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05.25.21 -- Are You Approaching LIMS Validation Correctly?

05.25.21 Are You Approaching LIMS Validation Correctly?

Sanofi wanted to upgrade from an existing batch chromatography process to the BioSMB multicolumn format, then scale up that process to a continuous perfusion run. This case study details the real-world results.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Industry Insights ....

Dominic Hyde , Stephen Natoli , Alex Nancekievill , Kashif Ghaffar , Jason Osman , Peter Poechlauer , John Mcguire , Todd Andrews , Gabriela Mikhaiel , Jeff Tremain , Lonnie Barish , Matthew Jones , Mike Dingle , Bora Pharmaceuticals , White Paper Alconox Inc , Nidec Group , Natoli Engineering Company Inc , Qa Ajinomoto Bio Pharma Services , Pharma Services , Thermo Fisher , Per Hammer , Natoli Engineering Company , Coperionk Tron , Ajinomoto Bio Pharma , Fisher Clinical , ஆதிக்கம் செலுத்தும் ஹைட் ,

04.29.21 -- COVID-19's Impact On Outsourced Small Molecule Manufacturing

04.29.21 COVID-19 s Impact On Outsourced Small Molecule Manufacturing

Catching up to the paradigm shift in optimizing, scaling up, and manufacturing plasmids is crucial for clinical to commercial program success for gene therapies and vaccines. With an increased demand for plasmids for targeted gene therapeutic delivery, partnering with a CDMO equipped with the capacity, expertise, and equipment for plasmid DNA production is critical to ensuring a stable therapeutic supply. Join Aji Bio-Pharma to learn about methodologies to ensure effective production and increase the likelihood of market success.
Featured Editorial
By ISR Reports
In Q4 2020, ISR surveyed 249 sponsors who outsource small molecule manufacturing to learn if their company experienced outsourced manufacturing complications as a result of the COVID-19 pandemic. Small molecule drug substance outsourcers were slightly more likely to report complications t ....

David Bastie , John Boehm , Brent Bushnell , George Hlass , Peter Poechlauer , Andreas Stolle , White Paper Alconox Inc , Article Ropack Pharma Solutions , Pharma Services , Poster Pfeiffer Vacuum Inc , Thermo Fisher , Dwayne Hull , Ropack Pharma , Pfeiffer Vacuum , ஜான் போஹம் , ப்ரெண்ட் புஷ்னெல் , ஆண்ட்ரியாஸ் ஸ்டொல்லே , பார்மா சேவைகள் , போஸ்டர் ஃபைஃபர் வெற்றிடம் இன்க் , தெர்மோ மீனவர் , வேன் ஹல் , ஃபைஃபர் வெற்றிடம் ,

01.28.21 -- When Pharmaceutical Automation Projects Fail: Averting Disaster Through Risk Assessment

01.28.21 When Pharmaceutical Automation Projects Fail: Averting Disaster Through Risk Assessment

With the spread of SARS-CoV-2 (COVID-19) intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring life-saving drugs to market. Attend this webinar to learn more about bringing life-saving drugs to market faster without impacting product quality, safety, or efficacy and the impacts and comparisons of classic platforms vs. new-generation platforms. And more!

By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Automation does not always result in success, and poor automation can be as damaging to the pharmaceutical organization as no automation at all. This article addresses what happens when automation goes wrong and how mistakes can be avoided by adopting a risk-centric approach. ....

Dominic Hyde , David Bastie , Samsung Biologics , Josefin Bolik , Tony Pidgeon , Peter Poechlauer , Omara Salman , Adam Christensen , Yves Massicotte , Anthony Newcombe , Oliver Hardick , Tim Russell , George Hlass , Jarv Campbell , Andreas Stolle , Webinar Alconox Inc , Ropack Pharma Solutions , Article Promega Corporation , Nuaire Inc , Thermo Fisher , Pfizer Centreone Contract , Ropack Pharma , Ken Green , Meissner Filtration , Sartorius Stedim , ஆதிக்கம் செலுத்தும் ஹைட் ,

01.07.21 -- Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies

01.07.21 Facility Engineering, Design, And Construction Tips For Up-Start Biotech Companies

This report helps small and emerging biopharma companies make more informed CMO decisions, and helps CMOs optimize operational and marketing strategies to better accommodate this segment. Findings are based on 93 service encounters from 42 respondents involved in outsourced small molecule API projects in the past 18 months. Learn more here.
Featured Editorial
By Herman F. Bozenhardt and Erich H. Bozenhardt
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedules, and maintain quality. ....

Kevin Queensen , Samsung Biologics , Ray Ryan , Monicam Commerford , Nick Armstrong , Peter Poechlauer , Gabriela Mikhaiel , David Koechlein , Steve Janz , Derek Pendlebury , Sundeep Sethia , Matthew Jones , Patti Cuevas , Shawn Watson , Matthias Wiehn , Amy Trotch , Catalent Bloomington , Maria Lloris , Bernat Busquet , Robertk Haugen , Julie Stiller , Bryan Braxton , Justin Carbungco , Catalent Biologics , Kieran Coffey , Case Study Seeq Corporation ,

12.17.20 -- FDA FY2020 Drug Inspection Observations And Trends

12.17.20 FDA FY2020 Drug Inspection Observations And Trends

ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may pay $40, whereas a 45-minute phone interview may pay $150) and they get to choose which research opportunities to participate in. Apply here.
Featured Editorial

This article presents the FDA s most recent publication of GMP drug inspection data, which address drug inspections conducted in FY2020. We examine data from FY2020 and evaluate five years worth of trends in drug GMP inspection enforcement. ....

Ted Tharp , Abdelaziz Toumi , Jessica Mueller Albers , Peter Poechlauer , Martin Gonzalez , Ian Whitehall , Lonza Biologics , Charles Ross , Gibco Efficientfeed , Jeff Tremain , Christine Banaszek , Qa Lonza Pharma , Andreas Stolle , Case Study Almac Group , Case Study Flow Sciences Inc , Poster Micromeritics Instrument Corporation , Case Study Asahi Kasei Bioprocess America Inc , Case Study Dec Group , Evonik Corporation , White Paper Alconox Inc , Pharma Services , Son Company , Thermo Fisher , Pfizer Centreone Contract , Dwayne Hull , Jon Best ,