Issue:October 2014

EXECUTIVE INTERVIEW - BioSpectra: Trusted & Reliabe Source for Intermediates

Headquartered in Bangor, Pennsylvania, BioSpectra has a recognized company vision to provide the most trusted and reliable source for life science intermediates. Launched in 1994, the company has grown from developing and manufacturing the first-ever Quality System Compliant versions of key biological buffers, to now also providing Zwitterionic Buffers, Carbohydrates, Excipients, Active Pharmaceutical Ingredients, and starting in Q4, Amino Acids. Offering custom solution versions of every product it makes, BioSpectra values the Quality Partnerships it forms with customers to identify and exceed expectations and requirements. Richard Mutchler, President of BioSpectra, recently spoke with Drug Development & Delivery about the company’s unique ability to provide customers with validated, secure, and traceable intermediates that remain affordable.

Q: For our readers who may be unfamiliar, can you provide some company background and history on BioSpectra?

A: BioSpectra was founded in 1994 with a goal to develop and manufacture the first-ever Quality System Compliant versions of key biological buffers. Following more than 300 Research and Development-scale production batches performed in our original lab in Shawnee-on-Delaware, PA, we opened a 10,000-sq-ft manufacturing facility in Sciota, PA, in 1996. During our early years, preference for the quality-system-based versions of our core products was slow to develop. However, many companies valued the exceptional consistency and purity of our materials, which were at that time, unique characteristics for those batch sizes of 200 to 500 kg. As more companies came to visit our facility, the growing interest in Quality System Compliance as the basis for our product consistency and purity became the foundation of BioSpectra’s reputation. With our eyes focused on quality, we continued to manufacture Urea, Guanidine HCl, Tris, and Tris HCl through 2002 at the Sciota, PA, facility. With the exception of direct sales to key European drug manufacturing customers, our chemicals were sold exclusively through one distributor from 2001 through 2011. During that time period, BioSpectra moved to a larger 20,000-sq-ft facility located in Stroudsburg, PA. This larger facility allowed us to advance our quality platform. BioSpectra was able to design, install, validate, and manufacture exceptionally pure and compliant biological buffers and buffer solutions with its industry-leading, dedicated process suites for each product. Scale of production also improved to allow crystal batch sizes from 3,000 kg to 24,000 kg and solution batches of 50 L to 20,000 L.

In 2011, the exclusive distribution agreement was mutually discontinued, and BioSpectra branded chemicals became widely available to the remainder of our industry. Today, BioSpectra’s in-house, contract manufacturing capabilities provide proprietary versions of its materials exclusively to many customers. Since 2011, our quality focus has expanded to the achievement of yet higher compliance versions of our products directly by their design, validation, and manufacture to specifically satisfy end-drug use requirements. In 2012, we purchased an additional 150,000-sq-ft facility in Bangor, PA, to support our Quality expansion to include full ICH Q7 compliance for our two newest grade offerings, Bio Excipient Grade and Bio Active Grade.

Q: What products and services does BioSpectra specialize in?

A: BioSpectra manufactures Biological Buffers, Zwitterionic Buffers, Carbohydrates, Excipients, Active Pharmaceutical Ingredients (APIs), and starting in Q4 2014, Amino Acids. Custom solution versions of every product are available as well. Excipient and API versions of our core products and contract manufactured intermediates are offered upon request. BioSpectra forms Quality Partnerships with its customers through which their expectations, needs, and end-use application are defined. Written documentation of a mutually agreed upon set of compliance standards is established to successfully guide the relationship. We offer Drug Master File access for Excipient and API partners who require that additional regulatory support. To achieve and maintain the “BioSpectra level of quality” for all of its offerings, we manage our raw material supply chain. We determine the appropriate quality attributes with the customer and perform impurity risk analyses to ensure the continued suitability of the raw materials we use in our processes. We develop a manufacturing process, validate and manufacture the material, and conclude with our in-house accelerated stability program. Additionally, BioSpectra offers a full range of particle manipulation services that includes Jet Milling and Blending performed using Q7-Compliant suites and systems.

