Avoiding Heartbreak in Your Cell Line Development Partnership
Outsourcing is a valuable way to accelerate your cell line development (CLD) process, but choosing the right provider is essential to a successful relationship. In the spirit of Valentine’s Day, explore our helpful tips to finding the perfect partner (in CLD) and your “happy ever after.”
This article is posted on our Science Snippets Blog
The global pandemic has put a renewed focus on the healthcare sector, particularly within the biotech industry. According to GlobalData, the activity level within the pharma sector was 14.6% higher in the first quarter of 2021 than at the end of 2019, before the pandemic damaged economies worldwide.
These increased demands have driven successful collaborations across the pharmaceutical industry. Joint endeavors from governments, universities, and commercial R&D organizations have yielded over 200 candidate vaccines for COVID-19. Clearly, strong partnerships can speed up progress to achieve great feats, even in challenging circumstances.
One area where an external partner could be particularly beneficial is cell line development (CLD). Selecting the right partner is essential to carving out a productive relationship and reducing your time-to-market. Unfortunately, you can’t rely on Cupid’s arrow to guide your selection. Instead, you should carefully consider the following criteria in your search for the perfect match:
- Production capabilities
- Knowledge
- Reliability
- Scope
- Efficiency
- Cost-effectiveness
- Technology availability
Considering these qualities in your potential match will help ensure you have the right provider for your CLD project and pave the way for a fruitful partnership.
Production Capabilities – What Can Your Partner Do for You?
Development of a biologic with a reliable process ready for commercial production consists of many moving pieces and is both logistically and technically demanding. Between functional assays, clone selection, banking, and lot release testing - to name a few - it can be overwhelming for both small start-ups and multi-product developers to orchestrate the various units of operation within the organization.
In less than 15 years, Sartorius’s entry into CLD has completed more than 240 successful cell line development projects, along with another 50+ on the way. Many projects have been high yield products with titers greater than 5 g/L for monoclonal antibodies, in addition to other more complex and difficult to express proteins.
Knowledge – Find Someone That Inspires You
Our knowledge of producing commercial-scale biologics in mammalian cells is rooted in the success of our CLD projects. It is all made possible by Sartorius’s own developed in-house media system combined with the stable producing proprietary CHO DG44 cell line and custom expression vectors. Each component was developed to work in conjunction to create a robust, high-yielding product. The attention afforded to the DG44 cell line, as opposed to divested interests in multiple variants, has set the CHO DG44 line at the forefront.
To learn more about Sartorius’ knowledge of CLD, see this White Paper
Reliability – Choose a Partner That Won’t Let You Down
The knowledge gained from developing an in-house media system and cell line has not only built a strong track record but has also reduced processing risks, generating predictable results to ensure client critical quality attributes (CQAs) can be met. After physio-chemical assays, validation, and scale-up initiatives may be executed to evaluate if product quality is maintained from pilot to commercial scale.
By incorporating design of experiments (DoE) principles from MODDE®, multivariate data analysis from SIMCA®, and parallel Ambr® systems, reliable models of 500-fold scaling are fortified with statistical data. This limits the need for laborious process optimization rounds and saves approximately 3 months of work.
To learn more about how Sartorius uses multiple units of operation to create new robust processes, see this poster (Harnessing data analytics and Ambr® systems for developing a robust and scalable platform process from clone selection to fed-batch production).
Scope – What Else Can They Bring to the Table?
In addition to development-related services, several cell line manufacturers can supply other relevant services (e.g., cell line characterization, cell banking, cell bank characterization, process development, and commercialization of reagents/equipment). However, few are able to provide the depth of services an integrated provider such as Sartorius can. Creating the tools, secure supply of consumables, and supplying services necessary to accelerate the process of developing new and better therapies are at the core of Sartorius’ values. The comprehensive portfolio of offerings allows the flexibility to adapt to the customer’s varying biologic needs.
Efficiency – Your Partner Should Keep Up With Your Pace of Life
With such a variety of client needs, some service providers may decide to disperse projects to multiple entities to reduce costs, gain access to specialists, or complete projects more quickly. However, this can cause unforeseen logistical burdens, such as organizing multiple contracts, shipping materials back and forth, potential blackout dates, shifts in priority from partners, etc.
In an integrated partner with a one-stop-shop mindset, hurdles are abated and are virtually non-existent to the end-user. With one dedicated point of contact assigned per project from DNA to characterized research cell bank, one contract is agreed upon to dictate the services to cover within the CLD service, characterization, cell banking, functional testing, and biosafety testing. The same dedicated client manager will also manage supplier interactions, scheduling, tech transfers, and ensure compatibility for the scope of work, preventing errors and streamlining the process. This makes it possible to achieve a timeline of 14 weeks from DNA to characterized research cell bank from one partner.
Cost-Effectiveness - They Should Also Keep Up With Your Way of Life
Collaboration with a dedicated client manager can not only prevent unseen risks and accelerate development, but it also has the potential to reduce costs to the client. The client managers not only coordinate projects but are also equipped with the expertise to provide recommendations and guidance for tests to include or exclude.
These benefits are bundled without licensing fees, royalties, milestones, or success fees, keeping the offer service-based. Alternatively, a technology license is also available to generate a research cell bank in-house with the materials, protocols, and expertise behind the Sartorius brand.
Technology Availability – Are They Up to Date with the Latest Trends?
As biologics become increasingly complex and the demand for greater titers increases, it is important for a CLD partner to stay ahead of the curve both in execution and their offering. Implementation of automated high-throughput systems such as CellCelector™, Octet®, iQue®, Ambr®15, and Fill-It can save significant employee hours, optimization time, and resources on large screening projects. Integrated analytics within these consolidated platforms can quickly provide robust data and reduce process variability, enabling accelerated decision-making of the ranking and selection of clones.
These tools have offered additional solutions beyond the traditional fed-batch clones, such as high inoculum cell banks and perfusion-ready clones.
Find out more on the importance of selecting a clone for the right application and why a perfusion process may be suitable for you
Asking the right questions during your selection process is essential to choosing a reliable CLD partner and forging a successful relationship. Considering the above qualities in your potential match can help establish expectations on both sides and escape any potential heartache.