Investing in Technologies
In addition to offering process development services, many CMOs are investing in new processes and technologies as well as ramping up capacity to meet industry needs. Avecia Biologics’ (www.avecia.com) pAVEway™ technology for the manufacture of therapeutic proteins is an example.
“Our newly launched pAVEway technology platform is attracting interest at the preclinical stage, as some clients value a process that is largely defined at an early stage without the need for considerable rework as the project progresses,” comments Kevin Cox, president and managing director of Avecia. pAVEway is expected to provide the client with improved expression levels, increased flexibility, and lower costs.
Similarly, BioInvent (www.bioinvent.com) strengthened it’s large-scale cGMP disposable manufacturing approach for mAbs through the acquisition of a Wave System 1000 (Wave Biotech, LLC, now part of GE Healthcare; www.wavebiotech.com).
“After a one year thorough evaluation of the smaller Wave 20/50, BioInvent decided to invest in the largest Wave System 200/1000 line,” says Dan Andersson, senior business development director.
Pointing to another advantage with using disposables and meeting time lines, Andersson notes, “It took us only nine months from specification and ordering to starting up regular cGMP manufacturing.” This is less then 50% of needed installation time for stainless steel tanks, he adds. “One key factor behind this rapid time line is the minimum need of qualification and cleaning validation.”
Goodwin Biotechnology “increased its capacity to 500 L stir tanks, tripled process development capacity, and added upstream development,” explains Stephanie C. Finnegan, CEO. In addition to the capacity expansions and greater resources devoted to process development in meeting its clients’ needs, Finnegan explains that Goodwin has also “solidified a partner for molecular biology, developed proprietary purification techniques, and hired talented individuals with Phase III/commercial experience.”
In addition to building a process development lab in India, the company plans to offer manufacturing services for commercial production in both the U.S. and India. “This has required significant capital investment provided by our parent company,” Finnegan concludes.
Boehringer Ingelheim (www.boehringer-ingelheim.com) follows the one-stop-shop concept with a list of clients that range from small research-based operations to large pharmaceuticals.
“All elements required for outsourcing biopharmaceutical development and production, from high expression system to fill-and-finish, can be found within the corporate capabilities of Boehringer Ingelheim,” states Rolf G. Werner, corporate senior vp, biopharmaceuticals.
“We constantly improve our development and production processes and we continuously invest in our facilities. The current capacity adds up to 180,000 L for mammalian cell culture processes and 12,000 L for microbial processes. Our partners know that they can rely on us to respond to their needs by creating flexible and integrated biopharmaceutical solutions, which minimize their initial investment risk.”
Laureate Pharma (www.laureatepharma.com) is working with Boehringer Ingelheim to offer full service capabilities from small-scale to commercial production. “We have entered into a preferred partnership agreement with Boehringer Ingelheim to provide our clients with a complete path from clinical-scale production at Laureate to large-scale commercial manufacturing at Boehringer Ingelheim.” states Mike Cavanaugh, vp of sales, marketing, and business development at Laureate.
In addition to working with Boehringer Ingelheim, “We have added a new pilot plant to Laureate’s manufacturing facility for early engineering runs and producing product for uses such as formulation and toxicological testing. The equipment in our pilot plant facility is designed to facilitate a direct, seamless scale-up from development to cGMP production for our clients’ projects.
“With the new pilot plant in operation, we can accelerate our manufacturing of preclinical material and save on several months’ worth of product development time, which is critical to our clients.”