During my career as an executive in pharmaceutical manufacturing quality assurance, I have heard the term “cost of quality” (COQ) over and over when advocating for budget and resources. Most people think that it is just an excuse for higher costs, but that is not true. I'll share what is involved in calculating the COQ and why it's important.
- 5 Hot-Button Issues In Parenteral Packaging
- The Global Market For Generic Sterile Injectables To Double In Value By 2032
- All You Need To Know About Contamination Control Strategies, Part 1
- A Digital-First Approach To Bio/Pharma Manufacturing Operations
- FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs
- India’s CROs & CDMOs Come Of Age In The Global Marketplace
- Improving Digital Integration Between Biomanufacturers & Partners
5 Hot-Button Issues In Parenteral Packaging
Five key issues related to parenteral drug packaging came to the forefront of the PDA Parenteral Packaging Conference held in Venice, Italy, in April.
The Global Market For Generic Sterile Injectables To Double In Value By 2032
According to new analysis at insightSLICE, the global generic sterile injectable market size was estimated to be $79.95 billion in 2022 and is expected to grow to reach $159 billion by 2032. What are the key factors and trends driving this growth? This author shares the key data-led insights.
All You Need To Know About Contamination Control Strategies, Part 1
In the first of this two-part series, microbiology and contamination control specialists Vanessa Figueroa, Rebecca Brewer, and Greg Gibb, Ph.D., discuss best practices in developing contamination control strategies through the lens of the newly formalized provisions in the EU GMP Annex I, Manufacture of Sterile Medicinal Products.
A Digital-First Approach To Bio/Pharma Manufacturing Operations
Features such as real-time data monitoring, cloud solutions, and process integration comprise a digital operational excellence approach that adds value. But successful deployment of these and other digital solutions requires careful, cross-functional collaboration across the full life cycle of the project.
FDA Issues New Guidance On Discontinuance Or Interruption In Manufacturing Of Finished Products Or APIs
In April 2023, the FDA issued an updated guidance superseding and replacing the previous 2020 document about managing drug shortages and explaining what was expected of industry and how the agency was going to manage the shortfalls. This article summarizes the guidance in a helpful FAQ format.
India’s CROs & CDMOs Come Of Age In The Global Marketplace
Most of the top 10 pharmaceutical companies and many large biotech companies today get a portion of their preclinical/clinical research, drug development, and/or manufacturing done in India. While a low price is the initial attraction, there are additional factors that can be more meaningful.
Improving Digital Integration Between Biomanufacturers & Partners
Sponsors are working with more contract organizations, and contract organizations are working with more sponsors. There is often a mismatch in digital maturity (IT capabilities) between the two sides of a partnership. We must work toward a bidirectional sharing of data and process knowledge. This road map from BioPhorum will help.
BIOSIMILAR WHITE PAPERS
Orthogonal Methods To Understand And Define CQAs Of AAV Therapies
An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
Outstanding Sensitivity For Confident SPR Interaction Analysis7/20/2022
Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.
Containment Solutions To Help Emerging Biologic Companies Get Products To The Market Faster3/24/2023
Gain solutions on how to set up your small company for long-term success using packaging containment offerings and services to help mitigate risks and speed up your time to market.
Optimizing Lipid Formulations For Targeted RNA-LNP Applications9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
Regulatory Considerations For Alternative Microbial Methods2/28/2022
This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.
Taking Charge Of Your Stability Program10/5/2022
Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
BIOSIMILAR APP NOTES & CASE STUDIES
- The Biosimilar Leadership Playbook: 5 Tips For Success
- Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?
- The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 2021
- The Top 5 Biosimilar Developments Of 2020
- Will These Big Biosimilar Questions Be Answered In 2021?
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.More Content Collections
BIOSIMILAR DEVELOPMENT NEWS
- US FDA approves the Cyltezo® Pen, A New Autoinjector Option, Ahead Of July 1 Commercial Launch
- Sandoz Marketing Authorization Applications For Proposed Biosimilar Denosumab Accepted By EMA
- Celltrion USA Announces U.S. FDA Approval Of Yuflyma (adalimumab-aaty), A High-Concentration And Citrate-Free Formulation Of Humira (Adalimumab) Biosimilar
- Alvotech And Advanz Pharma Extend Strategic Partnership To Commercialize Five Proposed Biosimilars In Europe
- Cytiva And Pall Life Sciences Complete Integration To Create A Global Innovation And Solutions Leader In Biotechnology
- Alvotech Reports Financial Results For First Three Months Of 2023 And Provides Business Update
- Teva Launches New ‘Pivot to Growth’ Strategy
- Amneal Launches Third Biosimilar With FYLNETRA (pegfilgrastim-pbbk) In The United States
- 05.25.23 -- The Global Market For Biosimilars Through 2032
- 05.18.23 -- Final FDA Guidance Defines Suspect & Illegitimate Drug Product
- 05.15.23 -- Futureproof The Design Of Your Biomanufacturing Capacity
- 05.11.23 -- How Can Life Sciences Navigate M&A In 2023
- 05.09.23 -- Controlling Raw Material Variability