Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.
- 3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully
- Biopharma Facility Modular Design & Construction: Key Considerations
- A Practical Guide To Navigate The EU's Revised GMP Annex 1
- 5 Steps To Avoid Mismanaging Biopharma Grant Funds
- Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated
- Biotech 2016 To 2022 And A Look Ahead
- Attributable Data Integrity in Modern Biopharma Using ALCOA Principles
3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully
Small and midsize biotechs can no longer rely on traditional commercial models. Launching new drugs is one of the most critical phases in the product life cycle, and often these entities’ entire existence depends heavily on a successful rollout. This article shares trends and three strategies for success.
Biopharma Facility Modular Design & Construction: Key Considerations
In terms of facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain that standardized modules and components reach, the wider the benefits to the entire industry.
A Practical Guide To Navigate The EU's Revised GMP Annex 1
The EU's final version of the GMP Annex 1 is now published, and it's time to take action. This article shares a road map to navigate what is new and different, how to document your "known unknowns," and more. Quality risk management and a contamination control strategy will be key.
5 Steps To Avoid Mismanaging Biopharma Grant Funds
You've finally received the grant you need to make your biopharma business a reality. The tough part is over, right? Not exactly. If you mismanage your funds, you could end up on the government’s naughty list.
Replacing The MAC/MACO With The MSC: Rethinking How Cleaning Validation Limits Are Calculated
Two of the most commonly used terms used in pharmaceutical cleaning validation are the Maximum Allowable Carryover (MAC or MACO) and the Maximum Safe Carryover (MSC). This article provides the historical development of both terms and why we should replace the MAC/MACO with the MSC.
Biotech 2016 To 2022 And A Look Ahead
The last five years have been disruptive regardless of sector, yet biotech managed to weather the storm. This article looks at the past five years in the industry from a macro view and shares what biotech executives should consider in the months ahead.
Attributable Data Integrity in Modern Biopharma Using ALCOA Principles
This article is the first in a five-part series providing contemporary, practical, and useful examples of data integrity within each of the five traditional principles of ALCOA. This article centers on A: Attributable.
BIOSIMILAR WHITE PAPERS
Secure The Cell Therapy Supply Chain From Bench To Bedside
While current approaches can manage the existing volume of cell therapy shipments, scaling these treatments up and out will increase pressure on cryogenic logistics networks.
Optimizing Lipid Formulations For Targeted RNA-LNP Applications9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
QRM For Filter Integrity Testing: Complying With EMA's Future Annex 110/21/2020
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.
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 starts with applicable regulations and guidances, and then 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.
De-Risking Biosimilar Development With A Clinically Validated And Commercially Proven Disposable Autoinjector6/2/2022
Discover how a biopharmaceutical company can de-risk the launch process by choosing a suitable autoinjector technology and partner.
Bio4C ProcessPad 21 CFR Part 11 Compliance White Paper1/12/2021
Learn how Bio4C ProcessPad™ meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.