Antibody development and antibody expression have become essential in life-science and the biopharmaceutical industry. In particular, advanced methods of creating and selecting recombinant antibodies have enabled science and medicine alike to progress in unanticipated speed.
Most impressively, within one year after the WHO declared the COVID-19 outbreak a global pandemic, multiple reports of SARS-CoV-2 neutralizing recombinant antibodies have been published. Generally, novel technologies and pressing needs spark races to bring innovative solutions to the patients.
This article highlights why speed matters for success in the biopharmaceutical industry, and how organizations can foster their success by focusing on these three topics: proper planning of a project’s timeline and in-house resource availability, avoiding bottlenecks in supply of key materials, and resolving issues by outsourcing to a trusted external service provider.
“Time is money.” Frankly, everybody thinks or hears this phrase probably more often than a few times per week. In the biopharma environment, there are two sides to this coin:
What is your project’s burn rate? Biopharmaceutical product development involves highly skilled teams, pricey equipment, tightly regulated production environments and demanding markets. Naturally, this development phase is capital intensive and needs to be kept as short as possible, and it is essential to be concluded prior to running out of funds.
The first player on the market has a tremendous advantage over late arrivals. He enjoys reaping 100% of the market share to cover his development costs. Subsequent players begin the uphill battle for their piece of the cake later on. This time period must be stretched as long as possible.
Everyone in the biopharmaceutical field agrees that the competition is fierce. This industry sector strives to improve and prolong people’s lives. Consequently, the world’s brightest heads are drawn to this field. They are highly motivated to put in their share in the lab, in the clinic, in managing regulatory processes.
Competitors push hard to develop the best product in terms of efficacy, safety, patient compliance and to bring it to the market as fast as possible. Naturally, the best product will force inferior solutions out of the market, reducing their chances of covering development costs.
From the moment of insight, innovation or proof of concept experiments, until a product is brought to the market, the development endeavor is a race. The winner enjoys several advantages:
· leverage in pricing the product
· creating trust and traction with key opinion leaders
· establishing networks with sales and distribution partners
· building strong relationships with customers.
Success in the antibody field relies on the ability to maximize speed to market. However, projects seldom progress smoothly. Reproducibility issues, key materials become in short supply, production lines may vary in quality. Countless factors can make the race to market a bumpy ride.
Efficient use of off-site resources to express antibodies proves to be crucial, when such problems have to be resolved. And they better be resolved quickly.
Tapping the experience and production infrastructure of trustworthy service providers is invaluable in such circumstances.
Proper planning allows project leaders to anticipate delays and supply shortages well in advance and take necessary steps to mitigate problems before they become serious. When additional resources are needed, there should be a plan in place to enlist a service provider to bridge supply shortages in a timely manner.
Moreover, it is oftentimes economical to engage in extended collaborations with external service providers. They bring ample experience to the table and provide frameworks for collaborations in their field of excellence in order to minimize time to market.
During research and development, certain processes are identified as rate-limiting, e. g. demanding experiments, or shortages in production volumes of quality materials. Those issues are usually tracked back to a lack of resources inside an organization that is moving into a new field.
Service providers are often able to resolve these issues by supplying specialized expertise, external resources and established infrastructures for short-term projects, as well as longer term commitments.
Outsourcing to trustworthy service providers is an efficient way to circumvent such issues. Enlisting service providers is leveraging on outside sources of:
· time for experimentation
· expertise and skills in innovative fields
· highly specialized infrastructure and equipment
Thus, service providers are capable of making timely delivery of goods or services more economical than relying on in-house processes. Therefore, every organization should analyze whether establishing in-house processes is their best option.
Organizations should take a close look at their own capacities and focus on their own strong sectors, while complementing their weaker areas with outside strength.