Using continuous manufacturing technologies is a risk and often a barrier to implementing it. In this first article of a two-part series, the author provides a step-by-step approach outlining the business cases that support adopting continuous manufacturing, with specific considerations for innovators, generics manufacturers, CDMOs, and OTC suppliers.
- Let’s Explore Packaging For Aseptic Manufacturing
- Optimizing Digitalization To Accelerate Your R&D
- Not All Plate Counting Technologies Are The Same
- Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases
- FDA’s Digital Health Technologies Framework Addresses Important Challenges
- A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
- 5 Hot-Button Issues In Parenteral Packaging
Let’s Explore Packaging For Aseptic Manufacturing
When terminal sterilization is not an option, primary packaging materials have a fundamental role in preventing contamination. This article describes how packaging, including containers and closure systems, helps maintain sterility in aseptic manufacturing.
Optimizing Digitalization To Accelerate Your R&D
Drug/therapy development has made significant leaps in innovation in recent years, but common issues that hinder progress still exist. Are you harnessing and optimizing your data for speedier drug development and quicker launch timescales? This article shares important recommendations.
Not All Plate Counting Technologies Are The Same
While rapid microbiological methods have advanced, most microbiology lab tests remain reliant upon assessing microbial growth on agar plates. Discrepancies with plate counting, together with the limitations of human vision, have led to regulatory concerns. This article shares the advantages of automated colony counters. Keep in mind that not all automated plate counters are the same, though — you'll want to look for important functionality.
Leveraging AI In Drug Discovery To Treat MS & Other Autoimmune Diseases
The advancement of artificial intelligence and machine learning algorithms means we can use large pools of genetic data to identify potential risk factors and disease-causing genes for multiple sclerosis and other autoimmune diseases. This author shares a three-pronged approach to analyzing data for AI algorithms, pitfalls to avoid, and AI for silico modeling.
FDA’s Digital Health Technologies Framework Addresses Important Challenges
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms
The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.
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.
PHARMA ONLINE WHITE PAPERS
Nanosuspension Dosage Forms: Product Development & Scale Up
For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.
Overcome Lyophilization Challenges During Development, Scale‑Up And Manufacturing Of Biologic Products1/12/2022
Overcome the challenges associated with lyophilization of biologic drug products by streamlining the scale-up of lyophilization from early development to full commercialization with the use of scalable technologies.
Streamlining Upstream Plasmid DNA Manufacturing12/9/2021
Here we will discuss the scalable process workflow solutions available from initial R&D investment to clinical testing and commercialization.
Balancing Cost Efficiencies In The Drug Development Process1/24/2022
Cost efficiencies and expertise again go hand in hand, with companies often outsourcing or partnering primarily to gain access to manufacturing know-how.
Why More Drugs Than Ever Are Approved Through 505(b)(2)6/6/2022
Discover how bringing a modified version of an existing drug to market through 505(b)(2) can offer a clear path to approval, a differentiated product, and at least some period of marketing exclusivity.
Pharma Manufacturing: Top 10 Pitfalls To Avoid6/1/2023
Pharmaceutical manufacturers face constant challenges and pitfalls common to the industry, but how can you avoid and overcome them to mitigate risk across the board?
PHARMA ONLINE APP NOTES & CASE STUDIES
- The Many Benefits Of Outsourcing Stability
- Achieving Container Closure Integrity During Cryogenic Storage Conditions Using An Optimized Vial Stopper Combination
- Sartobind® Rapid A: High Binding Capacity At Short Residence Times
- Improvements In Recovery, Reproducibility, And Matrix Effects With A Novel Solid Phase Extraction Sorbent
- BEH C18 Batch-To-Batch Robustness For The Analysis Of Rosuvastatin And Impurities
- 06.02.23 -- Discover Pharmaceutical Packaging Service Providers And Suppliers
- 06.02.23 -- Accelerate Your R&D With Digital Optimization
- 06.01.23 -- Pharma Process Equipment Suppliers Ready To Help
- 06.01.23 -- Not All Plate Counting Technologies Are The Same
- 05.31.23 -- Solutions For Pharmaceutical Product Inspection
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
What is Annex 1 and why is it important? What are the major changes? This e-book from Pharmaceutical Online, focuses on that the varying guidelines that will affect sterile pharmaceutical manufacturing operations.More Content Collections