Friday, August 12, 2022

The Four Stages of Drug Manufacturing

Solid dose cdmo, liquid manufacturing cdmo, CDMO pharmaceutical company

Large-scale production of drugs is a complex procedure that requires specialized equipment and skill. With the growth in the pharmaceutical industry, more companies partner with CDMOs to develop and manufacture drugs.

Outsourcing production by hiring contract partners fills production and expertise gaps. SovPharma has over 30 years of experience as a CDMO pharmaceutical company and has worked with long and short-term contracts and development partners that can deliver high-quality drugs. Our manufacturing expertise and operational know-how accelerate the drug production process and shipping to distributors. 

In this article, we will be describing in detail the four primary steps in the drug manufacturing process. 

Drug Blending

This is the first step in producing any drug, and it's one of the most delicate stages. For drug blending, we mix the already developed formulation with non-active ingredients to develop a stable and consistent mixture. 

In cases where the formulation is yet to be developed, Sovereign Pharmaceuticals can develop a formulation for the client. We have the equipment, expertise, and experience to develop drug formulas and oversee their production. We also partner with a network of contractors we outsource to guarantee the quality of the final product. 

Mixture Stability

The blending process is all about balance and uniformity in everything. The mixture must be stable and consistent without altering or damaging the structure of the drug. To do this, we determine the batch size, select an appropriate blender, calibrate all blending equipment and measure out all the ingredients. 

With all the variables determined, it is time to begin the blending process. 

Drug Coating

Our commercial coating equipment is powerful, versatile, and capable of high volume production. We can meet a wide range of temperatures, widths, speeds, and batch sizes. Plus, we can produce both water and solvent-based products. 

To create the most effective coating process for our clients, we get the best pieces of equipment, hire and train our staff, and rely on experience to maintain the high standard since our inception in 1990. 

These factors combine to create an effective and efficient production process for our clients. 

Comma Head Coating Vs. Slot Die Coating

A comma head coating is favorable for solvent-based systems because they offer an intuitive operation, allowing for better uniformity in coating thickness. The main disadvantage of the comma head is that any variation in the release line or quality of the release coating impacts how it is shared. 

Slot die coating involves a completely closed system, eliminating the possibility of solvent loss or contamination. The main disadvantage of the slot die is that it makes dialing in the process for precision too difficult. 

Serialization

Serialization is a big part of drug production. Pharmaceutical companies need a way to track and label drug batches. Our serialization capabilities can meet the highest commercial quantities. 

We follow HDA guidelines and GSI standards for proper labeling and EPCIS formatting. We fully believe in our ability to produce fully traceable drug batches. We oversee every stage in drug production and assign serial tracking numbers on a product in a reliable and repeatable manner. 

Shipping

After a successful production of a product, we oversee the shipping to distributors and consumers. As part of our CDMO services, we develop a shipping process to match the client's exact needs. 

Our primary goal is to see that every client receives their shipment on time and in excellent condition. 

Are you interested in partnering with Sovereign Pharmaceuticals for your solid dose cdmo or liquid manufacturing cdmo needs? Contact us today.


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