Digitalization in microbiology has heralded several discoveries in the areas of traditional pharma, biopharma, and life sciences. Fueling profound research work into the drug development landscape for decades, the modern-day pharma and biopharma technologies have progressed tremendously while influencing the very evolution of global healthcare.
However, even with all the innovation and technologies at their disposal, today’s pharma/biopharma research world still endure a multitude of age-old complexities that lie unmitigated. These complexities directly impede the development of new drugs and approaches for the treatment of diseases. Consequently, the cure for several diseases like cancer, dementia, and inflammatory disorders have remained elusive despite decades of research, while patients still lack access to affordable and safe medicine.
Observing and studying these concerns closely for years, pharma and biopharma industry experts have narrowed down the pain points to the inherent challenges in improving patient outcomes amid intensifying competition among pharma companies, and the ever-increasing pricing pressure while maintaining the quality of drug research and discovery. Compounding these issues are the technical complexities in quality control and drug testing, traceability of product quality, incomplete or erroneous record keeping, and regulatory pressure. Against this backdrop, Sartorius Group stands tall as a reliable partner of the pharma/biopharmaceutical industry and the research sector, offering technology and quality control solutions for the development of drugs that can change and improve people’s lives. Ki Nagashima, Manager of product specialist at Sartorius Japan, says, “We are enabling biotech scientists and engineers across the globe to seamlessly develop and manufacture quality medications, right from conceptualization to production with a goal to empower more people with access to better medicine.”
Sartorius equips its clients with a vast range of pharma quality control solutions that ensure accuracy and facilitates seamless lab operations for modern researchers. Being an industry pioneer, Sartorius is focused on developing innovative technologies that simplify the complicated and expensive bio-pharmaceutical procedures. The company provides clarification of media additives, buffers, chemical reagents, drugs, and gases for extensive pharma/biopharma research projects. As a go-to solution provider for a multitude of biomedicine researchers globally, Sartorius brings to its clients the expertise of more than 8,000 staff members spread across 110 different countries.
Exceptional Product Portfolio: From Premium Lab Balances to Microbiological Testing Kits
Sartorius holds a distinct reputation for manufacturing high-quality equipment and consumables for the pharma QC workspace. The company’s proprietary product range includes balances, filters, pipettes, ultrapure water systems, and microbiological testing kits that are used extensively in the field of pharma research. “There is an increasing need for pure high-value compounds to be used as pharmaceuticals, especially in the drug development phase. Sartorius is focused on accuracy, reproducibility and compliance throughout the drug development process with a wide range of products and professional services,” adds Sagarika Adiraju, senior application specialist at Sartorius India.
We are enabling biotech scientists and engineers across the globe to seamlessly develop and manufacture quality medications
Biopharma organizations that either use cell cultures to manufacture products, or produce cells for cell-therapy products, face additional challenges as they must show their products are free from Mycoplasma contamination. The conventional culture-based testing for Mycoplasma takes 28 days, and the product cannot be released until the test results are available. Traditional sterility testing is also not feasible on cell therapy products due to their short shelf-life (2-4 days) and the 14 day time period required for a traditional sterility test. “Our rapid, real-time PCR kits are designed to perform this testing reliably within hours, enabling the confident and rapid release of these products,” states Glenn Manning PhD., application specialist at Sartorius Australia.
Redefining Lab Dynamics
Lab operations in pharma and biopharma research are highly complex and demanding in nature. It is often observed that despite repetitive analytics routines, the staff is required to be extremely cautious during each step of the research project to obtain reliable and accurate results. The engineers and specialists at Sartorius ensure that their customers in pharma research maintain the quality of their work by providing them with pharma QC products designed to minimize operator fatigue, simplify the workflows, and reduce physical workloads to a minimum. Sartorius application specialists say, “We strive to support our clients with sample preparation, expression system selection, lab to pilot plant, process validation, and process optimization until their end-product is out into the market.”
Over several years of developing and perfecting the laboratory operations at Sartorius, “continuous air monitoring” has stood out as one of the complex and key topics in the fields of pharma QC. Initially, it was observed that it was impossible to collect the air for more than a few hours using conventional air samplers. Sartorius’ gelatin membrane filter method proved to be the perfect solution for continuous air monitoring. The gelatin filter method enabled their pharma customers to collect the air for several hours without losing the proliferability of microorganisms. Following this development, the auditors of a regulatory body requested to conduct continuous air monitoring to confirm the cleanliness inside the isolator. In response to this, several pharma and biopharma customers began to use the gelatin membrane filter with MD8 airscan®
as their continuous air monitoring procedure. The regulators found that the continuous air monitoring conducted by the Sartorius’ gelatin membrane filter method not only effectively performed the job but also readily complied with all the unique specifications and the requirements of the authority.
Pharma QC customers also use Sartorius’ arium water systems for purified water (type 2 or 3) for cleaning and rinsing, and ultrapure water (type 1) for producing reagents for analytical analyses. The company has provided laboratory water systems to a multitude of pharma QC labs and has supplied them ultrapure water for performing analyses for testing products. “We have also provided manufacturing laboratories with endotoxin-free, ultrapure water for use in their R&D manufacturing process. Our sterility test systems are used by a number of pharma QC labs to confirm the sterility of their products,” affirms Manning.
"Sartorius is focused on accuracy, reproducibility and compliance throughout the drug development process with a wide range of products and professional service"
A Strong Regulatory Stature to Support Customers Meet 21 CFR Part 11 Compliance
Given that the modern pharma industry is governed by the stringent regulations of USFDA and other regulatory bodies, Sartorius enables its customers to stay ahead of the regulatory constraints. The company offers a complete solution in pharma QC, where the customers can avail all the products and information they need to conduct their daily QC tasks while staying within the boundaries of regulatory and compliance norms. Regulations such as GxP and CFR have always been a significant hurdle in the process of drug development. To address this from the product point of view, Sartorius brings Cubis II for its customers, as an ideal solution for achieving data integrity required by CFR 21 part 11 regulation. Cubis II is a standalone platform that enables the pharma QC customer to adapt to regulations without requiring any middleware. With the help of direct PC communication and Pharma Q-App Package, Sartorius provides features such as easy record management, electronic signatures, and data backup to ensure its customers that all ALCOA principles are met as part of everyday balance operation. “From an information perspective, Sartorius has always supported its customers by offering the latest regulatory information,” says Danielle Aridis-Lang, applications specialist atSartorius Australia. “Our team actively works with regulatory bodies, which provides us with an important market edge as we can use the information for better product development,” adds Aridis-Lang.
Over the years, Sartorius has evolved to become a significant player in the global drug discovery community. The company accredits its prowess to its vastly experienced staff and its distinct work environment that fosters a collaborative atmosphere. “Strengthened by the strong roots and tenets, our corporate culture is shaped by the core values of sustainability and openness that unite our employees across all generations and continents,” concludes Aridis-Lang.