Sigma-Aldrich Corporation: Setting the Benchmark for Scalable Bio and Chemical Products

CIO VendorRakesh Sachdev, CEO, Sigma-Aldrich Corporation From large ecosystems to nano particles, recent leaps in the field of biotechnology are leading to potential solutions that can alleviate many global challenges. Though biotechnology has created amazing possibilities, there is still an increasing demand from companies for extensive laboratory support and services, hi-tech products and pharmaceutical components. In addition, affordability is arguably one of the major issues across the industry. Ethical concerns also will play a major role in the future of expensive biotech services. With deep-rooted expertise in life science technologies, Sigma-Aldrich Corporation, a Life Science and High Technology company, serves the biotech platform with their affordable range of hi-tech biochemical, organic chemical products, kits and services, which are used in scientific research. Their key components can be implemented in pharmaceutical, diagnostics, and manufacturing to maximize life sciences research. “As a global leader in life science, we offer a variety of products for molecular biology, protein expression and Proterozoic, cell biology, functional genomics, and transgenic components,” says Rakesh Sachdev, CEO, Sigma-Aldrich Corporation.

Sigma-Aldrich Life Science—Extensive Products and Tools

Sachdev, a staunch proponent of life science research and development, brought about a transformation in the arena. His expertise in the most common methods used in biochemistry and molecular biology has enabled Sigma-Aldrich to be one of the major suppliers of custom and predesigned nucleic acid products, peptides and molecular biology tools. Sigma-Aldrich Life Science, a segment that represents the company's leadership in innovative biological products and services—also offers an array of biologically-rich products and reagents that researchers use in scientific investigation. Product areas include biomolecules, genomics and functional genomics, cells and cell-based assays, transgenics, protein assays, stem cell research, epigenetics and custom services/oligonucleotides. Further, the company provides an extensive range critical bio essentials like biochemicals, antibiotics, buffers, carbohydrates, enzymes, forensic tools, hematology and histology, nucleotides, amino acids and their derivatives, and cell culture media.

“Our ability to guarantee quality and performance is directly related to our comprehensive understanding of various synthesis chemistries and manufacturing platforms, investment in analytical systems, and the experience in methods development,” claims Sachdev. Sigma-Aldrich owns many analytical tools that can be leveraged to refine early stages of various products and processes. From fully characterizing the stereo-isomerism of molecules to advanced cell line optimization, “we have a full suite available for our customers to tap into. We can even help make the screening easier by custom weighing and packaging compounds,” he adds. Finally, when the time comes to actually scale up a molecule and optimize its yield prior to clinical testing, Sigma-Aldrich introduces SAFC Pharma.

SAFC Process Development and Regulatory Compliance

The custom manufacturing and services business unit of Sigma- Aldrich, SAFC stays on the edge of science, technology and manufacturing. SAFC
employs a proactive and visionary approach in providing customized solutions that span the entire product development pipeline. Once a development candidate has been identified, SAFC can rapidly develop processes and supply the necessary quantities of product required to efficiently support pre-clinical studies and advance lead programs in the shortest possible timeframe.

For over 25 years, SAFC has effectively and safely been delivering large-scale products to the commercial life sciences industry. “Our clients can expect high-quality, scalable, and reproducible chemical and biological products, along with the confidence that comes with decades of experience in manufacturing small and large molecules according to country-specific regulatory standards,” says Sachdev. Being the developer and manufacturer of critical raw materials, SAFC ensures process performance, regulatory compliance and business security. In fact, they can make it easier to improve workplace safety, ensuring that companies are operating at the top of current standards.

The Biological Manufacturing Toolkit—CHOZN Platform
On the biological manufacturing front, CHOZN, Sigma- Aldrich’s royalty-free biological manufacturing toolkit, enables their customers to increase the speed of getting a biopharmaceutical to the market, while reducing the manufacturing cost. The CHOZN Platform was developed to provide an off the shelf production solution to biopharmaceutical developers who don’t currently have a cell line platform. Chinese Hamster Ovary (CHO) cell lines continue to be the predominant cell line of choice for biopharmaceutical manufacturers. SAFC’s CHOZN products and services are created, utilizing CompoZr Zinc Finger Nuclease (ZFN) technology to engineer CHO cell lines with characteristics that are attractive to biopharmaceutical developers and manufacturers, including stability, time, ease-of-use, and adaptability. The CHOZN Platform consists of the CHOZN GS-/-CHO cell line, and an optimized set of cGMP-produced, chemically-defined media and feeds that have been designed with the cell line to maximize production of r-proteins. The Platform system has been designed and tested to perform initial cell line engineering process and stable cell line selection through large scale growth and production.

