There are 100,000+ venomous animal species, each producing a chemical cocktail of up to 1,000 different components, including peptides, proteins, and non-peptide small molecules. Many in drug development view venom-derived compounds as simple peptides that will be easily digested, limiting their therapeutic potential. This article dispels that myth.
- Your 3-Step Process For Innovation In Precision Medicine
- Venture Philanthropy For Duchenne Muscular Dystrophy
- 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
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 3-Step Process For Innovation In Precision Medicine
Scientific advances are exciting, but not every discovery translates well into the clinic. Why is that? And how can companies successfully position themselves for market success with their drug discovery efforts?
Venture Philanthropy For Duchenne Muscular Dystrophy
This article reviews a number of these advancements and how diseased-focused venture investing can help drive development of next generation therapies.
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.
BIOPROCESSING WHITE PAPERS
Meeting Diverse Biologic Pipeline Development Challenges
The biopharma manufacturing industry has been evolving at an unmatched pace. Understanding and managing diverse molecule challenges is key to reaching patients safely and efficiently.
A Guide To Accelerating Cell Line Development For Commercial Production8/11/2021
Explore the challenges associated with cell line development in the production of biologics, and solutions that can help biotech developers evade the pitfalls of misinformed decision-making.
Navigate The CMC Regulatory Landscape For Cell And Gene Therapies10/9/2020
The curing potential of cell and gene therapies is driving the industry to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.
Factoring The "What Ifs" Into Supply Forecasting8/24/2020
Review considerations for developing a supply plan, the influence of early decisions and their impact on outcomes as a trial progresses, and how decisions can put patients and the trial at risk.
Liquid, Dry Powdered Media, And Advanced Granular Technologies11/3/2021
It's important to assess the cel culture media format that is most suitable for the current and future needs of your process by considering scalability, cost-effectiveness, and convenience.
Taking Biotherapeutic Candidates From Late Discovery To The Clinic1/26/2021
Many initially promising biotherapeutic candidates fail due to lack of efficacy or safety, but there are candidates that fail due to stability, aggregation, and other issues related to cell line or process issues.
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