53Biologics

Biologics CDMO: Why You Need One

The rapid growth of the biologics market has made biologics contract development and manufacturing organizations even more crucial.  

The complexities involved in developing biologics and scaling manufacturing to get them on the market makes unfeasible to do the process in-house for biopharmaceutical and pharmaceutical companies. 

What Is a Biologics CDMO Company? 

A biologics contract development and manufacturing organization (CDMO) provides biological medical product development and manufacturing services for pharmaceutical companies. They can be specialized in the development and manufacturing of biologics alone, or they can offer these same services for biologics as well as small molecule drugs. 

When a pharmaceutical company has discovered a new biological medical product, they may choose to partner with a biologics CDMO to outsource one or more steps in the development and manufacturing process.  

Some biologics CDMOs focus on providing support for certain parts in the development process, while full-service biologics CDMO companies have the ability to handle any and all steps of drug development and manufacturing. 

53Biologics offers a manufacturing structure fully customizable and adaptable to fulfill all your need in time, cost and manner

The services that a biologics CDMOs offer are: 

  • Formulation
  • Research and development
  • Manufacturing

Biologics CDMOs offer their extensive experience from pre-formulation to clinical trials and commercial production. That is why outsourcing a CDMO is the best option. 

Now, you may ask the following question: 

What do I really need a Biologics CDMOs, CMOs or CROs? 

The answer depends on your strategy needs. 

CDMOs, CMOs and CROs sound very similar but they are different between each other. 

  • A biologics CMO or Contract Manufacturing Organization is specialized in biological medical products. These companies deal only with drugs that are pre-formulated so they only manufacture drugs and have no involvement in the development. The services that they often offer are: the manufacturing of solutions, emulsions, and nano-suspensions; liquid-filled capsules, aseptic filling, terminal sterilization, pre-filled syringes and vials, and tablets and capsules. 
  • A biologics CRO or Contract Research Organization is specialized only in handling the clinical trial process for biological medical products. They plan, coordinate, and carry out clinical trials, including site selection, recruitment, monitoring, and collecting data. 
  • A biologics CDMO or Contract Development and Manufacturing Organization works in the development and manufacturing and there are also some CDMOs that can offer clinical trial services.  

Because the speed to market is concerns for pharmaceutical companies, the outsourcing of a biologics CDMO for the development, manufacturing, and research process is often the best solution. 

 The biologics market was valued at $9.93 billion in 2020 and is expected to reach $18.90 billion by 2026, with a compound annual growth rate of 11.2 percent between 2021 and 2026. 

Benefits of Working with a Biologics CDMO 

The development of a new biologic is a lengthy and costly undertaking. That is why, to partner with a specialized CDMO for biological formulation development and manufacturing, pharmaceutical companies benefit in the following ways: 

Great Expertise 

A biologics CDMO will have a greater depth and breadth of experience in biopharmaceutical development and manufacturing. Biologics CDMOs have dedicated researchers, chemists, and experts at every stage of the development and manufacturing process.   

A collaborative effort between a pharmaceutical company and a biologics CDMO company yields innovative solutions and a smoother development process. 

Equipment and Manufacturing Facilities 

During the COVID-19 pandemic, CDMOs have played an important role in the deployment of vaccines. A part from the knowledge and expertise that have biologics CDMOs, the equipment and manufacturing facilities are others of the benefits for pharmaceutical companies. 

Because the manufacturing of biologics is so complex, it’s simply not possible to adapt small molecule drug manufacturing to make it suitable for biologics; different equipment and processes are needed. Pharmaceutical companies that have in-house manufacturing often have to face through decisions when capacities are stretched to the limit or when a new drug is introduced, requiring costly investments to ramp up production. 

Outsourcing with a biologics CDMO allows pharmaceutical companies access to the equipment and facilities they need, without requiring the capital investment to purchase or build them, proving them with the flexibility for any change that can happen in the future. 

Biologics CDMO companies are backed by private equity, giving them the funding needed to upgrade equipment and stay on the cutting-edge of development and manufacturing technology. In other words, not only does working with a biologics CDMO mean access to biopharmaceutical equipment and facilities, it often means access to some of the best equipment and facilities. 

Scalability 

Biologics CDMOs help pharmaceutical companies scale in a smarter way, because they can help meet production deadlines and increased demand by shifting production volume as needed, seamlessly adding a drug variation, and scaling manufacturing without the added expenses of labor and facility space. 

Biopharma Contract Manufacturing 

When it comes to manufacturing, a biologics CDMO must operate under cGMP in a state-of-the-art facility, taking steps to maintain aseptic conditions to protect the integrity of the biologics they manufacture.  

Manufacturing biologics means being mindful of cell culture, harvest(s), purification and modification reactions, fill and finish, storage, and shipping conditions. 

Cell culture 

A growth medium must be used to culture cells. This medium has to support all specialized cell functions and supplies essential nutrients to the cells.  

Harvest 

The cell culture is harvested by removing it from the medium. To accomplish this, a CDMO uses centrifugation, microfiltration, depth filtration, filtration, or microfiltration. 

Purification and modification reactions 

With the cell culture harvested, it must then be purified to remove host cell protein, DNA, viruses, endotoxin, aggregates, butters, detergents, and other impurities. The biologics cannot be sterilized once manufacturing is complete, like small molecule drugs, so the purification process is critical to ensure that a drug is safe for human use. 

Fill and finish 

After a drug has been purified, fill finish takes place, which involves filling vials with the biologic drug and packaging it for distribution. By following cGMP practices, biologics CDMO companies can perform fill finish while still preserving the integrity of the protein’s 3D structure. 

Storage and shipping conditions 

Because biologics are temperature-sensitive, special considerations must be taken for storage and shipping conditions. Cold chain logistics are required to preserve biologics and ensure their efficacy once they reach end-consumers. 

53Biologics: An Advanced Biologics CDMO Company 

53Biologics is a CDMO with extensive experience in decoding biologics overexpression providing services of cell line transformation, banking and characterization (cGMP if required), analytical development, process development (USP & DSP) and batches production. 

53Biologics works in a quick, proactive and efficient way, always ensuring very high-quality standards. 53Biologics is an ideal partner covering a customizable quality standard from ISO9001, to ISO13485 to cGMP. 

The cGMP manufacturing suite includes ISO Class 7 and 8 clean rooms and analytical and functional support laboratories to complete the quality product testing. The suite includes a maximum fermentation capacity of 200L mainly designed for microbial fermentation but in continuous increase since. 53Biologics is expanding its maximum fermentation capacity to 2.000L 

53Biologics is recognized as a Partner of Choice by a number of pharmaceutical companies. As your biologics manufacturing and development partner, our team is here to provide your pharmaceutical company the support you need to achieve your goals — because your success is our success. 

Learn More about Partnering with 53Biologics  

Contact us today to discuss your biologics development and/or manufacturing needs. 

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