Contract Manufacturing For Outsourcing Pharmaceutical Production
What is contract manufacturing?
Contract manufacturing is a form of business process outsourcing (outside resourcing for internal processes). Some outsourcing services include product development, product manufacturing, pharmaceutical lab testing, and product packaging. As the name of the term “contract manufacturing” implies, a contract manufacturing company creates an agreement (contract) with another business (company A) to complete a planned or existing task. Thus, company A hires the manufacturing company to complete activities that they can’t do in-house or don’t wish to achieve internally. Utilizing the services of a contract manufacturing company can supply a host of benefits, especially to startups or small companies. Nearly all pharmaceuticals have some level of outsourced manufacturing (contract manufacturing) or pharmaceutical lab testing (contract testing) to get a new drug approved by the Food & Drug Administration for patient use.
What are examples of pharmaceutical formulations where the manufacturing is outsourced?
- Metered-dose and dry powder inhalants
- Nasal sprays
- Optics
- Vaginal suppositories
- Topicals
- Rectal suppositories
- Oral liquids (aqueous)
- Liquid-filled capsules
- Oral tablets and powder-filled capsules
- Parenteral products
What are the benefits of contract manufacturing?
There are a few different reasons to use an outside company to support product development and manufacturing:
#1: Cost savings
Companies save money instantly because they do not have to pay startup costs for a facility, equipment, and technicians needed for product production. Additionally, companies save money on employee hiring, wages/benefits, and training. If hiring a contract manufacturer overseas (such as India), additional cost benefits can be found due to the lower labor cost. As contract manufacturers serve multiple customers and buy in bulk, they can often offer reduced raw material costs. While all of these benefits are obvious for startups and small companies with limited startup capital and resources, large corporations benefit from using contract manufacturing through outsourcing the production of products outside of their core competencies.
#2: Advanced technical skills at your fingertips
Businesses can use the contract manufacturer’s engineers, scientists (chemists, biologists, process development specialists, and pharmaceutical lab testing technicians), regulatory experts, and technicians with years of experience to their advantage. These experts’ skills are necessary for cosmetic production and provide efficient outsourcing services for formulation creation, prototypes, and product filling methods.
#3: Instant access to GMP quality facilities & processes
Facilities with outsourcing services that are certified for Good Manufacturing Practices (GMP) (including pharmaceutical testing labs) require ongoing environmental monitoring to maintain certain levels of sterility and excellence. Instant access to GMP quality facilities circumvents the headache of startup facility costs and lengthy certification processes.
#4: Allows outsourcing business to focus on branding depth
With outsourcing services (like manufacturing or pharmaceutical testing labs) that aren’t a company’s expertise, businesses can focus on their core competencies and building their corporate brand. Thus, new companies can focus on depth over breadth.
#5: Gives outsourcing business access to niche internal product knowledge
Many cosmetic brands are founded by celebrities and entrepreneurs who do not have chemistry, biology, or manufacturing backgrounds. Celebrities and entrepreneurs have a product vision but don’t have the expertise to successfully create and market the concept alone. Working with a knowledgeable manufacturer fills that gap. Even for large corporations, outsourcing services (like manufacturing) can offer benefits if the niche a corporation is looking to fill can be covered cost-effectively.
#6: Time savings
With a contract manufacturing organization, businesses do not need to hire staff, train technicians, or acquire resources for manufacturing. Instead, contract manufacturing activities (or any other outsourcing services) can run in parallel with other areas of your product development, testing, and scale-up. The time savings available make business process outsourcing a wonderful decision for most pharmaceutical companies.
Pharmaceutical manufacturing has the following product manufacturing stages:
- Initial research and development to find drug and prove efficacy
- Small batch manufacture of active pharmaceutical ingredient (API)
- Large batch manufacture of API
- Small batch manufacture of final drug product
- Large batch manufacture of final drug product
- Packaging and labeling for a final drug product (including sterile filling for liquid, gel, and cream formulations)
Cosmetic manufacturing has the following basic product manufacturing stages:
- Initial research and development to create the cosmetic formulation
- Small batch manufacture of cosmetic product
- Large batch manufacture of cosmetic product
- Packaging and labeling for final cosmetic product (reiteration of packaging if necessary)
If formula development isn’t necessary, most of the manufacturing cost will go to getting manufacturing in place to produce large-scale cosmetic batches.
