Case Study

GPN Vaccines

It can take several months—even years—to successfully develop a groundbreaking pharmaceutical product. Moving the product into manufacturing and clinical trials can take even longer.

There's good news: working with an experienced CDMO with the capacity to speed up the process can save months of development time.

BioCina recently developed a robust manufacturing process for GPN Vaccines, a biotechnology company that developed a broad-spectrum pneumococcal vaccine. BioCina worked closely with GPN Vaccines to transfer its newly developed vaccine to manufacturing, develop a reliable manufacturing process, and get it to clinical trials faster than expected.

THE PROBLEM:

Bringing a Vaccine Out of the Lab and Into cGMP Manufacturing

Streptococcus pneumoniae is a bacteria that can cause life-threatening pneumonia, meningitis, and sepsis, as well as otitis media in children. GPN Vaccines developed a ground-breaking broad-spectrum vaccine against Streptococcus pneumoniae that has the potential to save up to two million lives each year.

However, GPN Vaccines’ most substantial challenge was yet to come. After the company achieved favorable preclinical results, it had to develop a reproducible manufacturing process for the vaccine to be used in clinical trials. Unfortunately, GPN Vaccines didn’t have the manufacturing capacity. That’s when it turned to BioCina. GPN Vaccines chose BioCina for its gold-standard quality, regulatory affairs management, microbial expertise, speed, and manufacturing capacity.

We realized a good CDMO partnership was the only path to successfully manufacturing our therapeutic.

- Tim R. Hirst, Ph.D.Chairman and CEO, GPN Vaccines

BioCina’s Solution:

Fast, Flexible Process Development and Manufacturing

SPEED

BioCina understood that GPN Vaccines needed to get the manufactured vaccine into clinical trials as quickly as possible. Working with GPN Vaccines, it formulated a reliable manufacturing process for the vaccine and achieved a suitable clinical batch of vaccines in ten months.

“Having made the decision to work with BioCina, there was an urgency to move that project forward quickly, and BioCina responded fantastically, and it was very successful.” – Tim R. Hirst, Ph.D., chairman and CEO, GPN Vaccines

DIVERSE MICROBIAL EXPERTISE

The bacteria GPN Vaccines used to make its S. Pneumoniae vaccine is not commonly used among microbial CDMOs. BioCina worked closely with GPN Vaccines to devise a process for its bacteria.

“We know a lot about this organism. We know how to cultivate it, and produce it in the laboratory, but actually producing it at scale to GMP standards is where the expertise of an experienced CDMO like BioCina comes in.” – Tim R. Hirst, Ph.D., chairman and CEO, GPN Vaccines

PROCESS DEVELOPMENT

BioCina’s extensive experience in the development of fermentation, product recovery, refolding, chromatography, filtration, tangential flow, and hollow-fiber filtration operations allowed it to streamline process development for this vaccine.

“The nice thing was that BioCina had specific expertise around one particular step of the process that we were really looking for: optimizing the filtration processes in the downstream process.” – Tim R. Hirst, Ph.D., chairman and CEO, GPN Vaccines

MANUFACTURING EXPERTISE

With its rich history and experience in pharmaceutical manufacturing, BioCina transferred the vaccine into a manufacturable format. BioCina’s high-quality and cost-effective microbial process development and flexible manufacturing solutions paved the way for the vaccine’s success.

“The GPN team has a wealth of knowledge in their vaccine, and the BioCina team had the technical expertise to formulate a manufacturable process for the vaccine. The way the two companies worked together around the technical elements was essential to overcome the challenges along the way.” – Tim R. Hirst, Ph.D., chairman and CEO, GPN Vaccines

QUALITY AND cGMP MANUFACTURING

BioCina’s facility has been inspected and approved by the US FDA and Australia’s TGA and manufactures with strict adherence to regulatory requirements. As a result, BioCina’s facility was the ideal setting to develop GPN Vaccines’ manufacturing process and produce validation batches at high standards.

“One moment that remains memorable is the day our auditor returned from an audit of the BioCina facility and reported, ‘This is a gold standard quality management system and regulatory affairs group.’ That high level of confidence was essential in setting the foundation for effective collaboration.” – Tim R. Hirst, Ph.D., chairman and CEO, GPN Vaccines

The Benefits of Working with BioCina

Successful Transfer Out of the Lab and Into Manufacturing

GPN Vaccines developed its pneumococcal vaccine but faced its biggest challenge yet: developing a reproducible manufacturing process. BioCina quickly transferred the vaccine to a suitable manufacturing format. Samples were analyzed collaboratively to ensure that the vaccine remained effective.

Robust and Reliable Manufacturing Process

BioCina didn't just manufacture the vaccine; it worked with GPN Vaccines to develop, optimize, and refine a rigorous manufacturing process. Most microbial manufacturers are not agile enough to work with S. pneumoniae. However, BioCina formulated a quality manufacturing process that exceeded GPN's timeline requirements

Time and Cost Savings

With a manufacturable vaccine and positive toxicology results, BioCina transferred GPN’s pneumococcal vaccine out of the lab and into clinical trials in just ten months.

SUMMARY

GPN Vaccines brought its life-saving pneumococcal vaccine to clinical trials by working with BioCina. BioCina’s comprehensive process development expertise and high-quality manufacturing solutions were essential for this project. Ultimately, BioCina provided GPN Vaccines with a robust and reproducible manufacturing process and a clinical batch of vaccines in just ten months.

Want more information about this success story? GPN Vaccines was recently featured in Outsourced Pharma. GPN Vaccines Chairman and CEO Tim R. Hirst, Ph.D., shared his side of the story and offered insights for success in a developer/CDMO relationship. Read the article here.

Work With BioCina

BioCina is your partner for high-quality, cost-effective microbial process development and cGMP manufacturing solutions for recombinant proteins and GMP plasmid DNA. Our professional and experienced project management team will guide the efficient development, delivery, and supply of all your contract development and cGMP manufacturing requirements.

To inquire with BioCina about your next project, contact us today.