The global oral solid dosage contract manufacturing market recorded sales of $23.4 billion in 2021, and is predicted to reach $43.6 billion by 2032.1 This can be attributed to the specialized capabilities these CDMOs offer to support pharmaceutical companies in their OSD development. As you seek a CDMO partner, consider these 10 attributes that can ensure a successful, faster, and cost-effective OSD tech transfer.
1. Experience in all Phases of Manufacturing
A CDMO with many years of experience in every stage of oral drug manufacturing — pre-IND, IND, NDA, ANDA, NADA, ANADA, Phase I, II, III, IV (CTM manufacturing), and commercialization — is invaluable. Each phase carries different regulatory considerations, different scales of manufacturing, and different financial priorities. A staff with experience in all phases will be better equipped to smooth over any hiccups during the transfer and beyond.
2. Mastery of Oral Drug Development Techniques
For successful oral drug tech transfer, a CDMO must understand and master all relevant techniques involved in most tech transfers. Examples for liquid-based systems include enhancement of solubility and bioavailability for poorly soluble compounds by solubilization with GRAS solvents for the desired drug load, lipid-based systems/self-microemulsifying drug delivery system (SMEDDS), nanosuspension, and inclusion complexes. Solid dosage forms include spray drying, roller compaction, tableting/encapsulation, etc.
3. Oral Drug Facilities
A CDMO for oral drugs should have cGMP and FDA-certified facilities, clean rooms, and equipment to produce gelatin capsules, tablets, capsules, and non-sterile liquids/suspensions. Your CDMO will need containment facilities if you use highly potent compounds, cytotoxic materials, hormones, and DEA-controlled substances I-V. Bonus if your CDMO can source high-quality raw materials and excipients at reasonable rates.
It is helpful if your CDMO is in one location and offers a gamut of services: project management, formulation and process development, supply chain management, technical services, validation, primary and secondary packaging, quality assurance and quality control, analytical and microbiological testing capabilities, and regulatory support. With one campus, it is easier to use the continuous manufacturing (CM) method to feed material through all the operations in a single equipment train. Being on the same campus also allows for simpler logistics, less supply chain risk, better control of temperatures and humidity, and one quality control and quality assurance system.
5. Cost Efficient
A CDMO should be able to deliver cost estimates and project timelines, all within a week of beginning the technical assessment. The CDMO must be aware of the budget at all times and have a record of saving sponsors money without losing product quality. Make sure your CDMO has a track record of delivering drugs to market quickly and efficiently, from pre-clinical to commercialization.
6. Expertise with Complex Products
While complex products are gaining popularity, and there are hundreds of advanced delivery platforms in development, only a handful of CDMOs can handle them. If your oral dose product is a complex formulation, a CDMO with experience in complex dosage forms, small and large molecule compounds, niche tech, NCEs, and NDAs is necessary for the tech transfer. Your prospective CDMO should also be able to handle complex processing challenges like milling/particle engineering, spray drying, extrusion, and particulate/bead coating.
7. Efficient Supply Chain
Due to the supply chain disruptions it can take longer, often three to six months, to get materials from a manufacturer. But a CDMO with strong supplier relationships will not run out of supplies easily. For raw materials and packaging components, a CDMO must be in the practice of ordering as early, and as much, as possible to cover worst-case scenarios. Once that contract is signed, orders should be made within a week because timeframes are currently extensive. Your CDMO should be clear and upfront about their process and progress. It should update you regularly about any supply chain issues until they are resolved.
8. Regulatory Support
Your CDMO must have regulatory experience to guide the tech transfer as per the current FDA regulations. Evaluation of the product specifications and analytical test methods against the current or new USP requirements needs to be done at the initiation of the transfer process. Due diligence on regulatory aspects during tech transfer helps to get faster approval from the agency.
9. Awareness of International Standards and Requirements
Corporations are increasingly opting to send manufacturing overseas to cut costs. This has caused significant changes in how oral drugs are regulated. The requirements for APIs and excipients can vary from one country to another. More rigorous guidelines and inspections are being put into place to ensure compliance across borders. Packaging preferences can also vary from country to country.
For primary packaging, the US often favors bottles, where Europe prefers blister packaging. A CDMO must know these differences and make every effort to keep the product compliant in international markets.
10. Pharmaceutics Know-How™
Having a team with decades of experience in developing dosage forms can be invaluable in the early stages of development, as they also have the foresight to look down the road and anticipate any potential future challenges, such as physical instability of the dosage form (i.e., crystallization of amorphous API, particle size growth of wet milled material, or crashing out of API from the supersaturated lipidic formulation). Hence, selection of the right CDMO that has the overall Pharmaceutics Know-How™ to bring the product to the market will dictate the final success of the project.
Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) located in Hunt Valley, Maryland. The experienced scientists, engineers, and staff at Pii pride themselves on adroitly employing a phase appropriate method of drug development for the prudent use of their customer’s resources as they solve challenging problems. In addition to offering end-to-end development services, Pii manufactures a variety of dosage forms to include complex parenteral drugs and has a wealth of analytical testing capabilities. Its Hunt Valley campus has four aseptic suites with lyophilization capabilities. Our talented professionals stand ready to help!