After more than 20 years of setting the global standard for high-functioning excipients, BioSpectra is challenging the need for atypical active ingredients.
BioSpectra is globally recognised as the industry leader in creating the finest life science intermediates and excipients. Building on its experience as the supplier of choice for the pharmaceutical industry, it launched an initiative in 2011 to create a new standard for manufacturing active pharmaceutical ingredients (APIs). More than four years and $10 million later, that vision was realised in Bangor, Pennsylvania, US – just 130km (80 miles) north of CPhI North America’s 2017 inaugural event in Philadelphia.
Starting with a 150,000ft² building across 35 acres, with parts of the structure more than 200 years old, the team at BioSpectra renovated and retrofitted the historic site to create a world-class API manufacturing facility.
Today, from this renovated facility, BioSpectra offers a new option to managing ‘atypical’ actives: convert these ingredients to ICH Q7-compliant APIs supported by a Type-II Drug Master File (DMF) or Active Substance Master File (ASMF).
BioSpectra’s first conversion of this type was for an ‘atypical’ active that had been discovered to be of deficient design and control during an inspection supporting a drug filing. By manufacturing the product with the appropriate equipment, systems and controls supported by the necessary regulatory documentation, BioSpectra offered it as an API suitable for its intended end use, yielding a recommendation for drug approval. BioSpectra is currently designing two additional APIs for the same customer to be manufactured using its new solvent-based manufacturing system, which is currently under construction.
Harmony and validation
With this successful conversion, BioSpectra designed a programme to meet the needs of other drug-product manufacturers, providing them with cost-effective ingredients designed for their intended end-use in drug applications. BioSpectra designs a process, selects manufacturing equipment, and qualifies the systems, equipment and utilities. Its team works with customers to secure the correct raw materials and qualify the best supply chain. It develops and validates the manufacturing process, harmonises methods and specifications, and develops impurity profiles from raw material through to finished goods.
BioSpectra also defines physical characteristics for the new material, analyses and documents the results of each phase, and develops and completes an appropriate accelerated stability programme. The company builds the DMF or ASMF and submits it to the appropriate regulatory agency, and hosts inspections to review the systems and filings. All of this is done in house and on site in the new API-manufacturing facility in Bangor.
Making the grade
By using long-term supply agreements and guiding its customers to the correct product grade, BioSpectra can make the transition from ‘atypical’ active to true API financially sound. Using its fully documented and traceable processes, BioSpectra offers products manufactured in accordance with ICHQ7 guidelines including Bio Excipient Grade products supported by a Type-IV DMF and Bio Active Grade products or Bio FUISA Grade products (for use in sterile applications) supported by a Type-II DMF or ASMF.
BioSpectra also offers exclusive contract manufacturing opportunities for manufacturers that want a higher compliance version of their own product. Visit the BioSpectra team in May 2017 at CPhI North America at booth #2417.
