Small-scale models (SSMs) are widely used in the biopharmaceutical industry. These models are used for process development and optimization, scale-up, technology transfer, process characterization, process validation, and more. This article discusses the applications of the models, including viral clearance, quality oversight, and design considerations for justification of SSMs.
- Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise
- Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare
- FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
- 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
Biologics Clinical Research: The Year’s Best
Harry Selker, M.D. sits down with BioProcess Online for a candid discussion on the Clinical Research Forum’s work, its awards program that recognizes the year's best advances in clinical and translational research, and why that’s such an important structural element in the bridge between academia and industry.
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.
Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise
With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.
FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.
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.
BIOPROCESSING WHITE PAPERS
An Introduction To High Containment For Lyophilization Processes
This white paper explores the advantages and disadvantages of lyophilization as well as lyophilizer solution examples and containment designs.
Generating A Quality Attribute Profile For Antibody-Based Biosimilars: Assessing Differences In Fc-Associated Effector Functions4/13/2021
During biosimilar drug characterization, the use of orthogonal methods is necessary in providing a complete, detailed overview of the molecule being assessed – Surface Plasmon Resonance (SPR) assays allow for the description of an interaction by both kinetics and affinity, and are able to generate a wealth of information per sample assessment. Here, we review the use of the Sensorgram Comparison tool of the Biacore T200 software in two separate case studies, to detail instances where the affinity (KD) measurements and the binding responses did not sufficiently describe the drug substance interaction to the associated ligand.
From Research To Commercial: A Seamless Supply Of Oligonucleotides4/24/2020
This white paper discusses how to meet the seamless supply challenge by providing development, scale-up and synthesis capabilities of research to commercial quantities of customized oligonucleotides.
Viral Clearance: The Basics On How To Conduct Effective Studies5/17/2019
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
End-To-End Thinking During Drug Product Development10/7/2020
In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.
Ensuring Consistency In The Supply Of Cell Culture Media12/16/2020
This paper describes a robust, global manufacturing network for cell culture media that supports capacity expansion to meet growing demand and ensure business continuity.
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