Initial research and development stage
Initial research and development (R&D) are often performed in-house until enough information for initial patient filing can be produced. Later process development and refinement for new drugs are then outsourced to contract manufacturing companies capable of making drug production cheaper and scalable. Pharmaceutical business process outsourcing may include R&D activities if resources are cheaper or timelines are faster.
Small and large batch manufacture of API
Once a promising new drug has been discovered, benchtop lab production needs to be scaled up to batch sizes of at least one hundred grams. This small active pharmaceutical ingredient batch production enables process development and troubleshooting that can be used for later large batch manufacture. Small batch manufacture of API is an important step in process development as it provides proof-of-concept of product production without the risk of utilizing large quantities of expensive raw materials. Large batch manufacture (on the scale of kilograms) is used to produce batches of API used for animal studies and drug product manufacture. Consider making your large batch manufacture large enough to cover your initial drug product manufacturing and animal testing needs.
Small and large batch manufacture of drug product
The drug product is a mixture of API with other ingredients to form oral tablets, pills, powders, topical creams, or solutions that a patient will utilize for disease treatment. The drug product base must be able to keep the API stable. In the case of oral tablets, a coating may be utilized to provide better patient mouthfeel, support product banding, or provide delayed release of the oral drug product. As with API batches, drug product creation begins with process development for a successful small batch, followed by the production of large-scale batches used for clinical trials and stability testing. The drug product will often need to be created for API and placebo versions of the drug for clinical trial use, unlike API production. Drug product creation is another great example of common business process outsourcing for pharmaceutical companies.
Product packaging
Business process outsourcing is often used for product packaging. Product packaging needs are based on the formulation of the pharmaceutical. For oral tablets, the product packaging is traditionally bottles or blister packs. For small volume parenteral products and liquids, the packaging is vials or syringes. Large-volume parenteral products utilize bottles or plastic bags. In contrast, topical formulations (creams, ointments, and gels) are filled in bottles or tubes. Powders may be filled in bottles or self-contained, single-dose pouches. Product packaging is also the stage where product labeling and branding for your drug come into play. The contract manufacturing needs for product packaging will depend upon the formulation of your drug. Here at MycoScience, we specialize in syringe and vial fillings.
Contract testing for safety and efficacy
In parallel with drug product manufacturing, a series of tests (in vitro, in vivo large and small animal testing, and Phase I-III clinical trials) must be completed before new drug approval. Some tests will be contracted out to contract testing facilities and corporations specializing in clinical trials. For more information on the differences between contract testing and contract manufacturing, please read THIS article.
Summary
Overall, contract manufacturing is a form of outsourcing where a third-party manufacturing company is hired to complete activities that cannot be accomplished internally. Utilizing the services of a contract manufacturing company can supply a host of benefits, especially to startups or small companies. These benefits include cost savings, time savings, access to advanced technical skills outside a company’s expertise, and other benefits like manufacturing GMP quality products. Pharmaceutical manufacturing for new drugs has multiple stages: initial research and development stage, small API manufacturing stage, large API manufacturing stage, small drug product manufacturing stage, large drug product manufacturing stage, and product packaging stage. When looking to engage with a contract manufacturing organization for pharmaceutical production, ensure that the signed master services agreement covers all of your product’s intellectual property, quality, timeframe, formulation development, and packaging needs.
MycoScience is a contract manufacturing organization specializing in sterile syringe and vial filling. MycoScience also offers Preservative Efficacy Testing, Sterilization Validations, Bioburden Testing, Cleaning Validations, Microbial Aerosol Challenge Testing, Accelerated Aging, Microbiology Testing, Cytotoxicity Testing, Bacterial Endotoxin Testing, EO Residual Testing, Package Integrity Testing & Environmental Monitoring services medical devices and allied industries. MycoScience is an ISO 13485 certified facility.
References
Contract Manufacturer. Wikipedia. 2021.
Michael J. Akers. Sterile Drug Products Formulation, Packaging, Manufacture, and Quality. Drugs and the Pharmaceutical Sciences. Informa Healthcare. 2010.
