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.
- 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
- How To Enhance “Operational Learning” In Biopharma
- Emerging Biopharma: Your Next 2 Geographic Markets To Tackle After The US
- Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances
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.
Emerging Biopharma: Your Next 2 Geographic Markets To Tackle After The US
While the majority of the world’s drug development and innovation are underwritten by the United States, emerging drug developers should not overlook these two major regions of the world that represent volume, profit, ingenuity, and growth.
Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances
In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.
5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals
Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation.
PHARMA ONLINE WHITE PAPERS
Introduction To Mass Transfer In Single-Use Bioreactors
Mass transfer in single-use bioreactors is complex and often misunderstood, yet critical to the growth of cells in culture, This paper aims to elucidate the standard mass transfer model.
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.
Toxic Treatments: Controlling Exposure Risks In ADC Manufacturing1/23/2020
The potency and effectiveness of the ADCs are dependent upon engineered nanoparticles (ENPs), but little is known about the environmental and human health hazards posed by ENPs.
Preparing For Your CDMO Selection Process10/1/2019
Finding the CDMO that is right for your company and project can be a daunting task, particularly if this is your first time outsourcing. Don't be unprepared from the outset of your search.
Meeting Diverse Biologic Pipeline Process Development Challenges9/10/2020
The biopharma manufacturing industry has been evolving at an unmatched pace. Understanding and managing diverse molecule challenges is key to ensuring they reach patients safely and efficiently.
Key Equipment Sourcing Strategies For CMOs1/16/2020
There are many reasons that a product-owner elects to outsource product manufacturing to a toll or contract manufacturer.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
In this roundtable Q&A, industry experts from AstraZeneca, Takeda, Biogen, and NSF Health Sciences share insights on important topics related to human performance in pharmaceutical operations — offering insight into how forward-thinking organizations treat “human error” in the workplace.More Content Collections
PHARMA ONLINE PRODUCTS & SERVICES
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.