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.
- Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book
- How To Enhance “Operational Learning” In Biopharma
- Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances
- 5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals
- Emerging Technologies In The Delivery Of Proteins & Peptides
- New US Legislation Creates Momentum For Biosimilars
- Data Integrity In Supply Chain Risk Management During Zero Trust
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.
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.
Emerging Technologies In The Delivery Of Proteins & Peptides
The limited ability to selectively deliver new drug molecules in the forms of peptides and proteins remains a significant challenge. Therefore, new materials and manufacturing techniques are emerging to meet the challenges associated with the formulation and delivery of biopharmaceuticals and pharmaceuticals.
New US Legislation Creates Momentum For Biosimilars
Most biosimilars (follow-on biologic products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.
Data Integrity In Supply Chain Risk Management During Zero Trust
Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.
BIOSIMILAR WHITE PAPERS
QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1
Quality Risk Management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its lifecycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.
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.
Considerations For Upstream Biologic Development11/12/2019
A biologic candidate's path from DNA to drug-in-vial is long and complex. These considerations might simplify and improve the economics of the process, helping molecules get to market as quickly as possible.
Considerations For Improving Outcomes In Biopharmaceutical Process Development8/12/2020
In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.
Not Everyone Loves Surprises: Know Your ADC’s Critical Quality Attributes2/21/2020
Combatting the challenges of developing and manufacturing ADCs requires robust product characterization throughout all phases of development.
Virus Safety For Continuous Processing9/5/2019
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.