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. Part 1 of this series looked at the regulations and guidelines around EM. This article discusses tools and best practices for using the trends to ensure that an efficient environmental monitoring program is established.
- Rating Risk Events: Why We Should Replace The Risk Priority Number (RPN) With The Adjusted Risk Likelihood (ARL)
- An Introduction To Trending In Environmental Monitoring Programs
- FDA Inspections: Are Changes On The Horizon?
- Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across
- Life Sciences Dealmaking Aims At Early Stages Amid COVID-19
- Complying With Batch Release: Auditing Electronic Batch Records
- Can GDF11 Address Aging, One Disease At A Time?
EDITOR'S DESK
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![Drawing Vaccine]( "Regulatory Approval Trends In The Age Of COVID-19")
Regulatory Approval Trends In The Age Of COVID-19The FDA is approving more therapies at a faster pace, but it’s not all COVID, all the time. Allan Shaw helps us expose regulatory approval trends, and the implications of those trends on the biotech business.
NeuBase Therapeutics CEO Dr. Dietrich Stephan discusses the important role computational drug discovery plays as we emerge from what he characterizes as “a decades-long, multi-billion-dollar chemical engineering escapade with a very low success rate to find one drug.”
Celyad Oncology CEO Filippo Petti digs in on differentiating his company’s approach to developing and manufacturing allogeneic cell therapies for several oncology indications, including the company's technology platform and scale-up strategies in Celyad’s Belgium-based clinical manufacturing facility.
Project Farma and Precision ADVANCE leaders Anshul Mangal and John Khoury address the biotherapeutic process and manufacturing talent gap, and propose resources to bolster global skill and capacity. Read about it, or watch the video of our conversation here.
Lineage Cell Therapeutics CEO Brian Culley is inspired by the speed and agility at which the biopharma industry—including the FDA—are working to get new cell therapies to market, despite the clinical disruptions of the day. With three clinical-stage candidates, here's how Culley and company are addressing those challenges.
GUEST COLUMNISTS
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![iStock-476187976]( "An Introduction To Trending In Environmental Monitoring Programs")
An Introduction To Trending In Environmental Monitoring ProgramsTrending environmental monitoring (EM) data is 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, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM.
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![Sunset]( "FDA Inspections: Are Changes On The Horizon?")
FDA Inspections: Are Changes On The Horizon?A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.
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![Meeting Teaching]( "Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across")
Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message AcrossBiosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.
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![shaking-hands]( "Life Sciences Dealmaking Aims At Early Stages Amid COVID-19")
Life Sciences Dealmaking Aims At Early Stages Amid COVID-19Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets.This article highlights takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals in 2020.
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![iStock-517341918 (1)]( "Complying With Batch Release: Auditing Electronic Batch Records")
Complying With Batch Release: Auditing Electronic Batch RecordsThis article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation.
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![iStock-856877300]( "Assessing CT-P13 SC’s Impact Across Indications")
Assessing CT-P13 SC’s Impact Across IndicationsThis is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.
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![iStock-1221576332]( "Medicare Braces For Expanded Use Of High-Cost CAR T-Cell Therapy")
Medicare Braces For Expanded Use Of High-Cost CAR T-Cell TherapyThe Centers for Medicare & Medicaid Services (CMS) established a new reimbursement rate for inpatient CAR T-cell delivery in 2021 designed to more closely reflect the true costs of care and address the financial losses experienced by many healthcare institutions. This article delves into details on this and also discusses another significant change for 2021.
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![Woman With Binoculars]( "FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch")
FDA’s 2021 Focus Areas Of Regulatory Science: 5 Trends To WatchThe FDA recognized that a new approach was required to keep pace with the rapid evolution of science and technology driving drug development, and it released the report Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) early in 2021 to identify and communicate areas requiring continued targeted investment. These five key elements deserve our attention.
BIOPROCESSING WHITE PAPERS
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![8 Ways That Osmolality Testing]( "8 Ways Osmolality Tests Improve Cell & Gene Process Dev, Manufacturing")
8 Ways Osmolality Tests Improve Cell & Gene Process Dev, ManufacturingCell and gene therapies have the potential to revolutionize incurable, debilitating, and often fatal diseases. This paper outlines eight emerging and novel uses for osmolality testing in advanced therapy production.
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Downstream Manufacturing Of Gene Therapy Vectors4/1/2021
The downstream manufacturing process takes the output from upstream operations and transforms it through multiple steps into a viable drug product ready for administration to patients. The major challenge in downstream processing is to maximize yield while meeting both product and impurity specifications. Viral vectors destined for clinical use must comply with regulatory standards for product safety and potency and this means contaminants must be removed and impurities controlled. This paper identifies challenges and opportunities to improve current operations and maximize yield.
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End-To-End Thinking During Drug Product Development10/7/2020
In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.
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Analyzing Product Formulation Using Raman Spectroscopy10/26/2020
Compare the dissolution rates and pellet fine structure of branded Sporanox® with three similar generic products marketed across the world all containing the same API itraconazole.
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Expanded Access And Commercial Packaging Strategies For Orphan, Niche, And Low-Volume Drugs7/20/2020
Most commercial contract drug packagers do not provide consistent scheduling for low-volume drugs, which creates supply challenges. In fact, a drug packaging delay can create a market shortage that triggers serious health consequences for patients who rely on the drug. This issue can arise with niche and orphan drugs, as well as any other drugs packaged in small volumes. Conversely, a clinical supply partner can provide packaging as needed, plus handle distribution for expanded access and general commercial needs. This summary describes low-volume drugs, examines commercial packaging and supply challenges, and explores potential solutions.
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Speed To Market: The Optimal Program For Your Candidate10/22/2020
With a variety of gene to IND programs on the market, it is important you carefully assess which program matches your technical expectations as well as your risk adversity profile.
BIOPROCESSING APP NOTES & CASE STUDIES
NEWSLETTER ARCHIVE
BIOPROCESS ONLINE CONTENT COLLECTIONS
As the initiative to combat the global pandemic continues to play out and consume supply chain resources, the fast-approaching requirements of the Drug Supply Chain Security Act (DSCSA) remain. To help biopharma supply chain pros juggle these equally high priorities, we've assembled a collection of columns on these supply chain considerations, authored by independent experts on the topics at hand. We trust you'll find their guidance valuable.
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- Gene Therapy Downstream Manufacturing, Scale-up And Best Practices
- Gene Therapy Upstream Manufacturing, Scale-up And Best Practices
- Freezing Biologics For Storage And Transport
- General Scale-Up Strategies: Commonalities Between Mammalian And Microbial Processes
- Implementing Single-Use Technologies In Formulation And Filling Of Vaccines