Industry, regulatory, and academic experts recently gathered at the United States Pharmacopeial Convention’s (USP’s) annual Peptides & Oligonucleotides Workshop virtually to share best practices on chemistry, manufacturing, and controls (CMC) for peptides. This article summarizes discussion highlights.
- Patenting Antibodies: The 4 Tactics To Use In 2021
- What Do Artificial Intelligence And Continuous Validation Have In Common?
- Outlook: Biotech In 2021 & Beyond
- Statistical Methods For Comparing Small-Scale Models To At-Scale Biopharmaceutical Manufacturing
- Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing
- Implementing Small-Scale Models For Biopharmaceutical Development
- Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise
What Do Artificial Intelligence And Continuous Validation Have In Common?
Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.
Outlook: Biotech In 2021 & Beyond
Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.
Statistical Methods For Comparing Small-Scale Models To At-Scale Biopharmaceutical Manufacturing
As the final article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article discusses statistical methods for comparing SSM outputs to at-scale outputs and covers descriptive statistical methods, inferential methods, difference tests, equivalence tests, and more.
Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing
As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup.
Implementing Small-Scale Models For Biopharmaceutical Development
Small-scale models (SSMs) are widely used for process development and optimization, scale-up, technology transfer, process characterization, process validation, and more. This article from a BioPhorum Development Group 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
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.
Are You Ready For The FDA’s “Data Effect” Tsunami? 8 Steps To Prepare
The FDA is moving forward with its Data Modernization Action Plan, the next leg of the Technology Modernization Action Plan. As such, 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.
BIOSIMILAR WHITE PAPERS
The Role Of CDMOs In Cell And Gene Therapy Process Development
This article highlights areas where CDMOs can help companies get started in CGT manufacturing. We also discuss when to engage with CDMOs to maximize commercial and clinical success.
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.
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.
Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up2/11/2020
In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.
Scaling A mAb Production Process To A Single-Use Platform9/27/2019
The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.
Meeting Diverse Biologic Pipeline Process Development Challenges9/10/2020
The biopharma manufacturing industry has been evolving at an unmatched pace. Understanding and managing diverse molecule challenges is key to ensuring they reach patients safely and efficiently.