Harry Selker, M.D. sits down with BioProcess Online for a candid discussion on the Clinical Research Forum’s work, its recognition of advances in clinical and translational research, and why that’s such an important structural element in the bridge between academia and industry.
- How Computational Biology Birthed A Biopharma
- How to Ensure Your Quality Culture Assures Data Integrity
- Tools And Best Practices For Trending Environmental Monitoring Data
- Your Drug Development Team Holds The Key To The Clinic
- Biopharma Cold Chain Logistics 101
- Why Adjusted Risk Likelihood Should Displace The Risk Priority Number
- An Introduction To Trending In Environmental Monitoring Programs
Your Drug Development Team Holds The Key To The Clinic
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.
The FDA has tightened timelines and is, in fact, approving more therapies at a faster pace than in recent memory, but it’s not all COVID, all the time. Allan Shaw helps us expose regulatory approval trends, and the implications of those trends on the biotech business.
NeuBase Therapeutics CEO Dr. Dietrich Stephan discusses the important role computational drug discovery plays as we emerge from what he characterizes as “a decades-long, multi-billion-dollar chemical engineering escapade with a very low success rate to find one drug.”
Biopharma Cold Chain Logistics 101
Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.
Why Adjusted Risk Likelihood Should Displace The Risk Priority Number
While the RPN primarily represents a risk event’s severity, perhaps a more important attribute to focus on is the risk event’s likelihood of occurrence. In this provocative article, Mark Witcher, Ph.D., proposes an adjusted risk likelihood rating approach that emphasizes a risk event’s likelihood of occurrence.
An Introduction To Trending In Environmental Monitoring Programs
Trending environmental monitoring (EM) data is a regulatory requirement. However, it is useful in obtaining significant information about the facility. Trends can help determine if your facility is in a state of microbial control and relay the data to facility management in a meaningful format. In this two-part series, Crystal Booth of PSC Biotech looks first at the regulations and guidelines around EM.
FDA Inspections: Are Changes On The Horizon?
A year into the pandemic, the FDA is still conducting only limited inspections in the U.S. and evidence has emerged of a significant inspection backlog that could compromise the safety and quality of the U.S. drug supply. Kalah Auchincloss of Greenleaf Health provides a brief timeline of inspection-related events over the last year, discusses the impact, and examines the changes that we might expect as the FDA begins to shift back to normal operations.
Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across
Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.
Life Sciences Dealmaking Aims At Early Stages Amid COVID-19
Life sciences companies remain unabated when it comes to creatively making deals during the COVID-19 pandemic, particularly among those targeting biopharma companies with early-stage assets.This article highlights takeaways from the KPMG 2021 Healthcare & Life Sciences Investment Outlook, which tallied 1,138 acquisitions, licensing, and R&D deals in 2020.
Complying With Batch Release: Auditing Electronic Batch Records
This article presents some advice for auditing electronic batch records to assess their current good manufacturing practice (cGMP) status. This is useful in the qualification stage and essential once the electronic record system is in operation.
Assessing CT-P13 SC’s Impact Across Indications
This is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.
BIOPROCESSING WHITE PAPERS
Recombinant Collagen Via Fermentation: Safety, Sustainability, Acceptability
The production of recombinant collagen made via fermentation-based processes addresses the market need for collagen that is safe, sustainable, reproducible, and acceptable to consumers.
The Integrated Pharmaceutical Development Platform: Transform The Commercialization Of Innovative Therapeutics7/21/2020
This whitepaper introduces the concept of the electronic Development Record (eDR) and how a holistic, platform approach to the capture, management and re-use of product and process data can propel the development process forwards, reduce costs, improve quality and enhance corporate image.
Challenges And Practical Solutions For Switching To Prefilled Syringes For Injectables9/1/2020
To achieve the benefits of moving a final product presentation from vials to prefilled syringes, it is important to understand the challenges during this solution as well as practical solutions.
Adding Versatility With Single-Pass TFF10/18/2019
In the early days of the biopharmaceutical industry facilities used inflexible, hard-piped equipment and stainless steel bioreactors and tanks. More recently, single-use technologies have emerged, presenting an attractive alternative that allows companies to eliminate cleaning validation requirements, while reducing the risk of cross contamination. Single-pass TFF is a convenient means of reducing volumes, column sizes and hardware costs, as well as eliminating tank bottlenecks – and can be powerfully combined with single-use technology.
Business Continuity Program: Maintain Operations During Crises5/5/2020
Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.
Producing Publication-Quality Data With Automated Western Blots3/16/2021
How Simple Western overcomes the challenges and pitfalls associated with traditional Western blots to produce publication-ready data that meets the highest standards of data integrity and rigor.
BIOPROCESS ONLINE CONTENT COLLECTIONS
As the initiative to combat the global pandemic continues to play out and consume supply chain resources, the fast-approaching requirements of the Drug Supply Chain Security Act (DSCSA) remain. To help biopharma supply chain pros juggle these equally high priorities, we've assembled a collection of columns on these supply chain considerations, authored by independent experts on the topics at hand. We trust you'll find their guidance valuable.More Content Collections