Sigma-Aldrich's Analytical Microbiology products include growth media, ingredients, supplements, and reagents for identification, discs, strips and test kits for general microbiology and food and environmental analysis. “We provide signaling compounds for quorum sensing and selective media for detection of pathogenic mold and bacteria, media for molecular biology, fluorescent and chromogenic media, media-free of animal-derived ingredients and instructions on media selection and preparation,” explains Sachdev.

SAFC’s Antibody-drug Conjugation Technology
With more than 30 years of experience in bio-conjugation, Sigma-Aldrich has become a leading expert for the conjugation of highly active molecules. Antibody-drug conjugation technology (ACDs) uses monoclonal antibodies or other biologics to deliver conjugated Highly-Active Pharmaceutical Ingredients (HAPIs) to targeted cells. In conjugated form, the HAPI exhibits more selective cytotoxicity, thereby, sparing non-target cells from many of the toxic effects. Customers are quickly adapting these complex technologies and employing them to develop new oncology products that are more targeted and exponentially more powerful. “We offer development and manufacture of commercial scale HAPIs, linkers, cytotoxic agents and conjugates. We also provide extensive analytical tests for APIs and biological assays and a combined approach for ADC to simplify the supply chain,” he says. SAFC offers a unique
product and service solution for customers looking to take their conjugate therapeutics from clinical phases into commercialization. Apart from serving industries in academic research, biopharmaceuticals, and clinical diagnostics, Sigma-Aldrich helps in forensic testing, specialty chemical, and pharma research. The company combines world-class, "single point of contact" for project management with proven processes and procedures and offers analytical and process development support at all stages of drug development and manufacture. “From pre-clinical through commercialization, we enable customers to bring their products to market in the most efficient timeframe possible,” affirms Sachdev.

For instance, Baxter BioPharma Solutions—a business unit of the American health care company, Baxter, that provides scientific expertise, sterile contract manufacturing solutions, parenteral delivery systems, and customized support services for pharmaceutical companies—along with SAFC, created a seamless contract manufacturing environment that supports customers, to navigate the complex challenges of ADC development. The bulk drug substance conjugated by SAFC will be directly transferred to Baxter’s project management team using established protocols. The Baxter team will then work to ensure that the correct filling, regulatory testing and validation, packaging, and import/export paperwork is processed and the product lot is approved for distribution.

Furthermore, Sigma-Aldrich owns a single-partner, customized sourcing program—CHESS Program designed specifically to fit the client needs. CHESS allows quick identification and ordering of materials through a flexible, global network of suppliers. Working with CHESS also eliminates the need to add new vendors. Along with procurement and sourcing services, “SAFC CHESS fully supports the business goals of our customers, corporation, and the Federal Government to provide the opportunity to compete for the procurement of goods and services,” he adds.
Possessing more than 200,000 products and 500+ services, Sigma-Aldrich has always been the supplier of choice for a broad range of community.

With the recent acquisition by Merck—a leading company for innovative and top-quality high-tech products in the pharmaceutical, chemical and life science sectors—Sigma-Aldrich experienced a ‘quantum leap’ and enhanced its position in the global life science industry. “The acquisition marked a milestone on our transformation journey aimed at turning our businesses into sustainable growth platforms,” said Karl-Ludwig Kley, Chairman of Merck’s Executive Board. “The combined company will be well-positioned to deliver significant customer benefits, including a broader, complementary range of products and capabilities, greater investment in breakthrough innovations, enhanced customer service, and a leading e-commerce and distribution platform in the industry,” concludes Sachdev.

From pre-clinical through commercialization, we enable customers to bring their products to market in the most efficient timeframe possible

Sigma-Aldrich Corporation

Rakesh Sachdev, CEO, Sigma-Aldrich Corporation

We offer a variety of products for molecular biology, protein expression and Proterozoic, cell biology, functional genomics, and transgenic components