Many small or startup biotech companies lack all of the resources, facilities and expertise to carry out their business in its entirety, alone. The common solution to this is outsource certain tasks to a
CSO, when it makes financial sense or saves precious time. The following is a list of the many options for outsourcing from contract R&D to manufacturing to virtual office assistance.
1. Molecular Biology/ Protein Characterization
If you don't have all the laboratory equipment to carry out every
molecular genetic technique in the book, look at outsourcing to a lab that specializes in techniques like
DNA sequencing or gene cloning, for example.
2. Fermentation Development
Maybe genetics is your forte and you've cloned the gene you want, now you can hand your new
GMO off to the specialists in
fermentation and let them figure out the
optimum growth conditions for larger scale production.
3. Purification
Now it's time to purify your bioproduct. Many companies specialize in
protein purification methods and have the scaled up systems in place for batch processing. If you are a smaller biotech startup, it's likely more cost-effective to farm this one out, at least while still in clinical trials.
4. Pre-Clinical Testing
Not too many people know all the in's and out's of getting a product to clinical trial. Consulting with the experts, knowledgible of all the safety, documentation and
data-sharing requirements will help expidite your progress.
5. Regulatory or Patent Filing
Another area where experience and specialized know-how puts you at an advantage is when it comes to filling out the complex paperwork and/or legal documents associated with filing for approvals or patents. Biochemists who specialize in laboratory procedures
can't be expected to know everything about the approval process and expert legal advice can help you maximize returns on your investment by protecting your
IP.
6. Quality Management
Implementation of a
quality management program involves proceedings and paperwork that only the experts can wade through without undo stress.
IT management and data storage might also fall under this category, since accurate record-keeping is part of the QA/QC process.
Technical writing is another area where quality and consistency are required, and a proficiency in writing is an asset.
7. Office Administration
You may or may not know all there is to know about accounting, filing taxes, payroll and other administrative duties, but finding time to do it is another issue. Finding an expert, even a part-time or temporary service during busy times of the year, can leave you free to focus on product development. Other areas of business management that are often outsourced include staffing/recruiting, IT outsourcing, and administration of health and safety programs.8. Manufacturing
When a new drug goes to clinical trial, it might not always be economically advantageous to design and/or build a production facility capable of providing enough high quality drug for testing. Some CSOs specialize in processing batches of biologicals or pharmaceuticals that meet quality control criteria. Outsourcing of full-scale production, or the manufacture of
active ingredients might also be cost-effective choices for biotech startups.
9. Packaging and Marketing
It's not uncommon to hire a marketing company to assist with publicity, advertising and promotion in any business. Experts in this area might also assist in the design of packaging, for aesthetic appeal. When it comes to regulatory requirements, however, consultation with professionals who know the laws of the target country could save much time and avoid complications.10. Business Development
Many startups obtain their funding from venture capital and the
role of a venture investor is often to be somewhat involved in development of the
pipeline. These and other business experts can help you stay focused and achieve your business goals, especially if your strengths lie predominantly in the research department.
