Learn About a CDMO Pharmaceutical Company

CDMO stands for Contract Development and Manufacturing Organization, a term used to describe companies that provide drug development and manufacturing services. Pharmaceutical companies partner with CDMOs as a way of getting external support during drug development and manufacturing.

Sovereign Pharmaceuticals provides the most comprehensive all-in-one CDMO for pharmaceutical companies. As a full-time CDMO pharmaceutical company, they can take on every aspect of drug development and manufacturing. We also have other subcontractors we work with for top-quality service. It all depends on what our clients need.

Some of the services CDMOs offer include:

• Blending
• Table coating
• Roller compaction
• Milling and sizing
• Oven tray drying
• Wet granulation
  
  

What is The Difference Between CDMO and CMO

CMOS are companies that take pre-formulated drugs and manufacture them, while a CDMO can take care of the entire process, including development. Many pharmaceutical companies enjoy using CDMOs because of their consistency and timeliness of production. Realistically, partnering with a CDMO seems more advantageous, and it comes with fewer opportunities for miscommunication.

 

Advantages of Partnering With a CDMO?

Developing a new drug or variant takes years and consumes millions of dollars. Many times, it is too big an undertaking for pharmaceutical companies, so they partner with CDMOs for the development and manufacturing of drugs.

Some of the key advantages of contracting a CDMO include:

Our Expertise

It will surprise you the vast amount of resources and experience available in CDMOs. For over 30 years, we've learned and continue to invest in talented chemists, researchers, and development professionals who contribute to the development and manufacturing of drugs.

Equipment and Facilities

Not all pharmaceutical companies can afford to buy every piece of equipment they need to produce drugs. CDMOs, on the other hand, invest heavily in getting the best equipment and facilities. This makes us more equipped to handle drug development and manufacturing.

One common problem with in-house drug development and manufacturing is what happens when something needs to change. Can the company introduce a new variant or increase production? CDMOS can produce as many as 1,000,000 tablets.

Outsourcing to CDMOs gives companies access to better-specialized pieces of equipment and facilities without the expense of owning them.

 
Scalability

CDMOs are vast manufacturing and production companies. Their size makes them more accommodating to changes in the demands of pharmaceutical companies. When there is a shift in product demand or the introduction of a new variant, Pharma companies don't like to venture because it can be very risky.

But with the security of a CDMO partnership, making these decisions exposes the company to fewer risks, and manufacturing gets completed on time.

 

Conclusion

Outsourcing pharmaceuticals is quickly becoming the fastest and most effective way for pharmaceutical companies to develop and manufacture drugs. With over 30 years of experience and facilities, SovPharm is the leader for your solid dose cdmo and liquid manufacturing cdmo needs. Click here to explore our website.

An Introduction To a CDMO Pharmaceutical Company

If this is your first time hearing the term CDMO, it means Contract development and management Organization.The Pharma industry was valued at $405.52 billion in 2020 and continues to grow. Not every company that makes up the industry can afford to develop and manufacture drugs. CDMOs came as the solution to such problems.

What is Pharmaceutical Contract Manufacturing?

Pharmaceutical contract manufacturing is the process in which pharmaceutical drugs are developed and manufactured on a contract basis. Drug companies hire CDMOs to make their drugs for them. A CDMO can take part in the development and manufacturing process, which streamlines the production and leaves room for no finger-pointing if something goes wrong.

Why Partner With A Manufacturing Company?

Developing and manufacturing drugs is a very risky undertaking that can cost millions of dollars. Pharmaceutical drugs also have complex formulas and need specialized equipment and conditions to mass produce.

Pharmaceutical companies no longer have to go through this complex and time-consuming process. CDMOs provide a flexible and streamlined approach for pharmaceutical companies to manufacture quality drugs and provide them in large quantities enough to supply the market. We are an easier and faster way to produce quality drugs.

What Does The Pharma Manufacturing Process Look Like

Every drug has something that makes it unique, an ingredient in the complex puzzle stored in the formulas. To manufacture any drug safely, the manufacturer must follow specific manufacturing procedures.

To achieve a successful result, the manufacturing process can be categorized into four different steps.

Step 1 Blending

Blending is the first step in the drug manufacturing process. At this stage, the active pharmaceutical formula is mixed with non-active ingredients until there is a uniform mix. If the formula fails to achieve consistency in dozes, the drug won't get approved.

This is a very delicate stage in the manufacturing process. Every variable must be perfect. CDMOs have the skills to pull off precise measurements of ingredients, viscosity, temperature, and time to repeat the optimum state of uniformity in drug production.

Step 2 Coating

There are varying reasons why coatings are added to drugs. The most common reason is to improve taste, add color or make the drug easier to handle without compromising the makeup of the drug.

Step 3 Serialization

Before a drug is packaged and ready for distribution, each sealable unit undergoes serialization. This is a process of assigning a unique serial number to the finished product. This number is affiliated with the drug's origin, bar code, batch number, and expiration date.

Step 4 Shipment

The final stage of production is getting the drug delivered to the consumer. Pharmaceutical shipping requires specialized procedures, packaging, and serialization, so no mistakes are made, whether it's a single cartoon or giant pallets; CDMOs guarantee that the correct batches of drugs are shipped on time and in perfect condition.

SovPharm is a CDMO pharmaceutical company. We're your one-stop shop for all things CDMO, covering formulation development, clinical trials, QA, regulatory, solid dose manufacturing, liquid manufacturing, and everything in between. 

What Are The Stages of Drug Development?

For any drug to get FDA approval, it must pass through several stages of development and manufacturing to ensure the product is safe, efficacious, and has passed regulatory requirements. 

SovPharm is the only CDMO pharmaceutical company that you need. We aid you through the stages of developing a drug. Our staff and facilities can help you determine what tests you need to conduct and perform all the necessary tests and studies needed to get FDA approval. 

We thought it would be a great idea to show our clients an in-depth overview of the stages in drug development and the necessary studies we conduct. Keep in mind that this is only a guide, and it has been simplified significantly. If you have any specific questions, contact Sovereign Pharmaceuticals at () to speak to a knowledgeable resource. 

Stages In Drug Development

Discovery

Discovery begins with choosing a biochemical mechanism involved in a disease condition. Scientists identify candidates from academic and pharmaceutical/biotech research labs and are tested for their interaction with the drug target. 

Every one of the 5,000 to 10,000 molecules for each drug goes through a rigorous screening process which can include genomics, proteomics, and other screening methods. Once scientists confirm interaction with the drug target, it is time to choose one or more lead compounds for the drug. 

Product Characterization

When the molecule has therapeutic traits, it must be characterized. Its molecule size, shape, strength, weaknesses, preferred storage conditions, toxicity, bioavailability, and bioactive must be carefully defined. 

Early-stage pharmacology studies help characterize most of the foundational mechanisms of action of the formula. 

Formulation, Delivery, Packaging, Development

CDMOs must develop a unique formula that ensures proper drug delivery parameters. Drug formulation and delivery may be modified continuously as the drug passes through different stages in development, even after final approval. 

We also perform extractable and leachable studies on containers and packaging to guarantee the drug's stability. Our scientists look at all the parameters involved with storage and shipment, such as light, temperature, time, humidity, etc. it is important that we find a way to transport the final product to distributors, so they arrive potent and sterile. 

For all your solid dose cdmo and liquid manufacturing cdmo needs, contact us today.

The Four Stages of Drug Manufacturing

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.