What is Drug Substance CDMO Services and Why Do We Use Them?

As drug substances become increasingly complex, pharmaceutical companies are facing many challenges developing and manufacturing drug substances. More rapid innovation and production is needed to bring solutions to market faster, and keeping expenses in check, or even reducing costs, is top of mind for many pharmaceutical companies.

With high costs of equipment—and the wide-range of equipment needed for sterile liquid dosage, liquid and semi-solid dosage, and solid dosage forms—partnering with a contract development and manufacturing organization (CDMO) or contract manufacturing organization (CMO) can help pharmaceutical companies bring new products or formulas to market without investing in additional infrastructure to support it.

CDMO vs. CMO: What’s the Difference?

A CMO is a contract manufacturing organization. Just as the name implies, CMOs are contracted by pharmaceutical companies to manufacture drug substances. Manufacturing may include solution, emulsion and nano-suspension, liquid-filled capsules, aseptic filling, terminal sterilization, pre-filled syringe and vials, and tablet and capsules.

Many pharmaceutical companies find themselves tapping into a partner for drug manufacturing because equipment for mass production of some chemicals is very cost prohibitive. It’s more cost effective to outsource than to invest in equipment costs, especially if a product fails in clinical research and further development and production are canceled.

A CDMO is a contract development and manufacturing organization, meaning they not only handle the outsourced manufacturing of drug substances, but also all of the innovation and development work that occurs prior to manufacturing one. This includes development, production and analysis, and pharmaceutical companies no longer need to build and staff dedicated innovation and manufacturing facilities.

Services often offered by CDMO companies include formulation, analytical services, blending, coating, converting, packaging, serialization and shipment. CDMOs can start with a concept or a ready-to-go formula, with preformulation and formulation development services available, as well as clinical trials and commercial production.

When pharmaceutical companies find the right CDMO, they gain flexibility, collaboration and innovation services to help increase speed to market and lower costs by providing expertise and equipment they don’t have in house. As drug substances become more and more complex and rapid innovation and production are needed, CDMOs can accelerate drug development and improve pharmaceutical companies’ bottom lines.

What Is a CRO?

A contract research organization (CRO) is hired by pharmaceutical, biotechnology and medical device manufacturers to handle clinical trials after the drug is developed by the CDMO and is ready for testing. CROs plan, coordinate, execute and supervise all processes involved in developing and running a clinical trial, including selecting a site (when applicable), recruiting participants, monitoring the trial, managing data and more. A CRO manages feedback and requirements from multiple constituents, including manufacturers, trial sponsors, ethical committees, foundations, researchers, legal departments, trial participants and regulatory agencies.

Some CDMOs offer research services themselves or can refer their pharmaceutical company partners to a trusted CRO as needed.

Why Pharmaceutical Companies Need CDMOs

Drug development is complex, and when pharmaceutical companies find the right CDMO, it not only helps them meet deadlines or quickly scale up to meet production demand, but also save cost and time.

• Reduce infrastructure costs by reducing or eliminating the need to invest in additional production and manufacturing space, and eliminate costs associated with purchasing specialized equipment, since the CDMO has access to equipment and facilities.

• Access additional expertise by tapping into researchers with specialized skills—and a wide breadth of experience—to meet the needs of their drug development project and reduce their own payroll costs.

• Meet production deadlines and increased demand with the ability to shift production volume, add a drug variation or scale up without the added expenses of labor, facility space, etc.

What to Consider When Choosing a CDMO Partner

Here are a few factors to consider and questions to ask yourself when selecting a CDMO partner for your pharmaceutical company:

1. Access to and experience in the technology and science needed for your drug molecules — Are you in the early stages of drug development? As the formulation is being developed for your molecules, finding a CDMO with experience in a variety of formulation technologies can help optimize your drug development. Some difficult formulation challenges require nanotechnology, and Ascendia developed three patented nanotechnologies to help improve biopharmaceutical properties.
2. Right-sized and properly equipped facilities — Looking for a CDMO for complex injectables development? Matching the equipment scale and material handling expertise with the product batch size is essential to ensure a successful, cost-effective outcome. Evaluate the facility to ensure it has the equipment and monitoring needed for your drug development, such as the class 100 clean room suites, laminar flow hoods, biosafety cabinets, isolators and restricted access barrier systems (RABs) available at Ascendia. Additionally, the CDMO must operate under current good manufacturing practices (cGMP), which is necessary for compliance with regulatory guidelines.
3. Ability to keep costs and timelines in check — Controlling costs during early stage drug development, as well as sticking to a realistic, though likely very aggressive timeline, relies on the knowledge of an experienced team who’ve worked with the advanced technologies and state-of-the-art facilities for other pharmaceutical companies and can help you do the same, just like Ascendia. Be sure to ask your CDMO partner for a complete view of costing, including the cost differences between batch sizes and larger runs.
4. Experience in the field — Look for a CDMO with an experienced team that can formulate to the specific molecule. They will be able to assess the compound’s physical and chemical properties, evaluate the drug and its intended target site, and recognize the drug’s uptake. The CDMO team will also need to understand particle size reduction, solid dispersion and lipid-based approaches. These are all key factors when working with small molecules.
5. A Fit With Your Company — Lastly, but most importantly, evaluate whether or not the CDMO partner you are hiring fits with your organization. Do they offer the flexibility, collaboration and innovation you need? Is their culture, leadership and communication style a good fit? Do you feel comfortable handing your baby (drug development project) to them to care for? Do they have the experience your project needs? For example, Ascendia Pharmaceuticals has a highly experienced management team that consists of PhD-level scientists and MBAs with 100+ years of combined pharmaceutical experience.

What an Effective CDMO Partnership Looks Like

A partner is someone (or an organization) who is aligned with your organization and wants to help you achieve your goals. When selecting a CDMO partner, you should look for one who has your best interests in mind, and that comes down to what type of relationship you have with your CDMO partner. Is it rigid with very structured agreements, or flexible to fit the drug development project at hand? Are they able to meet your current needs and help you look (and plan) ahead to future needs?

Another key differentiator of a good partner is their onboarding and collaboration practices. It can be very challenging and cumbersome to transition your drug development to a CDMO who considers you just another client. Find one with top-class communication, opportunities for collaboration and frequent adjustments and access to key project partners to help make the knowledge transfer smoother.

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