This new EMA guideline will become effective on January 1, 2022. It describes the information that should be presented in the quality part of a marketing authorization dossier for a medicinal product when it is used with a medical device and/or as part of a medical device. Medicinal products are similar to "combination products" referred to by the US FDA.
- Shaping A System That Enables Patients To Access High-Cost Cell & Gene Therapies
- 10 Critical Validation Parameters For Microbiological Experiments
- What To Expect From A Remote Inspection -- & How To Navigate It
- Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation
- The 8-Step Checklist To Write Effective Investigation Reports
- FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
- Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book
Why Should We Rescue The Legislative Intent Of The BPCIA?
What happens when regulatory ambiguity displaces sound scientific guidance, deterring the legislative intent of Congress? This is precisely the situation regarding the FDA changing the regulatory rules of the road regarding a biosimilar’s strength versus its potency.
10 Critical Validation Parameters For Microbiological Experiments
In studying a microbiological method, different validation parameters require assessment. These are variables or factors that can be controlled, changed, or measured in the experiment. This article outlines the key parameters to consider.
What To Expect From A Remote Inspection -- & How To Navigate It
Regulators have moved toward remote inspections since the pandemic began, and this is likely to continue. This article presents an overview of the remote inspection process and provides advice on how to prepare for and deal with the inspection on the day, as well as how to respond to any concerns raised following the audit.
Selecting The Best Human Factors Method For Your Medical Or Drug Delivery Device Evaluation
A robust human factors process has become critical to product optimization and market competitiveness for medical devices and drug delivery devices, but not all companies have the resources, funding, or time to conduct such user studies. This article from Genentech's head of human factors engineering examines the three major categories of evaluation that you should consider, the pros and cons of each, and how to select study participants.
The 8-Step Checklist To Write Effective Investigation Reports
It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.
FDA Releases Guidance On CMC Changes To An Approved Application: Certain Biological Products
At the end of June, the FDA released a new guidance to assist applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application. This article summarizes the guidance.
Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book
The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.
How To Enhance “Operational Learning” In Biopharma
According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.
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Key Equipment Sourcing Strategies For CMOs
There are many reasons that a product-owner elects to outsource product manufacturing to a toll or contract manufacturer.
Single-Use Platforms Accelerate Viral Vaccine Development, Manufacturing10/31/2019
Analysts predict the vaccine market could grow at as much as 10.3 percent through 2024 (CAGR). Single-use platforms might be pivotal to meeting that demand.
Microbial Control And Monitoring In Aseptic Processing Cleanrooms4/27/2021
Environmental Monitoring (EM), particularly in pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods. This paper reviews how the data originating from these EM components provides critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.
The Role Of CDMOs In Cell And Gene Therapy Process Development8/5/2020
This article highlights areas where CDMOs can help companies get started in CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.
An Introduction To High Voltage Leak Detection (HVLD) Technology4/8/2021
It is understood that no matter how carefully a product has been prepared, it would still be unsafe for human use if the container has a pinhole, a crack or a defective seal. There are a variety of methods widely used in the detection of pinholes, cracks and defective seals in containers however a majority are destructive causing the loss of good product and packaging components. Read more to learn why the High Voltage Leak Detection (HVLD) system is totally free from these shortcomings and has additional advantages for ensuring seal integrity.
Micro-Flow Imaging Enables Cutting Edge Biopharmaceutical Research1/26/2021
Protein aggregation and the formation of subvisible particles can significantly impact the safety and efficacy of biopharmaceuticals. Therefore, protein aggregation and subvisible particle content must be carefully monitored during in-process and final product development. Micro-Flow Imaging™ (MFI), a powerful system to analyze protein aggregates and other subvisible particles in your samples and can assess the stability of antibody-based biotherapeutics in response to stress
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Since the pandemic began, we’ve seen disruptions to regulatory inspection and enforcement. What has this looked like, and what has been the impact to the pharmaceutical industry? In this e-book, we dive in specifically to the regulatory agencies of the FDA in the U.S. and the MHRA in the UK.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.