Featured Bioprocessing Editorial
Draft FDA Labeling Guidance Proposes More Clarity For Providers
The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space. This article breaks down and analyzes the update on labeling for prescription drugs and biologics on an increasingly complex landscape.
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
Financing For Emerging Biotechs: Recent Trends & Predictions For 2023
After a stellar 2020 and 2021, overall early-stage financing for small and midsize biotechs declined significantly in 2022 due to a range of factors. Ernst & Young provides insights into those factors and trends, as well as the key focus areas for biotechs in 2023.
4 Lessons Learned Developing Cancer Immunotherapy Treatments
The ability to build up cancer-attacking T cells in cancer patients remains a major limitation of current immunotherapy approaches. PDS Biotech's CEO and CSO share four lessons they have learned along the way in developing their lead product, PDS0101, an immunotherapy targeting HPV-positive cancers.
Platforming Strategies To Increase Throughput With Better Standardization
Biologics development and manufacturing platforms should fit their target product profile. Here are four considerations for building more efficient platforms.
Embracing Robotics To Scale Cell And Gene Therapy Manufacturing
This article explains the robotics landscape, the difference between automation and robotics, as well as three steps to introduce robotics into your cell and gene therapy business.
Global Market Outlook On Stem Cell Manufacturing
The stem cell manufacturing market is rapidly growing and is expected to grow from $11.22 billion in 2022 to approximately $23.89 billion by 2030. What are the key market drivers, restraints and challenges, and advancements to watch?
ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.
Strategic Procurement For Emerging Pharmas & Biotechs
Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.
Biotech’s Market Outlook In 2023 & Beyond
This article discusses three key themes in 2023 that are likely to have an outsized impact on biotech companies as well as the notable longer-term trends to watch over the next few years.