Small interfering RNAs (siRNAs) are short sequences of RNA that interfere with gene expression, reducing or eliminating the expression of a disease-related protein by targeting its corresponding mRNA. siRNAs could treat a wide array of diseases. How does it differ from other therapeutic modalities such as gene therapy and gene editing?
- Your Guide To Producing ADCs That Meet cGMP Expectations
- Data: The Near Future Of Regulatory Info Management In Europe
- Biopharma CMC/Regulatory Relationships In a Global Market
- Heightened Standards For Satisfying Written Description In Pharma Patents
- CAPA System Best Practices For GMP Compliance
- India’s Biopharma Innovators Tackle COVID-19 Vaccine Supply Worldwide
- 3 Strategies For Optimal Oversight Of Your Outsourcing Partner
AAV Gene Therapy Takes On Kidney Disease
Built on the back of Prof. Moin Saleem’s two decades of cellular-level kidney research, Purespring Therapeutics is reimagining the treatment of kidney diseases that affect nearly a billion people worldwide. The company is preparing a first-of-its-kind AAV gene therapy candidate for the clinic.
At ISPE’s 2022 Biotechnology Conference In Boston, CBER Director Dr. Peter Marks kicked off three days of programming with reflections on the COVID-19 pandemic as a catalyst to advanced manufacturing in biologics, sharing his vision for industry and the role of the FDA.
Convergent Therapeutics is bullish on the combination of radioisotopes and antibodies to direct radiation directly to cancer cells. As enabling technologies improve on previous failures, CEO, CMO, and co-founder Dr. Philip Kantoff is projecting a new wave of activity in the space among biopharmas big and small.
Join multifaceted mAb manufacturing experts Gene Lee, CTO at AltruBio and Avril Vermunt, Sr. Director of Manufacturing Sciences & Technology at
EQRx for a discussion on making mAbs more efficiently in the face of rising costs, growing complexity, and constricting cash runways.
Dr. Daniel Teper and his team at Cytovia Therapeutics have developed a unique combination of candidates designed to improve access to safe and affordable "off-the-shelf" cell therapies. Founded just four years ago, the company is preparing multiple clinical trials of IPSC-derived therapies, which Dr. Teper says lend to a consistent, scalable manufacturing process.
Your Guide To Producing ADCs That Meet cGMP Expectations
Antibody-drug conjugates (ADCs) are a diverse class of biopharmaceuticals that combine highly selective monoclonal antibodies specific to surface antigens present on particular tumor cells. Discussion of current good manufacturing practices (cGMP) in this article includes containment, cleaning and decontamination, and manufacturing and purification.
Data: The Near Future Of Regulatory Info Management In Europe
Data, rather than static documents, is the future of regulatory information management. It also paves the way for information to be shared in different formats as use cases dictate, while still ensuring the consistency of the data. Even though regulators haven’t quite got their ducks in a row yet, they know full well that this is the scenario that everything is pointing toward. So, to prepare for anything less would be unwise.
Heightened Standards For Satisfying Written Description In Pharma Patents
In Biogen Intl. v. Mylan, the Federal Circuit invalidated claims in one of Biogen’s patents based on its finding that a claimed dosage limitation was insufficiently described in the disclosure and, thus, failed to meet the written description requirement. Between that case and another recent case, the Federal Circuit is showing heightened scrutiny on this patenting subject.
CAPA System Best Practices For GMP Compliance
A CAPA system should be understood as an important element of the pharmaceutical quality system and implemented uniformly throughout the company or group. This article delves into the pros and cons of autonomous and integrated systems, and shares some overall CAPA best practices.
India’s Biopharma Innovators Tackle COVID-19 Vaccine Supply Worldwide
This article discusses the roles that Indian biopharmas Serum Institute of India; Biological E, Ltd.; Bharat Biotech; Premas Biotech; and Zydus Cadilla have in supplying North America, Africa, and other regions with COVID-19 vaccines.
3 Strategies For Optimal Oversight Of Your Outsourcing Partner
Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.
How Can We Move RNA Forward In Our Therapeutics Arsenal?
RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.
Three Imperatives To Make Regenerative Medicine An Everyday Reality
Three imperatives that will help make regenerative medicine part of everyday medicine explained.
BIOPROCESSING WHITE PAPERS
Viral Vector Vaccine Bioprocessing Handbook
Vectored vaccines show promise in their reliability to induce potent cell-mediated immunity. This paper describes a template to manufacture an adenovirus-based vaccine.
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.
Improve Biopharma Fermentation With Innovation, Collaboration12/28/2020
Organizations developing products requiring fermentation often create custom processes from scratch, leaving room for inefficiencies, lost value, and, in the case of significant error, costly time delays.
Navigating The Regulatory Maze: Fundamentals For Drug Development7/15/2022
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
Upstream Viral Safety: A Holistic Approach To Mitigating Contamination Risks8/17/2020
The safety of biologics from adventitious agents requires a multilayered strategy of controlled manufacturing processes and risk mitigation to prevent contamination.
In Vivo-like Cell Culture: The Impact Of 3-Dimensional Technologies On Your Cell-based Applications12/14/2021
The limitations of 2D cell culture can cause roadblocks to research and contribute to poor predictive power of preclinical cell-based drug and toxicity screening assays. In this article we explore several more reasons why 3D is better and provide tips for perfecting the technique for optimal results.
BIOPROCESS ONLINE CONTENT COLLECTIONS
From setting up and implementing a QRM program to objectively measuring your risk appetite and risk tolerances to proving sound risk management through factory and site acceptance testing (FAT and SAT), this e-book offers a collection of fresh insights from biopharma risk mitigation experts to help guide your risk management strategy.More Content Collections