log) of microorganisms using 254 nm UV-C light PSC Biotech partners with Blue Ocean Robotics to distribute the UVD Robot Pharma delivering autonomous UV C disinfection for GMP cleanroom environments.
01.06.23 -- Cleanroom Gowning Programs Compliant With EU GMP Annex 1
By Crystal M. Booth, PSC Biotech Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.
01.02.23 -- Pfizer's Gene Therapies In 3 Minutes
Article | By Kristin Heller, Andrew Moreo, and Jonathan Rush, Andelyn Biosciences A CDMO with in-house plasmid manufacturing capabilities can help companies accelerate timelines and ensure material availability, ultimately saving time and money throughout their product's life cycle.
01.02.23 -- A Methodology To Support Particle Investigations In Biopharma Products
Is Your API Ready For Scale-Up? What To Demand From Your CDMO A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.
01.02.23 -- Pfizer's Gene Therapy Background In 3 Minutes
Outsourced Pharma Live Pfizer’s Firelli Alonso succinctly sums up the Big Pharma’s growth in the cell therapy space. In October 2022, Outsourced Pharma Live's What’s Driving The Cell & Gene Therapy Outsourcing Capacity Cycle? panelists discussed the identified macro and micro trends impacting deal-making at CDMOs. Exclusive data from BioPlan Associates was also presented.
12.22.22 -- FDA Accepts Biogen BLA For Biosimilar Actemra
By Crystal M. Booth, PSC Biotech This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
12.20.22 -- Cleanroom Gowning Compliant With EU GMP Annex 1
By Crystal M. Booth, PSC Biotech This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
12.14.22 -- Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
By Crystal M. Booth, PSC Biotech This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
12.13.22 -- CGT In 2023 With Cartesian, Poseida, REGENXBIO, And Spark
By Crystal M. Booth, PSC Biotech This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
Guest Column | December 1, 2022 By Crystal M. Booth, PSC Biotech Humans are the primary source of contamination in cleanrooms. Cleanrooms are designed to aid in the protection of the items being manufactured from environmental contaminants as much as possible. To protect the items being manufactured from human contamination, special gowning requirements are necessary. This is part 1 of a two-part series.
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
Guest Column | December 1, 2022 By Crystal M. Booth, PSC Biotech Humans are the primary source of contamination in cleanrooms. Cleanrooms are designed to aid in the protection of the items being manufactured from environmental contaminants as much as possible. To protect the items being manufactured from human contamination, special gowning requirements are necessary. This is part 1 of a two-part series.
Cleanroom Gowning Programs Compliant With EU GMP Annex 1
Get more pharma outsourcing insight with our FREE newsletter sign me up Development Contract Manufacturing Packaging Logistics Market Research Guest Column | December 15, 2022 By Crystal M. Booth, PSC Biotech Humans are the primary source of contamination in cleanrooms. Cleanrooms are designed to aid in the protection of the items being manufactured from environmental contaminants as much as possible.
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
Guest Column | December 1, 2022 By Crystal M. Booth, PSC Biotech Humans are the primary source of contamination in cleanrooms. Cleanrooms are designed to aid in the protection of the items being manufactured from environmental contaminants as much as possible. To protect the items being manufactured from human contamination, special gowning requirements are necessary. This is part 1 of a two-part series.
Cleanroom Gowning Programs Compliant With EU GMP Annex 1
Get more Cell & Gene insight with our FREE newsletter sign me up Discovery Trials Regulatory Outsourcing Commercialization Guest Column | December 15, 2022 By Crystal M. Booth, PSC Biotech Humans are the primary source of contamination in cleanrooms. Cleanrooms are designed to aid in the protection of the items being manufactured from environmental contaminants as much as possible. To protect the items being manufactured from human contamination, special gowning requirements are necessary.
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
Guest Column | December 1, 2022 By Crystal M. Booth, PSC Biotech Humans are the primary source of contamination in cleanrooms. Cleanrooms are designed to aid in the protection of the items being manufactured from environmental contaminants as much as possible. To protect the items being manufactured from human contamination, special gowning requirements are necessary. This is part 1 of a two-part series.
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
Guest Column | December 1, 2022 By Crystal M. Booth, PSC Biotech Humans are the primary source of contamination in cleanrooms. Cleanrooms are designed to aid in the protection of the items being manufactured from environmental contaminants as much as possible. To protect the items being manufactured from human contamination, special gowning requirements are necessary. This is part 1 of a two-part series.
Cleanroom Gowning Programs Compliant With EU GMP Annex 1 Original
Get more Bioprocess insight with our FREE newsletter sign me up Guest Column | December 15, 2022 By Crystal M. Booth, PSC Biotech Humans are the primary source of contamination in cleanrooms. Cleanrooms are designed to aid in the protection of the items being manufactured from environmental contaminants as much as possible. To protect the items being manufactured from human contamination, special gowning requirements are necessary. This is part 2 of a two-part article.
06.09.22 -- Essential Components Of A Sterility Assurance Program
By Crystal M. Booth, PSC Biotech The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.
