GMP—good manufacturing practice—is such a common term in bioprocessing that its precise meaning is becoming clouded. Such ambiguity can create problems across organizations.
Just because multiple parties follow good manufacturing select or good lab) practices doesn’t mean they all follow the same practices. Minute differences can determine whether manufacturers meet existing regulatory requirements or are prepared for likely future requirements. Addressing differences early helps minimize misunderstandings among suppliers and customers regarding their efforts, timelines, and costs on the way to commercialization.
Roche CustomBiotech has seen problems evolve from such discrepancies often enough to know that it and its customers must have a mutual understanding of the details that go into the making of high-quality life sciences products. Achieving transparency with its customers, therefore, is one of Roche CustomBiotech’s distinguishing elements.
“The biggest challenges for the diagnostics and bioprocessing industry is proving that everything goes well from the start and all the way through clinical trials and commercialization,” elaborates Christian Huber, international business leader for Roche CustomBiotech. And the way to meet those challenges is to focus on the details to ensure they each are right. That includes having the ISO 13485 certificate, proving quality by adhering to GMP where applicable, documenting each detail, and demonstrating scalability. “We’re at the top end of what we do and how we share transparency. Having those conversations about GMP, scalability, and a host of other details is part of what sets us apart.”
Driving a paradigm shift
Roche traces its beginnings to 1896, when Fritz Hoffmann-La Roche launched one of the world’s first industrial-scale pharmaceutical companies. As the company grew, it added offices throughout the world and expanded the business to include pharmaceuticals, vitamins and fine chemicals, diagnostics, and flavors and fragrances. Nearly 100 hundred years later, the company returned to its original focus: pharmaceuticals and diagnostics. At about that time, in the 1980s, Roche CustomBiotech was formed.
“The purpose, originally, was to sell select products and solutions into the diagnostics and biopharmaceutical markets. We saw a chance to increase sales and use excess manufacturing capacity. It became clear, however, that we could do more than sell off the shelf. Then custom projects came into the picture,” Huber says. Product variations morphed into opportunities for co-development that leveraged Roche’s R&D and operations skills. Gradually, those opportunities led to the adaptation of in vitro diagnostics instruments and assays for metabolite testing and bioprocess monitoring, as well as technology platforms for the diagnostic side of the business.
Biotherapeutics and diagnostics each have strong growth potential, he says, citing the steady expansion of molecular and sequencing options to shed light on disease, and physicians’ growing reliance on companion diagnostics, as well as the use of big data analytics to match the right drugs to the right patients for clinical trials for increasingly personalized medicine.
Roche CustomBiotech’s stated mission is, according to Huber, “to enable the healthcare industry to develop and produce state-of-the-art solutions for diagnosis and treatment. We do that by providing reliable, tailor-made, high-quality products and technologies.” To that end, the company provides raw materials, instrumentation, products, and services for drug development, production, cell therapy, and in vitro diagnostics for its clients, customized to clients’ specifications.
mRNA interest grows
CustomBiotech is particularly interested in providing enzymes for mRNA therapeutics—both as cancer vaccines and drugs. This relatively new therapeutic option offers an attractive alternative to traditional therapies and, although only a relatively few clinical trials are underway globally, seems to suggest increased efficacy.
As to the potential value for therapeutic mRNA, Huber points to Moderna Therapeutics’ IPO on December 6, which raised $604 million in what is widely touted as the largest-ever U.S. biotech IPO.
“We want to be a leading supplier for therapeutic mRNA manufacturers,” Huber says. CustomBiotech’s mRNA enzyme portfolio has grown steadily during the past 18 months, including the T7 RNA polymerase as the main enzyme. A new RNAse inhibitor will be launched next year, and “we’re continuing to develop new enzymes to complement our portfolio. Therapeutic mRNA regulations are evolving and may require higher quality levels in the future,” he points out.
The bioprocess monitoring business also is seeing increased investment from the company in the form of a range of in-process control testing. “We also will expand and build on our bioprocess monitoring with our Cedex line of metabolite and cell analyzers,” Huber says. Currently, this product line includes the Cedex Bio HT Analyzer, Cedex Bio Analyzer, and the Cedex HiRes Analyzer. These may be integrated into the cell fermentation process.
On the diagnostics side, CustomBiotech is also expanding its range of molecular diagnostics with novel engineered polymerases, such as KAPA 2G and KAPA 3G. The benefit, Huber explains, is that “these second- and third-generation enzymes allow for a faster and more inhibitor resistant amplification reaction, generating fast and highly valid test results from crude prepared samples.”
Customization and scalability
Roche CustomBiotech is known for its customization and for the scalability of its solutions. “We’ve developed more than 150 custom solutions including many co-developments in the past 10 years,” Huber points out. “We have shared histories with a number of companies that have become market leaders, and we have grown with them.”
Such successes for Roche and its customers imply a plenitude of discussions with organizations at the forefront of their fields. Their purpose is to understand innovators’ goals, more immediate needs, and, of course, how Roche CustomBiotech can help. Those continual communications, leveraging Roche CustomBiotech’s expertise, in-depth market research, and attendance at industry events all contribute to this ability, showing that thoughtful conversations really can catalyze innovation.
Location: Roche Diagnostics GmbH, Am Nonnenwald 2, 82377 Penzberg, Germany
Phone: +49 89 8856-0
Principal: Thomas Schinecker, Global Head of Centralized and Point-of-Care Solutions, Roche Diagnostics
Number of Employees: 120
Focus: Roche CustomBiotech develops industrial-scale solutions for the biopharma and diagnostics industry, ranging from raw ingredients through systems solutions for bioprocessing.