Recent News

What’s Happening at GRAM

July 2016 – GRAM Names Colleen Herczak as Director of Quality Assurance and Regulatory Affairs

July 13, 2016 – Grand River Aseptic Manufacturing names Colleen Herczak as Director of Quality Assurance and Regulatory Affairs.

Grand River Aseptic Manufacturing (“GRAM”) announced today the addition of Colleen Herczak to the Company’s executive team. Herczak brings 15 years of experience in Quality Assurance and Quality Control in the life sciences industry. Herczak commented, “I am very excited to join the GRAM team! The business and quality systems at GRAM are customer-focused and strong and I’m thrilled to be a part of a company with this type of culture.”

Prior to joining GRAM, Colleen started her career in the analytical lab at Perrigo, primarily supporting product release. Following Perrigo, she joined Emergent BioSolutions where she held various positions of increasing responsibility within the Quality department and most recently held director-level positions leading teams within the Information Technology and Quality departments.

Her track record of implementing compliant, enterprise-wide business systems, lean manufacturing systems, and quality management systems will complement GRAM’s core practices and support continued growth and improvement. Colleen earned a B.S. in Biomedical Science and Chemistry from Grand Valley State University and a Masters in Quality Management from Eastern Michigan University. Additionally, she is a Certified Manager of Quality/Operational Excellence through the American Society for Quality (ASQ).

In announcing this latest addition to the team, GRAM President and CEO, Tom Ross, noted “Colleen’s experience in the life sciences industry, her oversight of sterile manufacturing operations, and work with analytical laboratory testing, validation and lot release will be vital to continue GRAM’s position as a leader in the life sciences industry in Michigan. We are proud to have her join the team.”

Colleen also stated, “I am enthusiastic about the opportunity to work with the GRAM team to continue improving the effectiveness of our systems to support our future growth plans, while ensuring that we maintain the Company’s superior quality record.”

Grand River Aseptic Manufacturing

Grand River Aseptic Manufacturing (GRAM) is a parenteral contract manufacturing organization supporting new product development and cGMP manufacturing. With a state-of-the-art cleanroom and highly trained staff, GRAM provides clinical trial and commercial material in vials or syringes for the life sciences industry.

GRAM specializes in pre-clinical, clinical, and commercial manufacturing and offers the following services: sterile product development and manufacture, lyophilization, terminal sterilization and analytical and microbiological testing, stability sample storage, labeling and packaging storage and distribution.

April 2016 – GRAM in MiBiz

MiBiz Article – April 6, 2016

Grand River Aseptic Manufacturing completes $1.1 million raise

Written by 

 GRAND RAPIDS — Grand River Aseptic Manufacturing Inc. completed a $1.1 million round of fundraising from investors last month.

The contract manufacturer of sterile injectable products for the pharmaceutical industry plans to use the financing to support the momentum the company gained over the last year, said President and CEO Tom Ross.

Grand River Aseptic more than tripled its annual revenues in that period, he said.

“We’re really excited and proud of what we can accomplish and to create a thriving life sciences company here on the banks of the Grand River,” Ross told MiBiz. “We want to support that (investment) by continuing to grow. We’re lucky enough to have a strong investor base that wants to continue to support the company.”

Specifically, Grand River Aseptic has invested a portion of the money into purchasing new sterile water injection equipment and additional redundancy technology such as filters, pumps and other systems, Ross said.

The company also plans to use a portion of the funds to support additional hiring. Grand River Aseptic employs 120 workers — more than twice the people it employed in 2014 — and plans to continue to hire workers as new contracts come online, Ross said.

Grand River Aseptic generated more than $10 million in revenue in 2015, he said.

The company raised $1.1 million of a possible $2 million, according to documents filed with the Securities and Exchange Commission.

The manufacturer’s latest fundraising follows a $9.8 million round of financing in 2014, led by the Municipal Employee’s Retirement System of Michigan, as MiBiz reported at the time. The company used that investment to add new customers to its contract manufacturing business.

Ross expected Grand River Aseptic to continue along a strong growth trajectory as pharmaceutical companies increasingly turn to contract manufacturers to reduce overhead costs and help bring products to market.

