The Silicon Review
Stem cells hold the potential for manifold applications in biotechnology-based next-generation therapeutics. Scientists are trying to formulate better and more personalized treatment modalities against some seemingly irremediable diseases, by harnessing body’s own stem cells and stem cell niche. Advancement of fundamental research techniques like tissue biomechanics along with continuous emergence of cutting-edge technologies like 3-D printing, microfluidic-platforms etc. lead to a flood of stem cell-based applications in clinical practice. The pros and cons of stem cell therapy in routine healthcare practices must be critically appreciated in order to fetch its benefits to the mankind.
Akron Bio is one such innovative biotechnology company focused on manufacturing high quality products for advanced therapies. It is a leading materials manufacturer and services provider to the regenerative medicine industry, accelerating the development and commercialization of advanced therapies. Akron is an ISO 13485-certified company that operates in line with cGMPs and international standards, enabling advanced therapy developers to de-risk their supply chains and facilitate regulatory approval. The company's unique business model emphasizes knowledge, flexibility and unparalleled service—from development through to commercialization.
Delivering World-Class Biotechnology-Based Products
Cytokines & Growth Factors: Akron’s high-quality cGMP Recombinant Proteins offer the consistency, safety, and efficacy that empower today’s leading clinical and commercial cell therapy companies. Every decision made in cGMP manufacturing affects the end patient. This is why Akron Bio employs robust pharmaceutical grade purification strategies (IEX/SEC/TTF) and always adheres to international standards and guidelines when available. This results in recombinant proteins with exceptional characterization, purity, and lot-to-lot consistency. With first in industry FDA eCTD Master Files covering its leading cytokines & growth factors, it has a proven track record of prioritizing the customer’s regulatory requirements to make their drug approval process simple. Akron’s knowledgeable product, quality, and regulatory groups are committed to your therapy’s success.
Human Plasma Derived Products: Akron’s proven blood products deliver safety and performance backed by robust and redundant supply. Because the company believes that you can’t afford to compromise. Its human blood-derived products are engineered specifically with its advanced therapy customer’s needs in mind. The company has designed each of these products to deliver optimal cell growth and viability within cGMP manufacturing processes, never compromising on safety and lot-to-lot consistency. These products are backed with comprehensive manufacturing and pathogen safety documentation that aims to meet commercial regulatory requirements of leading health authorities within the US, EU, and Asia.
It manufactures custom recombinant proteins, media and cell and gene therapy products based on your specifications, including all under cGMP. Capitalizing the established platform for manufacturing cGMP-compliant clinical and commercial grade ancillary products is also done. Its broad expertise and vision are highly sought after, particularly for challenging projects which demand carefully considered approaches.
Media & Media Supplements: Akron offers critical media supplements in both cGMP and high-quality research grade. They pride themselves in their long history of flexible collaboration with the customers to manufacture or source vital reagents with the appropriate documentation and quality support. Akron’s Recombinant Human Insulin (rHu Insulin) products are manufactured following all relevant cGMP guidelines for ancillary materials and are supported by a Type II Master File (MF), which can be referenced by the FDA during your drug or biologic application process. Its rHu Insulin amino acid sequence is identical to native human insulin. Extensive physico-chemical characterization studies have been conducted and similar quality attributes are found when compared directly against Novolin® R (insulin human injection).
The Visionary Leader at the Helm of Akron Bio
Robert “Bob” Wedinger, PhD serves as the Chief Executive Officer of Akron Bio. He has over 30 years of experience in the specialty-chemicals industry. After a post-doctoral research appointment at Harvard University, he joined FMC Corporation, holding a number of positions of increasing responsibility in the Specialty Chemicals Group before moving to Honeywell International (Allied Signal). At Honeywell, Bob rose from Director of Research to Vice President and General Manager of the Pharmaceutical Fine Chemicals business. Bob then served as Vice President and General Manager of the Consumer Products and the Performance Materials businesses at JM Huber. Bob joined Chemtura Corporation in 2006 and rose to Chief Business Officer and Group President, Performance Materials in 2007 with responsibility for all of Chemtura’s businesses. Bob joined Rennovia, a start-up company, in 2009 as President and CEO. He has provided advisory services to private equity firms, and has been exclusively advising Arcline Investment Management on investment opportunities in the specialty chemicals, personal care, and life science sectors since May 2019. Dr. Wedinger has a PhD in Chemistry from the State University of New York at Stony Brook.