Q: What value does BioSpectra bring to its clients? How are you different from your competitors?

A: BioSpectra has, without exception, the best designed and most compliant processes to manufacture life science intermediates. While we perhaps have the newest and largest facility in existence dedicated to these product lines, BioSpectra sets itself apart from other suppliers with the internal work culture of its employees. They are a devoted team of individuals who are committed to providing the highest quality products and services to the chemical industry and to achieving each customer’s total satisfaction. BioSpectra’s state-of-the-art QC Laboratory is equipped to offer safe, validated, secure, and traceable intermediates for use to protect our customers’ end chemistry – all at cost-effective prices. Furthermore, we declare the end-use suitability of our chemicals on each certificate of analysis. Our direct quality relationships provide the best access and support for all regulatory and quality issues. Throughout the BioSpectra experience, our Customer Service Specialists provide attention to each customer’s order processing and delivery instructions, ensuring requested product specifications, coding, and packaging requirements are met to support the timely resolution of all questions and concerns.

Q: How do you overcome the association between quality and affordability?

A: Chemicals manufactured by BioSpectra and sold directly or through our approved channel partners provide quality at the best value available. We offer US-manufactured, safe and compliant Excipients at lower prices than those of our competitors’ off-shore manufactured or repackaged and “spot-tested” versions of the same materials. Because Quality is the primary requisite for all of BioSpectra’s business operations and end products, the economies of scale and benefits of product consistency result in our competitive price advantage. True cost of ownership for our US-produced materials is almost always the best value financially as well.

Q: Can you tell our readers more about your newest facility?

A: The new 34-acre/150,000-sq-ft facility in Bangor, PA, is dedicated to biopharmaceutical and life science intermediates, Excipients and APIs. The facility follows ICH Q7 in its design and operations. While the facility has buildings that were built as far back as the 1700s, it is nearing completion of a total renovation, making it all new. The structure lends itself to exceptional security and stability. We have controlled storage and warehousing areas and fully independent and controlled packaging, manufacturing, particle manipulation, laboratory, and utilities in designated zones throughout our facility. In addition to our several fluid-bed dryers and custom drying systems, we have also added rotary vacuum-drying and spray-drying in this facility. Our first operational zone has five qualified manufacturing suites, each ready to manufacture any of our core products or customer-custom products. Our on-site accelerated stability and real-time stability programs also ensure the delivery of material to meet your schedule.

Q: How has manufacturing for the biopharmaceutical and pharmaceutical industries evolved in recent years? How do you keep pace?

A: BioSpectra has set the pace for quality-based manufacturing of life science intermediates since the first day it opened. Our list of “firsts” is long, but we do not focus on them. We are always focused on the next opportunity to improve end dose safety and security. Clearly, the industry is finally evolving and recognizing the need to allow excipient and intermediate manufacturers the opportunity to assume the responsibility for what they sell. It is time for each manufacturer or seller of ingredients to our industry to declare the intended end use for the products he sells, to document the basis for those assurances, and to remove that responsibility from the drug manufacturers. It is time to stop asking pharma manufacturers to make drugs from chemicals that are labeled as “not for use in drug products.” Further, it is time to practice this responsibility at the correct, reasonable, and value added price-point.

Q: What are the next critical steps for BioSpectra?

A: We have a long list of upcoming Amino Acids, Carbohydrates, and other new products that we will offer in versions ranging from existing market purities to higher compliance, traceable, and validated ICH Q7 versions as Excipients and APIs. We are quickly expanding our custom solution capabilities and are planning a media prep site for 2015. Our operational focus will also include a program to evaluate fully US synthesized versions of key Life Science intermediates, Excipients, and APIs currently available only from manufacturers or suppliers that do not offer fully ICH Q7 compliance with written support, documentation, and regulatory support. We have four products in that pipeline for US synthesis in 2015, and we are looking for new additions. We are fortunate to have a great team, the best facilities, lots of room to grow, and strong relationships with the finest drug manufacturers in the world. In short, we will go where they direct us, and it will be BioSpectra’s privilege to serve them.

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