Pharmaceutical Grade Chemicals – And More
The quality of the chemical ingredients, APIs and excipients that make up a pharmaceutical product is of primary importance to the overall success of any pharmaceutical drug.
Many companies can supply a pharmaceutical chemical, but how many have the experience, the expertise and the quality to ensure that your products always meet your quality standards, FDA regulations, and the demands of healthcare consumers?
Spectrum Chemical Mfg. Corp., headquartered in New Brunswick, New Jersey has been the go-to supplier of chemicals for not only pharmaceutical research, development and manufacturing but also for a number of other markets including pharmacy compounding, personal care and cosmetics, and food and beverage, since 1971.
In 2015, the company formed a new division, Spectrum Pharmacy Products, and recently launched the Spectrum Pharmacy Institute which offers a comprehensive, lecture-based and hands-on continuing education for pharmaceutical compounding.
In the Beginning
Spectrum was founded in 1971 by Paul Burg, who remains Chairman of the company. The original company housed only a few thousand square feet for manufacturing, distribution and business offices and supplied a relatively small catalog of products. After more than five years of business growth and catalog expansion, the company officially changed its name to Spectrum Mfg. Corp., a name meant to convey the broad range of fine chemicals they could provide to quality-driven industries.
Today, Spectrum continues to offer one of the largest catalogs of fine chemicals in the industry. Randy Burg, current CEO and son of Founder Paul Burg, explained, “We carry over 45,000 chemicals, including the largest offering of 1200 USP-NF-FCC items in a range of product sizes. Our portfolio of superior products is sold by large distributors such as VWR and Grainger, providing a broader reach for us in the pharma industry.”
Burg continues, “Even in the personal care and cosmetics industry, companies are moving toward these pharmaceutical grade, monograph-type raw materials because their customers are demanding higher-quality and safer ingredients.”
Nearly five decades later, today Spectrum also distributes more than 200,000 equipment and supply items. As Burg says, this diversity of products truly makes the company a one-stop-shop for a wide range of industries.
At the Core
Whether sourcing products or manufacturing its own chemicals and solutions, Spectrum is dedicated to rigorous in-house testing to ensure the highest quality ingredients.
“It’s one thing to say you are focused on quality. It’s entirely different to invest in the facilities, personnel and systems required to ensure that you fulfill this customer promise,” says Burg. “Balancing that financial commitment with competitive pricing is what’s really important to our customers.”
Spectrum tests all raw materials and provides the crucial documentation and transparency needed as a pharma company moves from R&D to pilot, scale up and production.
One of the few companies of its size to remain family-owned and privately held, Spectrum maintains strong customer relationships and service while expanding its footprint across many industries. “I tell my employees: You want to make me happy? Make our customers happy,” says Burg. “We have found our niche in staying close to the customer, while so many companies lose this focus as they grow. It’s our vision to maintain and strengthen the family-owned persona my father started nearly five decades ago, with both our customers and our employees.”
Economies of Scale
Spectrum’s customers are involved in a wide range of laboratory research, product manufacturing and patient care activities. The amount of chemicals needed for these segments varies widely. Spectrum is able to provide research quantities for many products otherwise offered only in bulk quantities. The company recently announced a new line of BASF precious-metal-containing powder catalysts in small sizes ranging from 1 g to 100 g. These catalysts are often used in organic synthesis and medicinal chemistry. The new agreement with BASF combines Spectrum’s broad customer reach with BASF’s leadership in catalysts, providing pharma companies access to this chemistry in the smaller quantities needed for early product development. Spectrum’s company motto From Bottles to Bulk rings true with pharma companies as they move from R&D to production.
Documentation is Key
Regulation of the pharmaceutical industry is both far-reaching and continually expanding. Thorough scientific documentation of raw materials is critical in eliminating down time as a pharma company submits a new drug application (NDA) and scales up from Pilot to Production. When a company does not consider this in early development and later must chase down a certificate of analysis or manufacturing process flowchart for a raw material, significant time and money can be lost. It is important to work with a partner like Spectrum Chemical that offers not only a broad range of high quality products, but also the regulatory documentation to support them.
Burg explains, “When you buy a chemical from Spectrum, you are not just purchasing the product, you’re also getting the documentation to support it as well. We put our scientific dossiers right on the website, so customers don’t have to chase down the information. Our bicoastal cGMP facilities in New Jersey and California are routinely audited, so we simply make this scientific documentation available to our customers.”
Compounded Interest
Personalized medicine has driven expansive growth in pharmaceutical compounding, where therapeutics are customized for an individual patient’s precise requirements. From pharmacies to university medical centers and hospitals, physicians and pharmacists are working together to provide personalized, compounded drugs for many reasons including patient allergies, drug resistances to commercial medications, drug shortages and an aging population. A patient may require a drug that is formulated not to trigger allergies, or one that is commercially unavailable at the needed strength. Patients are relying on quality, safe compounded medications prepared by trained compounding pharmacists.
Craig A. Recatto, PhD, President of Spectrum Pharmacy Products, explains how Spectrum became involved in compounding, “We recognized the need back in the early ‘70s and were one of the first companies to provide our US pharmaceutical grade products to compounding pharmacies. Today, the high-quality ingredients are still needed, but compounding training is needed even more.”
Despite the recent resurgence in compounding, the science and art of compounding is not being taught in the pharmacy schools. To meet the growing demand for compounded medications, Spectrum’s recently launched Spectrum Pharmacy Institute offers accredited compounding training for pharmacists and pharmacy technicians on a range of topics not taught in pharmacy school. The new, $11 million state-of-the-art facility in New Brunswick, New Jersey offers the latest best practices and hands-on compounding training to pharmacists nationwide.
Spectrum Pharmacy Institute currently provides accredited continuing education programs on topics ranging from basic compounding to sterile compounding, hazardous drug handling (USP<800> compliance), pain management, and hormone replacement therapy. Future classes such as veterinary compounding are currently under development. The on-site compounding courses are taught by national experts and are jointly accredited with the Ernest Mario School of Pharmacy at Rutgers University or the American College of Apothecaries. Additional accredited online courses are also available through the company’s website at SpectrumPharmacyInstitute.com.
Recatto explains that due to the Drug Quality Safety Act, compounding pharmacies were split into two groups. Those that only compound according to a prescription specific to a particular patient were put in the 503A section of the act. Pharmacies that manufacture large batches with or without prescriptions (such as injectables) were given their own 503B classification, technically called “outsourcing facilities.”
“This provides an opportunity to set Spectrum apart,” says Recatto. “The 503B entities must operate under cGMP compliance, but they’re still technically a pharmacy, regulated under the pharmacy section of the Food Drug and Cosmetic Act. These 503B’s are essentially boutique pharma companies, and there are only a handful of suppliers of APIs and excipients to that specific market. Spectrum stands out as a leader due to our decades of experience in the cGMP environment supporting traditional pharma companies. We are educating pharmacists on compounding and also on cGMP – something else that is not being taught in school.”
Looking Ahead
As Spectrum looks ahead to the future, CEO Randy Burg explains how the company will remain focused on what it does best while expanding into other markets.
“You’d be hard-pressed to find another chemical manufacturer with such a large catalog of pharmaceutical grade products under one roof. The fact that we offer such a broad range of these products with thorough, consistent documentation and traceability is what makes us unique,” Burg concluded. “We will continue to work with other markets such as biopharmaceuticals, cosmetics, and food and beverage. Companies in these segments are well aware that the products they manufacture are coming under more scrutiny by regulatory agencies. It is in their best interest to use ingredients that are USP grade, tested, documented and traceable.”