Drug development requires an average overall investment of USD 1.5 – 4.5 billion and remains at high risk due to the huge attrition rate phase after phase [1; 2]. The pre-clinical development phase and the phase 1 clinical trial show the highest attrition rate due to toxicity or drug metabolism...
In pharma, quality is a high-stakes business — not only measured in dollars, but more importantly, impacting patient lives. This eBook will discuss what it takes to achieve consistent quality in a changing manufacturing landscape.
Gain insight on:
- How new AI applications can automate the...
In formulation development, the scale-up from a lab-bench production of small batches to a large-scale production due to a demand for bigger batches, e.g. for clinical trials or economic reasons, can often be challenging. Thus, the possibility to scale-up the manufacturing process is imperative...
When a label on a bottle says “100 tablets”, we assume there are 100 tablets inside, don’t we? Not 99 or 101, but exactly 100. To be more precise, it is expected that the bottle contains exactly 100 undamaged tablets of the same kind. Obviously, bottle filling technology must meet two bigger...
With tightening regulations and rising costs, the pharmaceutical industry is being presented with a consistent challenge in the marketplace: Do more with less. As a result, pharma companies are reducing their internal capacities in manufacturing and R&D and are, instead, increasing their...
In the biotechnology and pharmaceutical industries, hygiene, consistent performance and flexibility are
decisive factors for efficient, as well as safe production with a high degree of automation. VEGA offers worldclass measurement technology for level and pressure. We are specialists in this area.
Water hammer can be so damaging to machinery and dangerous to human health that every effort should be taken to prevent the hazard. Also known as hydraulic shock, water hammer sounds like a mechanical noise and is sometimes perceived to be a valve slamming closed. In reality, it is a phenomenon...
Two commonly used drugs in urology, Mitomycin and Gemcitabine, are included on the NIOSH list. As hazardous medications, USP 800 requires significant investment to safely compound and administer doses of these drugs. Edge Pharma developed a solution that solves this issue for hospitals, surgery...
A customer contacted Freund-Vector asking for a requirement to coat tablets on a LDCS-Pro Hi Coater (150L batches) and needed contained loading, sampling and unloading of their tablets.
Lack of data integrity is the main reason for most FDA warning letters.
For laboratories that must comply with GLP, GMP and GAMP regulations it is important to have records or documented evidence of all relevant analyses that can be checked by a second person and are also readily available...
The latest approaches for characterizing non-crystalline (amorphous) materials and determining physical stability under typical storage conditions. Amorphous forms consist of disordered arrangements of molecules that do not possess a distinguishable crystal lattice. Different forms of a drug...
We suggest that containers which are not produced to a recognized standard of cleanliness are a potential source of contamination.’ This article discusses why this is a problem for biopharmaceutical and vaccine manufacturers, the nature and source of possible contaminants, and a readily...
To make the products safe for water distribution there must be protective
barrier material, joining, and sealing materials. These materials will ensure
that the water remains free from any contaminates that may be present on
or in the metal, paint, gaskets, lubricants, etc.
NSF/ANSI has...
For many companies, especially those that have existing clean room implementations, the opportunity cost and associated risks to integrate an aseptic isolation system were simply too high. But — if we can go out on a limb to say it — the time has come to kill off the clean room.
A dry-powder inhaler (DPI) is a device that delivers medication such as corticosteroids to the lungs through inhalation. DPIs are commonly used to treat respiratory diseases such as asthma and chronic obstructive pulmonary disease. The powdered substances used for this purpose need to have a...
Formulation and process development for injectable products are typically conducted at laboratory-scale. There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. The...
A clinical packaging strategy that can successfully manage the supply of your expensive drug product throughout the duration of clinical testing is critical to the success of sponsor companies.
This paper explores six strategies that can be used to maximize a short drug supply for your...
This white paper explains the theory behind the MCA algorithm
methodology. Then, used in tandem with in-situ fiber optics, the accuracy of the technique is demonstrated by recovering the concentration of two APIs in known mixed solutions. Finally, an example is given of accurately monitoring...
Expectations include:
• Understanding products and processes in order to implement Quality by Design (QbD) into product development
• Delivery of quality metrics for risk-based inspection schedules as proposed by a new quality metrics program
• Shared responsibility for products manufactured...
As the Drug Quality and Security Act’s (DQSA’s) Novem- ber 2017 deadline approaches for serializing saleable units of prescription pharmaceuticals, many pharmaceu- tical companies, particularly small to mid-size organiza- tions, are just embarking on the serialization journey.
There are four...
The electronic, high-tech, semiconductor, pharmaceutical, aero space, medical and many other industries depend on cleanroom technology. As products such as cell phone circuit boards become smaller, the chance of contamination in manufacturing becomes higher. For pharmaceutical companies, clean,...