We shared an overview on Abzena following our investment in July. Over the past few months, Abzena has launched a new facility in San Diego and has made several executive hires. We recently spoke with Sven Lee, Chief Business Officer at Abzena, and he provided us with an update on the company, it’s services, and it’s growth.
Sven Lee – AbzenaSven Lee – Abzena

Can you describe Abzena’s business?

Abzena is a contract development and manufacturing organization (CDMO) involved in the discovery, development and manufacturing of biologics and antibody drug conjugates (ADCs) used for biopharma companies globally. Abzena does not produce these to commercially sell on the market ourselves, but manufactures these for numerous therapeutic indications for biopharma organizations. We can start in the earliest phases of discovery and continue through to manufacturing for all phases of clinical trials and, more recently, smaller scale commercial manufacturing. We can produce many different types of proteins and antibodies, as well as, antibody drug conjugates (ADCs), used for cancer and other indications.

How is Abzena different from other CDMOs?

The two things that distinguish Abzena are the expertise in achieving complex development in chemistry and biologics, and the way we closely and flexibly partner with our customers to help ensure success to get them quickly to the clinic. The most important aspect of early development is getting an effective product into clinical trials. In the case of bioconjugates, this could be a delicate balance of a carrier protein linked through chemistry to a complex payload, or warhead, to target a specific disease. This takes a highly talented team coordinating and understanding our partner’s therapeutic goals.

Though we regularly work with some of the largest global pharma companies, unlike many large CDMOs, Abzena also works well with small to mid-sized biotech organizations with the flexibility and speed needed to allow them to be successful in their development programs. We have the capacity, flexibility and extensive experience for smaller biopharmas that large CDMOs often cannot provide the them. This has led to record sales in 2020.

What specific expert solutions does Abzena provide?

One of the most important aspects of getting a product into clinical trials and then to commercially manufacture it, is the early development phase. Determining the developability and manufacturability of a potential therapeutic takes years of experience, talent, and equipment to help move programs forward. The work we do in Cambridge and Bristol for biologics and complex small molecules is instrumental in ultimately allowing a project to move into the process development and manufacturing stages for clinical trial. Assessing potential immunogenicity complications, which could result in side effects in patients, ensuring the formulation of the final product and also stability is done early in the development of the molecule. Abzena has years of experience in solving these challenges.

How many sites do you have and where are they located?

Abzena is located in three places globally. We have the Cambridge UK facility that is the center of excellence for our early discovery and development of biologics. We have an antibody discovery platform, developability, including humanization, immunogenicity assessment, cell line development to research cell banking and formulation. Additionally, bioassay and bioanalytics are conducted in Cambridge UK.

The second site is in San Diego, where we have master cell banking, process development and cGMP manufacturing of proteins in four GMP suites that go from 500L to 2000L bioreactors. The suites are capable for manufacturing early clinical trial material through Phase III and commercial manufacturing. The San Diego sites for mammalian manufacturing have also passed the California FDB inspections for registration, without any observations.

The third location is Abzena’s chemistry process development and cGMP manufacturing site in Bristol PA, near Philadelphia. We have two GMP suites for small molecules and bioconjugation for project such as antibody drug conjugates (ADCs). Again, these suites are for clinical trial drug manufacturing through phase III.

Congratulations on winning the Best CRO Award at the World ADC conference. To what do you attribute your success?

We’re very pleased to be recognized as the best CRO this year. Producing ADCs is very complicated. It is a balance of producing a good protein carrier, often an antibody, and linking it with a payload molecule, such as a cytotoxic chemical for cancer. The linker between the protein and the payload requires deep expertise and know-how. Abzena has produced hundreds of these combinations for many companies globally. Abzena can produce all the components and provide all the testing and analytics necessary to help ensure that our partners receive the best possible product for clinical trials.

How has Abzena managed through COVID-19?

Although COVID has been challenging, Abzena has managed well during this period with strict internal testing and travel policies monitored on a weekly dashboard. This has allowed for continuity of business at all three of our sites. In addition, we have prepared for potential supply chain interruptions by ordering additional materials, where possible, to try to mitigate some of the long lead times for raw materials for client projects. Although travel has been limited, we are conducting many live virtual tours and audits for our customers. We are also working on several COVID projects for our clients.

Are you hiring?

We have recently hired new site heads at San Diego and Bristol PA. The new leadership at these sites will propel these locations to the next level of development and commercial manufacturing. We are rapidly growing our team and we are hiring for several roles in the US and in the UK.