There is a rise in the demand for large-volume parenterals (LVPs) due to an increase in the number of surgeries and people requiring frequent hospitalizations due to chronic diseases. As opposed to the climbing interest in LVP, pharma companies are unable to cater to this burgeoning demand as very few manufacturers are efficient enough to produce high-grade LVPs. This is where a pharma giant can depend on CDMOs for their manufacturing services. LVPs are highly sensitive products, which only a highly reputed contract pharmaceutical company can manufacture. It is noted that an increase in demand and at times delay in manufacturing or any other issue may result in the shortage of LVP supply. Therefore, a robust system is needed to overcome these challenges. Also, if the contract manufacturing company religiously adheres to cGMP, most of these issues do not occur in the first place.
What is a large volume parenteral?
Parenteral solutions usually come in small and large-volume products. A large volume parenteral (LVP) is an intravenous solution that is sold in a container such as a bag or a bottle. A volume greater than 100 mL comes under the category of LVP. It usually ranges from 100 mL to 5000 mL but can extend to more than this limit. The other type is known as small volume parenteral, which has a volume of less than 100 mL. Some examples of LVPs include Sodium Chloride 0.9%, dextrose, salts, amino acids, albumin, and dextran at different concentrations.
Complications in LVP manufacturing
The major ingredient of an LVP is usually water whereas the active drug ingredient is variable based on the end user’s requirement. Only manufacturers that have a massive production capacity of thousands of liters can prepare LVPs efficiently. All pharmaceutical manufacturers face a set of challenges when it comes to manufacturing sensitive LVPS. For instance, every manufacturing operation has to be followed by Cleaning-in-place (CIP) and Sterilization-in-place (SIP) systems i.e. all the manufacturing vessels and holding vessels have to be free of any contamination and residue.
Issues of bioburden, bacterial endotoxin, and particulate matter are major concerns for pharma manufacturers that significantly impact the quality of the product. Sometimes these issues may even render the whole batch unfit for use, thereby resulting in a waste of time and resources. The timing between washing, drying, and sterilizing steps plays a crucial role in determining the quality of products. If the time taken between these steps is prolonged due to any reason, the chances of contamination by microbes are enhanced.
Akums Drugs & Pharmaceuticals Ltd
Being the largest contract pharmaceutical manufacturer in India, Akums Drugs & Pharmaceuticals Ltd has fifteen state-of-the-art facilities to manufacture all types of dosage forms. The company’s plants are located in Haridwar, Kotdwar, and Baddi. In addition, there is a centralized stability center that has 10 walk-in stability chambers and one photostability chamber. All these facilities together ensure that only the best-in-class large-volume parenterals are manufactured. Akums can produce different types of LVPs such as electrolytes, carbohydrates, contrast agents, blood derivatives like albumin, drug premixes, nutritional solutions like proteins, and lipid emulsions among others. To prevent any chance of contamination compromising the quality of downstream elements of LVP, Akums uses effective pharmaceutical-grade depth filters during the initial stages of processing.
