The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because you'll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more! Here's what you can do to position yourself for success.
- How To Use DMF Content To Support Your Application To The FDA
- No, Biologics Are Not Natural Monopolies
- Are You Approaching LIMS Validation Correctly?
- Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs
- Decentralized Cell Therapy Production In Practice
- Inside San Jose’s Uncommon Biotech Accelerator
- An Analysis Of The Gene Therapy Viral Vector Landscape
Thermo Fisher To Acquire PPD
In an effort to create greater customer and shareholder value, Thermo Fisher Scientific has announced plans to acquire clinical research organization PPD for a cash purchase price of $17.4 billion. The purchase will also include the assumption of approximately $3.5 billion of net debt.
Computational biology services provider Compugen leveraged its proprietary technology to reposition itself as a therapeutic discovery and development company with a pipeline of eight solid tumor oncology candidates – six of them in the clinic. CEO Anat Cohen-Dayag, Ph.D. led the transition, and she shared the strategies employed during the pivot with BioProcess Online.
Amolyt Pharma founder and CEO Dr. Thierry Abribat credits his company’s fast clinical pace to the assemblance of a veteran drug development team that's learned from clinical and commercial successes. Here’s some of his advice for the leaders of new & emerging biopharmas.
Led by Dr. Mark Allen and backed by heavyweights like Peter Diamandis, M.D. and Tony Robbins, biopharma startup Elevian is charting the CMC and regulatory path for Growth Differentiation Factor 11 to make a therapeutic play in a host of age-related diseases.
Uvax Bio’s unconventional approach brings a heretofore ignored physical component to vaccine design. Co-founders Dr. Ji Li and Jiang Zhu share why they think their platform is poised to revolutionize vaccine development, manufacturing, and distribution.
How To Use DMF Content To Support Your Application To The FDA
A drug master file (DMF) is a voluntary regulatory application submitted to the U.S. FDA. It is used to provide confidential detailed information about the manufacturing, processing, packaging, and storing of APIs and/or human drugs. What are the types of DMF submissions, what is involved, and how does the FDA evaluate your submission?
No, Biologics Are Not Natural Monopolies
Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.
Are You Approaching LIMS Validation Correctly?
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Using System Risk Structures To Understand And Balance Risk/Benefit Trade-offs
The ICH 31000 guidance defines a risk as the “impact of uncertainty on objectives.” As a follow-up to his article on why we should replace the RPN with the adjusted risk likelihood (ARL), Mark Witcher describes how system risk structures can be used to simultaneously understand and manage both risks and benefits.
An Analysis Of The Gene Therapy Viral Vector Landscape
Over the last five years, multiple gene therapies have been approved by regulatory agencies and a bolus of late-stage pipeline assets are approaching the market. However, as the first gene therapies began to post early wins, several challenges have emerged. This article discusses the landscape of the viral vector sector.
Manufacturing Therapeutics In Hospitals: Re-envisioning The Bioprocessing Paradigm
Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. However, advanced therapy medicinal products (ATMPs) are changing how we think about how we deliver therapies. The success of these new and complex therapies requires partnership with those administering them, which is a new paradigm.
Making Sense Of Antibody Epitope Claims
Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.
How to Ensure Your Quality Culture Assures Data Integrity
One solution to ensuring data integrity is to automate the process, essentially removing the human element. But not all instances of data generation/capture can or should be automated. With humans – our team members – engaged in data generation/capture, the quality culture is a major pathway to assuring our data have integrity.
BIOPROCESSING WHITE PAPERS
Using Single-Use Connectors To Increase The Integrity Of Closed Systems
It is critical the single-use sterile connectors you select meet the sterility and reliability needs of your application, as minimizing the threat of contamination using a closed system is essential.
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.
Quality Matters – SEC Analysis For Antibody Aggregates10/25/2019
Size exclusion chromatography is the go-to analytical method for therapeutic protein drugs. This article describes the factors affecting the reproducibility of columns and how you can minimize column variation.
Telltale Signs You’re With The Wrong CDMO4/27/2020
Is your CDMO an asset or a hindrance? This article explores 10 red flags that signal your parter isn't carrying its weight on your journey to commercialization.
Reducing The Risk During Cell And Gene Therapy Development And Manufacturing5/13/2020
While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.
Reliable Osmolality Testing Of High Concentration mAb Formulations12/17/2020
Osmolality testing has several bioprocessing applications, and new use cases are constantly emerging. This paper evaluates two osmometers for measuring concentrated protein formulations.
BIOPROCESS ONLINE CONTENT COLLECTIONS
One of the many lessons learned in the wake of the COVID-19 pandemic is that we can move fast. Really fast. Much faster than we ever thought possible. But will it last? Have the efficiencies, synergies, and collaborations forged over the past 16 months set new precedents for the way the FDA works, and new expectations on how biopharma companies work with the agency? In this e-book, we’ve compiled recent assessments from the foremost FDA consultants and analysts in the space.More Content Collections