The global pharmaceutical contract manufacturing market is expected to grow to $84 billion by 2020, according to a March 2016 report published by market research firm Mordor Intelligence. At the same time, global pharmaceutical sales are expected to reach $1.61 trillion in 2018, up from $1.23 trillion in 2014, according to a global life sciences outlook report published last year by Deloitte.

“Products are selling well in the market, and we’re excited about being able to respond to that and continue to increase our output,” Ross said.

– See more at: http://mibiz.com/item/23523-grand-river-aseptic-manufacturing-completes-#sthash.oQeMYOMf.dpuf

February 2016 – GRAM Announces Successful FDA Inspection, No Form 483 Issued

February 10, 2016 – Grand River Aseptic Manufacturing, Inc. (“GRAM”) is proud to announce the successful completion of its fourth Food and Drug Administration (FDA) inspection at its contract parenteral manufacturing facility in Grand Rapids, MI.

The seven-day FDA inspection included a general GMP and a Pre-Approval Inspection. At the conclusion of the inspection, GRAM was found to be in compliance with Current Good Manufacturing Practices and passed the Pre-Approval Inspection, with no Form 483 observations issued.

At the completion of the inspection, Tom Ross, President and CEO at GRAM said, “GRAM team members proved that dedication to superior regulatory and quality performance is the only way to operate. We are thrilled to deliver this news to our clients and I congratulate the entire GRAM team on a job well done. Each year, our top five strategic objectives start with superior regulatory performance. Our company focus will always be on quality, and receiving zero 483s is a fantastic achievement.”

The outcome of the inspection shows GRAM’s commitment to delivering a quality product to its clients. In addition to the explosive growth the company is experiencing, being compliant with FDA principles and regulations remains at the top objective for all GRAM team members. GRAM views its relationship with the FDA as a partnership and this latest achievement demonstrates the success of operating in that manner.

COO Connie Degen stated, “Since the company was formed in December 2010, GRAM has successfully completed all four of our FDA Inspections, with this last one being the most successful. We welcome the FDA’s return each year and are proud to demonstrate our dedication to following cGMPs and to the quality of our client’s products. This is a crucial step for GRAM’s positioning in the industry as a leading contract manufacturing organization.”

Grand River Aseptic Manufacturing

Grand River Aseptic Manufacturing (GRAM) is a parenteral contract manufacturing organization supporting new product development and cGMP manufacturing. With a state-of-the-art cleanroom and highly trained staff, GRAM provides clinical trial and commercial material in vials or syringes for the life sciences industry.

GRAM specializes in pre-clinical, clinical, and commercial manufacturing and offers the following services: sterile product development and manufacture, lyophilization, terminal sterilization and analytical and microbiological testing, stability sample storage, labeling and packaging storage and distribution.

 

December 2015 – Grand River Aseptic Manufacturing, Inc. Highlights Disposable Technology Capabilities

December 9, 2015 – Grand River Aseptic Manufacturing, Inc. (“GRAM”) expands disposable technology capabilities at its FDA-approved manufacturing facility in Grand Rapids, Michigan.

Over the past year, GRAM has added numerous capabilities to improve the overall service provided to clients, the latest of which is disposable technology. Disposable technology (also known as ‘Single-Use Systems (SUS)’) is one of the most important and valuable added capabilities due to its complementary benefits to both GRAM and the client.

The benefit of disposable technology to the client is threefold: (1) cost savings; (2) time savings; and (3) improved safety and quality standards associated with SUS. As compared to the stainless steel system alternatives, process development timelines for disposable technology are greatly reduced.  Additionally, there is greater flexibility in process design process which contributes to an overall lower capital cost.  Also, by nature of being an SUS, client cross-contamination risks have been greatly mitigated.

By utilizing disposable technology, GRAM is able to benefit from efficiency gains by reducing processing time, cleaning time, and prep time. Manufacturing downtime is also reduced due to the elimination of validation activities that come with the cleaning process. Eliminating the cleaning processes and validation activities also allows GRAM to realize costs savings associated with water-for-injection.

Steve Nole, GRAM’s Director of Manufacturing, stated, “We’re excited to offer expanded disposable technology capabilities. This will enable us to respond more quickly to client needs and ultimately reduce their costs.”

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