CMC Pharmaceuticals Inc. sponsored Drug Delivery West Summit
Date: June 2, 2021
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CMC Pharmaceuticals Inc. (CMC Pharma), a contract services company providing drug product laboratory and consulting services to the pharmaceutical/biotechnology industry, announced their Supporting Sponsorship for the 3rd Annual Drug Delivery West (DDW) Summit.  The DDW Summit provides a virtual platform for biopharmaceutical companies to discuss and explore partnership opportunities utilizing novel drug delivery solutions.  The summit includes virtual meetings and forums covering a broad range of topics in drug delivery. The summit was held virtually on May 17th and May 18th with two additional days of partnership meetings.

Founded in 2014, CMC Pharma’s business model includes drug product consulting and lab services for a wide variety of drug development programs ranging from immediate-release to long-acting injectables. The company’s drug delivery efforts are focused on cost effective solutions that utilize the PLGA (poly(lactic-co-glycolic acid)) family and SAIB (sucrose acetate isobutyrate) biocompatible polymers.  The company is located in Northeast Ohio with office, laboratory, pilot plant and expansion space available in the Cleveland and Solon locations.  

CMC Pharma’s experience includes multi-year projects for commercial customers and the United States Federal Government.  In 2019, CMC Pharma added cGMP lab services to support its development services for pharmaceutical drug products.  

“We are committed to providing breakthrough drug delivery solutions to address medical needs with unique and innovative approaches,” stated Dr. Mike Radomsky, Founder and President of CMC Pharmaceuticals. “It is our mission to contribute to the development of successful drug products to meet critical and unmet medical needs.”

 

About CMC Pharmaceuticals, Inc.:

 

CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. CMC Pharmaceuticals delivers its specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development and consulting services to clients globally. CMC Pharmaceuticals offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile, solid, semi-solid/liquid, topical, long-acting, controlled release, and other complex dosage forms. 

 

For further information contact:

Simone Stanley, MS
Business Development Associate
simone.stanley@cmcpharm.com
www.cmcpharm.com

 

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CMC Pharmaceuticals, Inc. Launches New Website Describing its Laboratory Services
Date: August 25, 2020
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CMC Pharmaceuticals, a leading provider of drug product development services, announces that it has updated its website to better describe its drug product development services.  Since its founding in 2014, CMC Pharma has increased the depth and breadth of the chemistry services that it provides:

  • FORMULATION DEVELOPMENT – CMC Pharma scientists are experts in the development of traditional oral, injectable and complex controlled release dosage forms.  Scientists have contributed to developing drug products for a broad range of active pharmaceutical ingredients (API), including drug products that are challenging to stabilize, solubilize or need a sophisticated drug delivery system. 
  • DRUG DELIVERY SYSTEMS – CMC Pharma provides expertise in selecting and developing drug delivery systems.  The company’s focus is not on its own proprietary drug delivery technology, but rather the selection of a drug delivery system that considers the target product profile and not one specific technology.  CMC Pharma uses proven approaches to develop long acting drug product formulations and are specialists with extensive experience in formulation and analytical development of competing drug delivery technologies appropriate for active ingredients with varying characteristics. 
  • ANALYTICAL CHEMISTRY – CMC Pharma scientists have tested hundreds of pharmaceutical drug products, and our scientists are experts in method development, validation, and execution in techniques that include U/HPLC, LC- MS, Karl Fisher, osmolarity, dissolution, in vitro release testing and other analytical instrumentation.  Our expertise includes development and validation of potency and related substances stability indicating methods.  Testing experience includes evaluating APIs, drug products, excipients, and reference standards, including utilizing a vast majority of USP tests.
  • STABILITY SERVICES – CMC Pharma executes a wide variety of standard ICH and custom designed stability studies to support the development and approval of drug products and APIs. Studies can be performed following cGMPs, when necessary, and include most ICH and custom storage conditions.  The company can support studies for shelf-life and expiry dating after long-term storage, reconstitution, or dilution; freeze-thaw, UV and visible light exposure; or moving from one storage condition to another (e.g., transfer from refrigeration to room temperature).  
  • cGMP LAB SERVICES – CMC Pharma offers cGMP lab services to support product development.  These services include upgraded laboratory SOPs and documentation practices to comply with U.S. FDA guidelines. Data generated in CMC’s labs may be included or used to support clients regulatory filings with the U.S. FDA when cGMP lab studies are required.  These documents can be included in U.S. FDA submissions and other worldwide markets when needed.
  • CMC PHARMA CONSULTING – CMC Pharma has a proven track record in evaluating, developing, and manufacturing drug products for global markets.  Our wealth of experience in the development and manufacturing of a wide range of drug products uniquely qualifies CMC Pharma to identify strategic solutions for the most demanding drug development programs. CMC Pharma provides phase-appropriate technical expertise to satisfy FDA and other worldwide regulatory requirements helping to ease the pathway to regulatory approval.