11.11.21 -- The Essential Components Of A Sterility Assurance Program
By Jayet Moon, Veronica Stephens, and Kylee Rogers In Part 1 of this two-part series, the authors presented a method by which benefit-risk analysis can be objectively carried out to arrive at a benefit-risk ratio. This method can be applied to any medical therapy, and this article (Part 2) provides a very relevant and contemporary example of how it can be used to calculate COVID-19 vaccine benefit-risk. By Crystal M.
11.06.21 -- New Plug-And-Play Guidances: Computerized Systems Validation And Audit Trail Requirements
By Brent Lieffers By Sushma A. Ogram By Jorge L. Escobar Ivirico and Ma Sha By Jonathan Kirby, Alison Rees-Manley, et al. By Kristeena Wright, Ph.D., Linda Buck, et al. By Karen Lauxmann CCRM Cytiva Custom Sensors & Technology MyManifold Minebea Intec Catalent Cygnus Technologies Inc. Thermo Fisher Scientific Bioproduction Thermo Fisher Scientific MilliporeSigma Thermo Fisher Scientific
11.03.21 -- The Essential Components Of A Sterility Assurance Program
By Crystal M. Booth, PSC Biotech The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.
10.22.21 -- Essential Components Of A Sterility Assurance Program
Article | By David Butcher, MasterControl, Inc. The global business disruption caused by COVID-19 has exposed weaknesses in manufacturing. In this article, we discuss some production challenges revealed by COVID-19, and reasons to digitize. Article | By Jason Ott, Flow Sciences Inc. Engineering controls designed to mitigate exposure and create separation between the operator and toxic materials are available in many forms, all with their own unique advantages and risks.
The Essential Components Of A Sterility Assurance Program
By Crystal M. Booth, PSC Biotech Sterility assurance is a level of confidence that a particular product or unit that is purported to be sterile is sterile. Sterility cannot be demonstrated without the destruction of every unit of product produced. Therefore, sterility assurance is achieved through multiple practices and procedures. This article discusses the different variables of contamination control that help to increase confidence in sterility assurance.
The Essential Components Of A Sterility Assurance Program
By Crystal M. Booth, PSC Biotech Sterility assurance is a level of confidence that a particular product or unit that is purported to be sterile is sterile. Sterility cannot be demonstrated without the destruction of every unit of product produced. Therefore, sterility assurance is achieved through multiple practices and procedures. This article discusses the different variables of contamination control that help to increase confidence in sterility assurance.
The Essential Components Of A Sterility Assurance Program
By Crystal M. Booth, PSC Biotech Sterility assurance is a level of confidence that a particular product or unit that is purported to be sterile is sterile. Sterility cannot be demonstrated without the destruction of every unit of product produced. Therefore, sterility assurance is achieved through multiple practices and procedures. This article discusses the different variables of contamination control that help to increase confidence in sterility assurance.
The Essential Components Of A Sterility Assurance Program
By Crystal M. Booth, PSC Biotech Sterility assurance is a level of confidence that a particular product or unit that is purported to be sterile is sterile. Sterility cannot be demonstrated without the destruction of every unit of product produced. Therefore, sterility assurance is achieved through multiple practices and procedures. This article discusses the different variables of contamination control that help to increase confidence in sterility assurance.
04.28.21 -- Decentralized Cell Therapy Production In Practice
By Matthew Pillar, editor, Bioprocess Online Distributing the manufacture of autologous cell therapies to clinical and hospital settings to minimize time, cost, and logistics challenges is a popular conversation in biopharma circles. While many discuss it, Dr. Helen Sabzevari’s upstart biopharma Precigen is doing it. By Crystal M.
04.22.21 -- Tools And Best Practices For Trending Environmental Monitoring Data
Article | By Cheryl Abernathy and Bryan Sasbon, Ropack Pharma Solutions Using quality risk management (QRM) gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.
04.15.21 -- An Introduction To Trending In Environmental Monitoring Programs
Newsletter | April 15, 2021 By Crystal M. Booth, PSC Biotech Trending environmental monitoring (EM) data are a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, I look first at the regulations and guidelines around EM.
Tools And Best Practices For Trending Environmental Monitoring Data
By Crystal M. Booth, PSC Biotech Environmental monitoring (EM) trending is an essential component of the EM program and can be used to evaluate the overall health of the facility in terms of microbial control. EM trending should be clearly defined within the company to ensure that the data is evaluated consistently. Part one of this series looked at the regulations and guidelines around EM.
Tools And Best Practices For Trending Environmental Monitoring Data
By Crystal M. Booth, PSC Biotech Environmental monitoring (EM) trending is an essential component of the EM program and can be used to evaluate the overall health of the facility in terms of microbial control. EM trending should be clearly defined within the company to ensure that the data is evaluated consistently. Part one of this series looked at the regulations and guidelines around EM.
An Introduction To Trending In Environmental Monitoring Programs
By Crystal M. Booth, PSC Biotech Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if a facility is in a state of microbial control and relay the environmental monitoring data to facility management in a meaningful format. In this two-part article exploring environmental monitoring trending, I look first at the regulations and guidelines around EM.
