Acumen Biopharma Launches New Business Unit, Expands Capabilities Into Continuous Pharmaceutical Manufacturing
The Princeton-based biopharmaceutical consultancy for IP litigators announces the creation of Integra™ Continuous Manufacturing Systems, led by Fernando Muzzio, PhD
PRINCETON, N.J.--(BUSINESS WIRE)--“The launch of a new business unit tremendously expands our capabilities in the analysis, engineering and implementation of continuous pharmaceutical manufacturing,” states Daisy Rivera-Muzzio, RPh, MBA, President and Co-founder of Acumen BioPharma, LLC. “The new unit, Integra™ Continuous Manufacturing Systems, will be headed by Fernando Muzzio, PhD, a renowned leader in the design, evaluation and implementation of continuous manufacturing systems for the pharmaceutical and chemical manufacturing industries.”
“Integra will focus on providing a wide range of consulting services to help companies to select and design products for continuous manufacturing, specify equipment, design, qualify, and optimize processes, implement sensing and control methods, and support regulatory interactions”
“Continuous process is the future of pharmaceutical manufacturing,” explains Muzzio, a distinguished professor at Rutgers University and director of the National Science Foundation Engineering Research Center on Structured Organic Particulate Systems with a special emphasis on continuous manufacturing, particle engineering and personalized medicine. “Integra will focus on providing a wide range of consulting services to help companies to select and design products for continuous manufacturing, specify equipment, design, qualify, and optimize processes, implement sensing and control methods, and support regulatory interactions,” offers Muzzio. “These services will significantly facilitate adoption of continuous manufacturing technologies by pharmaceutical companies.”
Muzzio is in an excellent position to lead the new business unit. A thought leader in continuous manufacturing with 15 years of experience in this area, he maintains consulting relationships with numerous other firms, including 15 of the top 25 pharmaceutical manufacturing companies in both the branded and generic sectors in product and process design and on the use of statistical methodologies to support product and process optimization and regulatory compliance. He also heads a network that provides unmatched academic resources in establishing facts and supporting data regarding pharmaceutical particle technology.
Since its inception in 2012, Acumen BioPharma has developed a world-class network of scientific experts and testing services that it matches with clients in support of intellectual property (IP) and antitrust litigation. This expansion fortifies Acumen’s ability to harness innovations in pharmaceutical formulation and manufacturing research through a greatly enlarged network of academic partners, resolve product and process issues, and improve manufacturing process controls and regulatory compliance.
According to the FDA, Continuous Pharmaceutical Manufacturing, the focus of the new business unit, has many advantages and is rapidly growing in importance both in the US and abroad. In a recently released report on priorities in advanced manufacturing, entitled, “Advanced Manufacturing: A Snapshot of Priority Technology Areas Across the Federal Government,” the Subcommittee for Advanced Manufacturing of The National Science and Technology Council identified continuous pharmaceutical manufacturing as one of five manufacturing technology areas of emerging priority, and mentioned the ERC-SOPS in first place among the "Selected Examples of Federal Investment". The list also includes explicit mention of FDA grants to Muzzio.
About Acumen BioPharma, LLC
Acumen BioPharma, LLC, is a privately held biopharmaceutical consultancy in Princeton, New Jersey. Acumen serves intellectual property attorneys in need of scientific expert witnesses and/or laboratory testing to support patent litigation, those in need of testimony from hands-on industry experts in antitrust cases, and scientists seeking help solving a formulation or manufacturing problem affecting product quality.
With more than 20 years of global experience developing business in the pharmaceutical industry, Daisy Rivera-Muzzio, RPh, MBA, serves as president and managing partner of Acumen BioPharma. Rivera-Muzzio is an expert in evaluating scientific arguments regarding intellectual property, working both with innovator and generic companies in the healthcare industry. In addition to leading Acumen BioPharma, she is Co-Chair of the New Jersey Chapter of Licensing Executives Society (LES), a professional organization for IP professionals that facilitates global IP commerce through education, networking, standards development and certification. Rivera-Muzzio assists those seeking to develop innovative technologies in accelerating commercialization of intellectual property.