CMC Pharma’s laboratories in Cleveland and Solon, Ohio are well equipped for the formulation and analysis of pharmaceutical drug products. This allows CMC to provide valuable technical expertise on a broad range of drug product development disciplines for both short term and multi-year projects and provide customers with critically needed drug product development functions.   

“CMC Pharma’s updated website more accurately describes our commitment to developing robust formulations needed for drug approval and large scale manufacturing.  Our organization is well positioned to provide chemistry, manufacturing, and controls expertise to the commercial pharmaceutical and biotechnology industries as well as the Federal Government,” stated Dr. Mike Radomsky, Founder and President of CMC Pharmaceuticals.  “CMC works with our prestigious clients to advance their pharmacotherapies and medical countermeasures to address unmet medical needs.” 

About CMC Pharmaceuticals, Inc.:

CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. CMC Pharmaceuticals delivers its specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development and consulting services to clients globally. CMC Pharmaceuticals offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile, solid, semi-solid/liquid, topical, long-acting, controlled release, and other complex dosage forms. www.cmcpharm.com

 

For further information contact:

Casey Loveland, Business Manager

CMC Pharmaceuticals, Inc.

7100 Euclid Avenue

Cleveland, OH  44103

casey.loveland@cmcpharm.com

info@cmcpharm.com

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CMC Pharmaceuticals, Inc. Continues Operations and Laboratory Services During COVID-19 Pandemic
Date: May 13, 2020
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CMC Pharmaceuticals, a leading provider of drug product development services, announces that operations at its Ohio locations have continued and expanded during the COVID-19 pandemic. Our administrative functions have been effective working remotely, and CMC has established on-site guidelines to protect our employees with appropriate social distancing and other procedures in our laboratories. In the previous 12 months, CMC Pharma has:

  • Continued operations throughout Ohio’s Stay at Home Order as an Essential Business that provides laboratory and product development services to our pharmaceutical and biotechnology customers.
  • Expanded our long-acting, controlled-release drug delivery capabilities with a focus on cost-effective solutions.
  • Established a manufacturing pilot plant to produce a wide variety of oral, injectable, and long-acting drug product prototypes.
  • Expanded lab instrumentation and personnel to double our analytical capacity with new ICH Stability Chambers, UHPLCs, and other analytical instrumentation.
  • Established cGMP laboratory capabilities for analytical development and validation, stability and compatibility studies, and drug product release testing
  • Added additional personnel protective equipment (PPE) and lab safety equipment for the safe handling of potent actives.
  • Expanded our relationship with the Federal Government for the development of drugs by winning multiple DOD grants and contracts
  • Submitted COVID-19 proposals to identify and develop pharmacotherapies by providing chemistry, manufacturing, and controls (CMC) support (e.g., manufacturing scale-up).

These milestones and capabilities have provided services to our customers for the development of critically needed drug products. CMC Pharma has continued to expand our lab services to develop or improve drug product formulations, prepare prototypes of a variety of dosage forms, conduct stability and material compatibility studies, and create or optimize analytical methods that are suitable for inclusion in our clients U.S. FDA and other worldwide regulatory submissions.

