Everything About the Parntership Between Follium BioMed and LakePharma
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Everything About the Parntership Between Follium BioMed and LakePharma

Pharma Tech Outlook | Monday, April 19, 2021

Antibody discovery scientists at LakePharma immunized a cohort of PentaMiceTM, a patented, royalty-free platform comprised of 5 specific strains of immunologically diverse wild-type mice, not long after conceiving the novel LFA definition.

FREMONT, CA: The year 2020 will be remembered as the year when the biopharmaceutical industry mobilized with unprecedented pace and creativity to create resources and therapies to stave off a catastrophic pandemic. Following the outbreak of SARS-CoV-2 (Severe Acute Respiratory Syndrome–Coronavirus 2), an unprecedented surge of biomedical discovery and initiative erupted. The development of accurate and responsive SARS-CoV-2 diagnostics has been and continues to be critical to the disease’s containment and eradication.

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Coming Up with An EffecientTechnology Is No Easy Task

Apollos Diagnostics was founded as a subsidiary of Folium BioMed (Seattle, WA) to design, produce, and market a rapid test for SARS-CoV-2. This new diagnostic test will have to meet several established and essential criteria. Folium Biomed, LLC’s Founder and President, John Alderete, Ph.D., MBA, said, “It must be compact, affordable, manufacturable, and accurate...”

The lateral flow assay is a tried-and-true diagnostic platform (LFA). The ‘sandwiching’ of SARS-CoV-2 viral particles by two separate antibodies that attach to distinct viral epitopes provides a visual line suggesting a positive diagnosis, similar to an over-the-counter pregnancy test.

“We appreciate the power antibodies have when it comes to their diagnostic capability … The core of an effective LFA test is access to specific antibodies against the viral target. While other test developers were re-purposing SARS-CoV antibodies that were cross-reactive to SARS-CoV-2…Apollos opted to reveal the most immunologically relevant epitopes from SARS-CoV-2 that would ultimately lead to highly sensitive and specific antibodies to the virus”.

The development of this new diagnostic was chosen by LakePharma (San Carlos, CA), a leading U.S.-based contract research, development, and manufacturing organization (CRDMO). LakePharma has also been recognized as “Top CMOs 2021” by Pharma Tech Outlook Magazine. Antibody discovery scientists at LakePharma immunized a cohort of PentaMiceTM, a patented, royalty-free platform comprised of 5 specific strains of immunologically diverse wild-type mice, not long after conceiving the novel LFA definition.

The Immune System Will Tell What Is Important

Several antibody discovery methods have been developed over time, including hybridoma (the “bread and butter” of antibody discovery, from which nearly 90% of therapeutic and diagnostic antibodies are derived), phage and yeast show, and single B cell cloning. Apollos was drawn to hybridomas because of his experience with them. “We know it works... and we trusted their (LakePharma’s Discovery Immunology Team’s) expertise,” said Alderete.

The Discovery Immunology Team got to work, armed with PentaMice and the knowledge gained from over a hundred individual antibody campaigns. Blood titer checks revealed a robust antibody response against the spike (S) and nucleocapsid (N) viral surface proteins after several immunizations with heat-inactivated SARS-CoV-2 virus, allowing the scientists to proceed with the hybridoma generation process.

Hundreds of lead antibodies were discovered and advanced for specificity analysis against SARS-CoV-2 proteins (e.g., S vs. N) and viral proteins present in other coronaviruses known to infect humans after a standard ten x 384-well plate ELISA primary scan.

“The discovered antibodies were truly remarkable in terms of sensitivity, specificity, and binning,” said Kathleen Kennedy, Ph.D., Director of Research and Development, Apollos Diagnostics LLC (Seattle, WA).

When designing a diagnostic, epitope binning is critical for determining if the discovered antibodies bind to the same or different epitopes on the targeted antigen. One antibody captures the SARS-CoV-2 viral particle, while another attaches to a completely different epitope and identifies the virus, allowing the patient to receive the proper diagnosis.

Bringing to Life

“Beyond its reputation, what compelled us to go with LakePharma was the continuity; from discovery to commercialization” shared Alderete. With a companywide workflow that consists of up-front due diligence in developing a strategy for maximal success for the antibody discovery campaign to lead candidate characterization and engineering to GMP process development and manufacturing, LakePharma scientists are there every step of the way.

“As a small company, we have to thread the needle. Between the regular process and what we needed to move forward, LakePharma satisfied many of our requests”. The next step: manufacturing the antibodies at a large enough scale to meet demand. GMP production of Apollos’ diagnostic antibodies are currently ongoing at LakePharma’s Hayward, California facility. GMP biomanufacturing of plasmid DNA, protein therapeutics, and vaccines is performed at LakePharma’s Hopkinton, Massachusetts site.

Clients Success is Company’s Success

Clients are sometimes referred to as “customers” by CROs. At LakePharma, the business takes pride in treating its clients as trusted partners and colleagues from the start, focusing on alignment with project priorities and working in tandem to achieve optimal success.

Moving forward, LakePharma is poised to expand additional technical abilities to meet emerging, and ever-growing customer demands. “We will add more capabilities leaning toward automation and robotics, which will help us enhance our efficiency in helping customers,” explains HuaTu, Ph.D., President, and CEO, LakePharma

“LakePharma is nothing short of a true partner with Apollos Diagnostics. We will continue to work with LakePharma as a partner for all of our future antibody development campaigns!” concluded John Alderete, Ph.D., MBA; Founder and President of Folium Biomed, LLC

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