11.11.20 -- Foundations Of Biopharma Finance With Smital Shah
Newsletter | November 11, 2020 Smital Shah brings a trifecta of chemical engineering, consulting, and finance experience earned at heavyweight companies JP Morgan, Leerink, and Gilead to her role at clinical-stage RNA therapy biotech ProQR Therapeutics. We sat down for a deep conversation on the recipe for successful business and finance operations in an emerging biopharma organization. By Crystal M.
10.27.20 -- COVID-19 Vaccine Manufacturing Challenges Spark Surge In Outsourcing Deals
Newsletter | October 27, 2020 By Fiona Barry, associate editor, PharmSource GlobalData As the pharma industry scrambles to develop one or more viable COVID-19 vaccines, the greatest hurdle to immunizing the world’s population is the manufacture of billions of doses in parallel. In response to this challenge, vaccine developers are signing an unprecedented number of outsourcing agreements with CMOs and other service providers. By Crystal M.
10.20.20 -- Does Your Pre-COVID Data Governance Pose A Threat To Data Integrity?
Newsletter | October 20, 2020 By Kip Wolf, X-Vax Technology Pandemic disruption presents a clear and present danger to data integrity. Assessment of agreed data standards, confirmation of conformance to filed information, and general attention to details may be compromised in the rush to gather, analyze, and understand pandemic-related information. By Crystal M. Booth, PSC Biotech This is part two of a three-part article on quality agreements.
A Quality Agreement Primer: What To Include & Who To Assign It To
By Crystal M. Booth, PSC Biotech With many companies utilizing contract manufacturing and contract laboratories, quality agreements are extremely important. Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements.
A Quality Agreement Primer: What To Include & Who To Assign It To
By Crystal M. Booth, PSC Biotech With many companies utilizing contract manufacturing and contract laboratories, quality agreements are extremely important. Part one of this three-part series on quality agreements discussed identifying key risks in partnering with contract companies and working with vendors. Part two explored the regulations and enforcement activities associated with quality agreements.
10.13.20 -- A Quality Agreement Primer: Managing Risk When Working With Contractors
By Crystal M. Booth, PSC Biotech This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met. Part one discusses identifying key risks in partnering with contract companies and working with vendors. By Herman F. Bozenhardt and Erich H. Bozenhardt Our industry depends on a wide spectrum of equipment suppliers that provide our manufacturing systems, utility systems, and environmental systems.
A Quality Agreement Primer: Reviewing Regulations & Enforcement Activity Original
By Crystal M. Booth, PSC Biotech With many companies utilizing contract manufacturing and contract laboratories, quality agreements are extremely important. This is part two of a three-part article on quality agreements. Part one discussed identifying key risks in partnering with contract companies and working with vendors. This second part explores the regulations and enforcement activities that apply to quality agreements.
A Quality Agreement Primer: Managing Risk When Working With Contractors
By Crystal M. Booth, PSC Biotech With many companies utilizing contract manufacturing and contract laboratories, quality agreements are extremely important. A quality agreement defines the quality parameters as well as who is responsible for those parameters. This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met.
A Quality Agreement Primer: Managing Risk When Working With Contractors Original
By Crystal M. Booth, PSC Biotech With many companies utilizing contract manufacturing and contract laboratories, quality agreements are extremely important. A quality agreement defines the quality parameters as well as who is responsible for those parameters. This is part one of a three-part series that explores quality agreements, regulations, guidelines, and working with vendors to ensure quality expectations are met.
05.11.20 -- Bioprocess With The Bozenhardts: Facilities Design Trends
Newsletter | May 11, 2020 On this episode, we kick off the series with a discussion on what's driving the move toward smaller, more agile production facilities, the role these trends play in your strategy, physical space, capital, HR, and utilities impacts you'll need to consider to stay ahead of the curve, and a whole lot more. By Crystal M. Booth, PSC Biotech During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds.
04.28.20 -- Applying Aseptic Practices To Protect Yourself From COVID-19
Article | By Tristan Wilkins and Jeffrey Robinson, Lonza Pharma & Biotech Meeting the needs of the modern biomanufacturing landscape requires a combination of technology and digital solutions working together to effectively and efficiently meet your goals. Article | By Adam Christensen, NuAire, Inc. This guide will help lab managers understand risks and best practices as they develop training for CO2 incubator users and establish a preventive maintenance program and setup criteria.
Applying Aseptic Practices To Protect Yourself From COVID-19
By Crystal M. Booth, PSC Biotech During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. That is the best defense to stay healthy. There are lots of tips circulating on media outlets to stay healthy; essential household and basic first-aid supplies are hard to find; and people are dying at frightening clips. This is my first time experiencing a global pandemic and although I imagine it could be worse, it is still intense.
Applying Aseptic Practices To Protect Yourself From COVID-19
By Crystal M. Booth, PSC Biotech During this COVID-19 pandemic, we have all heard it: Wash your hands with soap and water for at least 20 seconds. That is the best defense to stay healthy. There are lots of tips circulating on media outlets to stay healthy; essential household and basic first-aid supplies are hard to find; and people are dying at frightening clips. This is my first time experiencing a global pandemic and although I imagine it could be worse, it is still intense.
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