“CMC Pharma was started nearly 6 years ago to quickly develop robust formulations needed for drug approval and large scale manufacturing. Our organization is well positioned to help identify, scale-up and test formulations to ensure Quality drug products that are critically needed to fight the current pandemic,” stated Mike Radomsky, Founder and President of CMC Pharmaceuticals. “CMC is excited to partner with other organizations to develop new treatments for COVID-19 and will continue our partnerships to advance pharmacotherapies and other medical countermeasures to address unmet medical needs.”

About CMC Pharmaceuticals, Inc.:

CMC Pharmaceuticals is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries. CMC Pharmaceuticals delivers its specialized scientific expertise and services including pre-formulation, formulation development, analytical development, cGMP lab services, stability and compatibility studies, manufacturing process development and consulting services to clients globally. CMC Pharmaceuticals offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile, solid, semi-solid/liquid, topical, long-acting, controlled release, and other complex dosage forms. www.cmcpharm.com

 

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CMC Pharmaceuticals, Inc. Announces Launch of cGMP Laboratory Services
Date: October 30, 2019
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CMC Pharmaceuticals has added current Good Manufacturing Practices (cGMP) lab services at its Solon, OH location on October 1st. This addition includes the upgrading of laboratory SOPs and documentation practices to comply with U.S. FDA guidelines. Now, data generated in CMC’s lab may be included or used to support contract customer’s filings with the U.S. FDA when cGMP lab studies are required. CMC Pharmaceuticals can now develop or improve drug product formulations, prepare prototypes of a variety of dosage forms, conduct stability and material compatibility studies, and create or optimize analytical methods that are suitable for inclusion in their clients U.S. FDA submissions.

This upgrade in capability extends CMC Pharmaceuticals ability to support their customer’s needs in drug product development services. “We started this organization five years ago to help pharma and biotech companies develop robust drug products faster,” said Mike Radomsky, Founder and President of CMC Pharmaceuticals. “This logical expansion of our service offering is in response to the expanding needs of our valued customers and allows us to directly support them with their submissions to the FDA”.

CMC Pharmaceuticals continues to operate its Mid-town Cleveland laboratory with a focus on R&D services, providing for early stage research laboratory services.

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CMC Pharmaceuticals, Inc. Celebrates Five Years
Date: October 29, 2019
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Cleveland, Ohio – October 14, 2019

CMC Pharmaceuticals announces a celebration of the five-year anniversary of its founding on October 3, 2019. CMC Pharmaceuticals hosted the celebration at its newest laboratory location. Guests were customers, suppliers and local government, including Solon (Ohio) Mayor Ed Kraus, Solon Director of Business and Marketing, Angee Shaker, Solon Councilman, Bill Russo and 14th District Congressman David Joyce’s Representative, Katie Burger. The event included a tour of CMC Pharmaceutical’s facilities to mark the important occasion.

Dr. Mike Radomsky founded CMC Pharmaceuticals in 2014, based on a mission to help pharma and biotech companies, non-profit institutions, and government agencies develop high-quality drug products more efficiently. CMC Pharmaceuticals added laboratory facilities in 2015 to provide experimentally-based, data-driven development solutions to address its customer’s drug product development and manufacturing challenges. The company has grown to two laboratory locations in the Cleveland area and increased its staff from just the original founder, to now include 10 highly experienced team members with advanced scientific backgrounds. 

The majority woman-owned business now offers fully integrated formulation development, analytical development, drug product stability, and process development services from its own R&D and current good manufacturing practices (cGMP) laboratories.  CMC Pharmaceuticals co-founder Casey Loveland commented, “ The Cleveland area has been a great place to grow our business, with its central location, and highly developed medical and scientific infrastructure. It has definitely contributed to the acceleration of our growth”. 

“Having started a single person consulting firm that now successfully operates as a growing organization with a wide range of global customers is a great achievement for CMC Pharmaceuticals,” said Mike Radomsky, Founder and President of CMC Pharmaceuticals. “Over the last 5 years we’ve expanded our services and operations to meet our customer’s needs. We’ll assess new opportunities to continue that strategic growth moving forward.”

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