A plug-and-play approach can significantly impact how we design, build, and operate biopharmaceutical facilities. Yet, with such a new and innovative development, there are many challenges for industry to adopt the approach. This article summarizes two recently released BioPhorum standards:_ Plug-And-Play Computerized Systems Validation Strategy_ and _Plug-And-Play Audit Trail Requirements_.
- An Introduction To Biopharma Facility Design & Layout
- COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
- A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
- A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
- Is A SPAC The Right Option For Your Emerging Biotech?
- Forging A New Path Forward in Manufacturing Genetic Medicines
- 3 Reasons Why Medtech & Digital Healthcare Companies Should Consider Direct-To-Cloud Connectivity for IoMT
An Introduction To Biopharma Facility Design & Layout
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
COVID-19 Spurs Growth Of China’s Domestic Bioprocessing Suppliers
Just as the U.S. and European bioprocessing supply systems have seen more robust growth than ever before, China’s domestic demands for single-use bags, cell culture media, and purification resins are all on the rise. BioPlan’s Top1000Bio database of global bioprocessing facilities has tracked industry capacity and employment growth over 15 years.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part 2 — COVID-19 Vaccine Benefit-Risk
In Part 1 of this 2-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.
A Quantitative Benefit-Risk Analysis & Benefit-Risk Ratio Using Real World Data: Part I
This article introduces a novel model of benefit-risk by taking a bottom-up approach using the _risk of the therapy_ and comparing it to _risk of no therapy_ to quantify risk and benefit with the same scale. This overview is relevant not only to the pharmaceutical and biotech industries, but also the medical device industry.
Is A SPAC The Right Option For Your Emerging Biotech?
As biotech and emerging pharma companies weigh their options for raising capital, the popularity of the special purpose acquisition company (SPAC) has surged, with a 175% increase in announced SPAC M&As seen between 2019 and 2020. This article examines the considerations you should make when weighing if a SPAC is the right option for your company.
Forging A New Path Forward in Manufacturing Genetic Medicines
While the past decade’s focus on scientific advances has accelerated the advancement of genetic medicines, including gene and cell therapies, manufacturing is vital to product quality, safety, efficacy and clinical trial and commercial supply. In the case of adeno-associated virus (AAV)-based gene therapy and gene editing product development, manufacturing is no simple task. As the industry advances these genetic medicines, manufacturing is also ramping up, and with it optimization and efficiencies of scale. Since the industry is still maturing, and manufacturing know-how is often kept proprietary, companies must learn, adapt, and master novel innovations as well as challenges on their own.
3 Reasons Why Medtech & Digital Healthcare Companies Should Consider Direct-To-Cloud Connectivity for IoMT
A critical part of the digital health ecosystem, wireless connectivity is a key enabler for medical devices that can be used by patients at home and on the move. For example, connected drug delivery devices enable pharma companies to offer remote monitoring, while wearable sensors enable continuous remote diagnostics. This article explains 3 reasons why you should consider direct-to-cloud connectivity for your product.
Is The FDA About To Reclassify Your Drug Product As A Device?
Until Oct. 8, 2021, the FDA is seeking public comment on its plans to transition some drugs to device status. The agency's intended implementation will affect not only new products meeting both drug and device statutory definitions in connection with the approval process but also existing products on the market that may have been improperly classified as drugs.
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Can mRNA Disrupt The Biopharma Industry?
mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.
Single-Use Systems For Vaccine Manufacturing10/29/2019
Next-gen vaccines will leverage recombinant approaches and intensified single-use systems (SUS) to increase capacity at reduced costs, but SUS suppliers will need to overcome regulatory challenges.
Analysis Of Laboratory Nitrile Gloves: From Pores To The Surface10/7/2020
The humble rubber glove is usually the first line of protection for any person working with toxic, hazardous and contagious materials or environments. While everyone agrees on their universal use, very little attention is paid to the type of material, surface topography or pore size distribution of the glove itself. Here we describe an approach where the use of multiple techniques has enabled a complete physical characterization of the rubber glove material.
Evaluating The Container Closure Integrity Of A Vial Using Headspace Gas Ingress Methods3/18/2020
To ensure patient safety, pharmaceutical products must be kept properly packaged prior to use. Proper packaging prevents ingress of contaminants. Unfortunately, these contaminants are not always visible to the human eye and container closure integrity (CCI) tests must be performed to ensure the package has not been compromised. One way to test for proper CCI is to analyze the headspace gas composition of the vial.
Water Activity Measurements And Microbial Contamination In Pharmaceutical Products6/19/2020
Non-sterile pharmaceutical products are subject to microbiological examination prior to release and during stability testing. While the tests described in these chapters cannot be eliminated from protocol completely, USP <1112>, Application of Water Activity Determination to Nonsterile Pharmaceutical Products, suggests that water activity determination can be used to reduce the need for frequent microbial limit testing and screening.
Demystifying Performance Testing: Strategies To Qualify Combination Products11/30/2020
Demonstration of fit-for-purpose for a drug-device combination product requires demonstration of system performance that meets regulatory requirements. This article presents a best practice strategy for performance testing. It starts with a thorough understanding of applicable regulations and guidances. Following this, performance risks are identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses. Next, a test plan based on accepted standards is designed and executed, considering highest risk failure modes first.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Our latest e-book explores efforts to pay closer attention to how your company’s culture and operations ensure the completeness, consistency, and accuracy of data - AKA data integrity. Such data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA), according to the FDA. Similarly, data must be complete, consistent, and accurate throughout the data life cycle, according to the MHRA and the Pharmaceutical Inspection Co-operation Scheme.More Content Collections
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LIFE SCIENCE CONNECT SPOTLIGHT JOB OPENING: TARSUS
Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.
Sound interesting?Read the Job Posting to learn more.