FEATURED EDITORIAL
As the sector grows, technology and techniques are becoming more sophisticated, including single-use systems, automation, and bioreactors.
- Improving Governance And Compliance With Knowledge Management
- China’s Rising Role On The Global Stage In The Oncology Market
- Nothing To See Here! Just Big Pharma Investments In China
- GMP Plant Uniform Lockers And Procedures: Best Practices
- A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
- Developing A Process Performance Qualification Master Plan For Gene Therapies
- CDMOs Pelted By Slings And Arrows
GUEST COLUMNISTS
-
Improving Governance And Compliance With Knowledge Management
Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.
-
China’s Rising Role On The Global Stage In The Oncology Market
The oncology pharma market has largely been dominated by European and U.S. companies. With the ongoing expansion of the Chinese biopharma sector, innovative oncology drugs will emerge from China and compete on the international market.
-
GMP Plant Uniform Lockers And Procedures: Best Practices
As the use of GMP plant uniforms has gained acceptance, locker room layouts have arisen across companies and sites. This article examines alternatives and optimized approaches.
-
A Deeper Look At What's Driving Dependence On Biotech Contract Manufacturers
Are you struggling to find CDMO capacity? Here are some of the drivers behind the contract manufacturing market's exponential growth.
-
Developing A Process Performance Qualification Master Plan For Gene Therapies
This article provides considerations and a framework for a Process Performance Qualification Master Plan in the gene therapy industry. It is useful for sponsors with any level of experience.
-
The EU’s Ban On TiO2 In Food May Impact Pharma. Here’s What You Should Know.
Titanium dioxide (TiO2) is used as a food additive and OSD pharmaceutical excipient. In 2020, the European Food Safety Authority noted data gaps regarding particle size, which can affect its toxicological properties, so the European Commission banned it as a food additive. Here's how this could impact pharma.
-
What Time Is Best To Bring My CDMO On Board?
The answer might be sooner than you think and entail more transparency than you're used to.
-
Cell & Gene Therapies: An Overview Of FDA Regulatory Considerations For 2024
This article outlines key FDA regulatory developments from the past few months relevant to sponsors seeking approval of cell and gene therapies in the U.S.
PHARMA OUTSOURCING WHITE PAPERS
-
Extended Head Flats Increase Dwell Time
Explore the extended head flat and how this punch modification can improve the compression of difficult formulations.
-
Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing
Lonza’s SimpliFiH®️ Solutions offering is designed to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability.
-
β-Glucan As A Process-Related Impurity In Biopharmaceuticals
In this white paper, we dig deeper into the sources of β-glucan, its influence on manufacturing and patient safety, and ways to detect and control its amounts in the finished drug product.
-
The Business Case For Pharmaceutical Continuous Manufacturing
Examine a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
-
Calculating Your Business Case For Continuous Manufacturing
Review key considerations as a Pharmatech Associates expert introduces a useful financial equation to calculate amortization to develop the business case for PCM and provides a few real-world cases.
-
The Latest Trends In The Prevention And Treatment Of Cervical Cancer
Unearth what immune checkpoint inhibitors are showing promise in treating cervical cancer and how advancements in these treatments paired with additional prevention strategies are improving patient outcomes.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
- A Taste Masked And Easily Swallowed Malaria Drug For Elderly Patients
- Maximize Product Recovery In Bulk Filtration And Filling Flow Paths
- Sterilizing Grade Filter Performance With Biologic Drugs
- Characterization Of Host Cell Proteins By Liquid Chromatography - Mass Spectrometry
- Establishing A Robust Workflow To Identify High-Performing Clones
NEWSLETTER ARCHIVE
CONTENT COLLECTIONS
They say biotech taught pharma how to outsource. So what’s someone who has spent 31 years working in Big Pharma know about outsourcing from the vantage point of smaller organizations? A lot, it turns out. In this latest e-book, Chief Editor, Louis Garguilo sits down with Francis Dumont just after he retired from Pfizer for an in-depth conversation on drug development and manufacturing outsourcing.
More Content CollectionsPRODUCTS & SERVICES
ON-DEMAND WEBINARS
- Risk Control | Bulk Filling Application
- The Synergistic Role Of Drug Safety In Clinical Trial Operations
- De-Risking The Aseptic Drug-Filling Process And Optimizing Production
- Outsourcing High Potent Oral Solid Dose Late-Stage Development: CDMO Insights
- Process Development Optimization For GMP CAR-T Manufacturing