While risks can be reduced to a residual level, it is not possible to eliminate a risk entirely. Such risks are foremost about injury to the patient and to the user. Other associated risks may be to the environment or with any data collected. It is incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk posed by these devices.
- The Essential Components Of A Sterility Assurance Program
- An Introduction To Biopharma Facility Design & Layout
- 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?
- Is The FDA About To Reclassify Your Drug Product As A Device?
- FMEA Vs. System Risk Structures (SRS): Which Is More Useful?
The Essential Components Of A Sterility Assurance Program
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 for a holistic sterility assurance program needed for an aseptic manufactured product.
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.
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.
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.
FMEA Vs. System Risk Structures (SRS): Which Is More Useful?
In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
BIOSIMILAR WHITE PAPERS
Business Continuity Program: Maintain Operations During Crises
Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.
Accelerate Process Intensification For Viral Vaccine Manufacturing7/23/2020
This article details an integrated portfolio of technologies to facilitate process intensification of viral-based vaccines including SARS-CoV-2 vaccine candidates.
Standardizing Vein-To-Vein Logistics To Reach More Patients2/24/2020
Collaboration is key to solving data management and process variability challenges as stakeholders work towards a common goal—getting life-saving treatments to those who need them.
Ensuring Consistency In The Supply Of Cell Culture Media12/16/2020
This paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.
Embedding Your Drug Strategy Within A Solid Foundation For Success3/24/2020
This white paper looks at the set of trends inﬂuencing pharmaceutical development and manufacturing strategy today, and how these drivers are inﬂuencing new business models with outsourced partners.
Enabling Biologic Drug Delivery Of Volumes Beyond 1 mL7/22/2020
Delivery system manufacturers need to manage conflicting requirements and offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.