Velesco Pharma

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Channing Rupnick

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Aug 4, 2024, 8:25:39 PM8/4/24

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MINNEAPOLISOct. 11, 2021 (GLOBE NEWSWIRE) -- Pace Analytical Life Sciences, LLC, a subsidiary of Pace Analytical Services, LLC, a full-service contract development and manufacturing organization (CDMO), today announced that it has acquired Velesco Pharmaceutical Services, Inc. Velesco, also a CDMO, specializes in liquid, semi-solid, and oral solid dose product development.

"Pace scientists and professionals provide expertise and support to clients throughout their drug development timeline," said Eric Roman, CEO of Pace Analytical. "Adding Velesco to our portfolio is representative of our commitment to supporting customers across the drug delivery spectrum."

The acquisition of Velesco allows Pace to extend a range of support options; from binary solutions to complicated self-emulsifying drug delivery systems (SEDDS) and tailor them to the client's molecule, dose range, and drug delivery route. Velesco also extends the expertise, experience, capabilities, and clinical trial material manufacturing capacity that Pace brings to clients, including:

Velesco co-founder and CEO David Barnes, Ph.D., will transition to Vice President, Scientific Affairs, and Velesco co-founder and COO Gerry Cox will assume the role of Vice President, Commercial Development at Pace. In their new roles, they will maintain and extend their impressive legacy of serving clients while adding key insights and leadership to the Pace network.

"Dave Barnes and Gerry Cox have much to offer to the Pace team, and we are excited to have them continue on in key roles," notes Greg Kupp, President of Pace Life Sciences. "The reputation of the Velesco team, their strong history and flexible response to client demand, make this a great cultural fit while adding tremendous value to our clients."

In the coming months, Velesco will transition to the Pace brand. Velesco operates two sites in Wixom, MI and joins Pace Life Sciences locations near Boston, MA, St. Paul, MN, Philadelphia, PA, Salem, NH, and San Germn, PR.

Velesco Pharma was formed by former big pharma R&D colleagues and focuses on supporting early and later stage drug development. Velesco provides fast and cost-effective contract analytical development and drug formulation services, along with cGMP clinical supplies offering a full range of non-sterile dosage forms. The team offers personalized project management, state-of-the-art facilities and an experienced laboratory staff leading to comprehensive research relationships. More at Velescopharma.com.

Pace Analytical Life Sciences, LLC. is a network of full-service contract CMC development and GMP analytical testing laboratories. CMC development, chemistry, and microbiology central lab testing services are provided to the pharmaceutical, biopharmaceutical, and gene therapy manufacturing industries. Our investment in state-of-the-art facilities and highly-trained experts emphasizes our commitment to delivering positive customer experiences across all channels of our business. We are dedicated to providing not only the best analytical testing services but the most reliable. A subsidiary of Pace Analytical Services, LLC, Pace Analytical Life Sciences operates FDA-registered laboratory testing facilities in Oakdale, Minnesota, San German, Puerto Rico, and CDMO facilities in Woburn, Massachusetts, Salem, NH, Philadelphia, PA, and Wixom, MI. Learn more at PACELABS.com

Pace Analytical Services, LLC makes the world a safer, healthier place. For decades, we have been the trusted source for quality life sciences and environmental lab testing and analysis and the resource for scientific lab staffing, regulatory, and equipment services. Our work is done in partnership with our clients by providing the science and the data they need to make critical decisions that benefit us all. Pace delivers science better to businesses, industries, consulting firms, government agencies, and more through the largest, American-owned, and nationally certified laboratory network. Science matters at PACELABS.com

In June 2009, Velesco opened a new facility to increase its manufacturing capabilities. Located in Kalamazoo Commerce Center, Michigan, the facility will manufacture clinical supplies to be used by pharmaceutical companies in their early phase trials.

The 10,000ft2 facility is devoted to the manufacture of non-sterile cGMP clinical trial supplies for pharmaceutical companies that are into developing new medicines. Registered with the US Food and Drug Administration, the facility is suitable for filling oral powder into bottles and capsules, oral liquids, transdermal liquids/creams and ointments.

Within the facility there is one clean room, two warehouses and ten offices. The total warehouse area is 2,500ft2, while the office and the manufacturing unit occupy an area of 2,000ft2 and 1,500ft2 respectively.

The clean room has two processing suites, each extending 120ft2. These suites will be equipped with a Schaefer10B over-encapsulation equipment, bottle cap torque applicator, powder pipettes, balances, automated filling equipment and blenders.

To test the drug product before its release, the facility will also add a GMP laboratory. The lab will be equipped with high-performance liquid chromatography, dissolution apparatus, a fume hood and stability chambers. It will be operational by October 2009.

The facility will produce materials used for Phase I and Phase II clinical trials. Product offerings will include powder-in-capsule, powder-in-bottle, ointments and creams, oral and topical liquids, over-encapsulation for blinded studies and packaging. The facility will focus on manufacturing powder-in-capsule, powder-in-bottle, topical and non-sterile liquid dosage forms.

The company has adopted a hand-filling method to insert bulk active pharmaceutical ingredients (API) material into hard or soft gelatine capsules or vials. The same is used for filling liquids into soft gelatine capsules or vials. Larger tablets are blended via a new over-encapusalation technology that avoids the need for additional processes.

The operations take place in real time. Similar to compounding in clinic, a continuous process takes place in Velesco. The lots are released in real time. Batches are shipped to the clinic immediately after the entire process is completed, within a day. The lot does not undergo any stability testing. The expiration date is set based on API stability while the beyond-use date is set based on the experimental study performed in the formulation lab.

The space for the new facility has been taken on lease. The facility already has a building that was previously used as GMP clinical manufacturing facility by Komodo Pharmaceutical Services, a contract manufacturing outsourcing company that specialises in over-encapsulation.

Velesco Pharmaceutical Services, Inc., has announced the award of a subcontract for analytical method development, manufacturing clinical supplies, and testing the stability of an investigational drug for the treatment for Beta-Thalassemia, a blood disorder that reduces the production of proteins that carry oxygen to cells throughout the body.

About Velesco Pharmaceutical Services, Inc.

Velesco Pharmaceutical Services, Inc. is a privately held contract development and manufacturing organization with a focus on providing drug product services to pharmaceutical and biotech companies with early stage drug development programs.

About The Frederick National Laboratory for Cancer Research

The Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research, Inc. for the National Cancer Institute, is dedicated to improving human health through discovery and innovation in the biomedical sciences, focusing on cancer, AIDS, and emerging infectious diseases.

Acquisition adds significant experience and expertise in the development of liquid, semi-solid, and oral solid dose products for pre-clinical and clinical use allowing Pace to support a growing number of clients throughout the drug development process.

Velesco co-founder and CEO, David Barnes, Ph.D. will transition to Vice President, Scientific Affairs, and Velesco co-founder and COO, Gerry Cox, will assume the role of Vice President, Commercial Development at Pace. In their new roles, they will maintain and extend their impressive legacy of serving clients while adding key insights and leadership to the Pace network.

Velesco Pharma was formed by former big pharma R&D colleagues and focuses on supporting early and later stage drug development. Velesco provides fast and cost-effective contract analytical development and drug formulation services along with cGMP clinical supplies offering a full range of non-sterile dosage forms. The team offers personalized project management, state-of-the-art facilities and an experienced laboratory staff leading to comprehensive research relationships.