The Importance of Stability Studies in Pharmaceuticals
Date: June 7, 2022
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The Importance of Stability Studies in Pharmaceuticals

Stability studies in pharmaceuticals are performed from early development through regulatory approval and commercialization. Understanding the stability and shelf-life of a pharmaceutical drug product (DP, or Finished dosage form) and drug substance (DS or active pharmaceutical ingredient, API) is a critical quality component to ensure the safety and efficacy of the product throughout its lifecycle.

Stability studies typically begin at the preclinical stage of drug development and continue through clinical trials to support formulation development and satisfy the regulatory requirements for clinical trials, approval, and commercialization. Stability studies have the primary objective of ensuring DP and DS retain their potency, purity, and other quality attributes throughout the product’s shelf life to ensure the safety and efficacy of the drug. The purpose of stability testing is to provide evidence on how the quality of a DS or DP varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or shelf life for the drug product. Shelf life can be influenced by many factors, including the intrinsic stability properties of the active ingredient, the choice and level of the excipients in the formulation, the drug product manufacturing process, and the selection of the container closure components, and packaging design.

Understanding the Objectives of Stability Studies

Stability studies are performed to support multiple objectives at each of the product development stages. As pre-formulation, formulation, and pilot stability data is generated, the studies typically advance from exploratory studies to identify a formulation and initial storage condition to confirmatory studies to justify shelf-life for a regulatory filing and product approval. The goals of stability studies include: identifying the most stable drug candidate, identifying the drug degradation mechanisms and chemical pathways, supporting GLP non-clinical studies, determining appropriate DS and DP storage conditions, estimating shelf-life of formulation candidates, evaluating alternate drug product packaging, evaluating proposed shipping conditions, extending shelf-life, and more.

It is important to understand the criticality of developing and selecting the appropriate analytical methods to evaluate DS and DP stability to ensure product potency and purity. Analytical methods must be stability-indicating that can detect the change with time in the chemical, physical or microbiological properties of the DS or DP. These methods are specific so that the content of active ingredients and degradation products can be determined accurately without interference from formulation excipients.

Forced degradation and stress testing techniques are typically employed by exposing the DS and DP to conditions that exceed those used for accelerated stability testing and that the product is typically exposed. Degradation is intentionally achieved by exposing the drug to pH extremes (acid and base), heat (elevated temperatures, i.e. 80°C), oxidizing agents (e.g., hydrogen peroxide), light (UV and visible) and other extreme conditions. This intentional degradation of the API must be detected in the selected analytical methods to ensure that the methods are stability indicating. ICH publishes Guidelines on the development and validation (Q2 and Q14) of appropriate analytical methods.

Early Stage Studies

CMC Pharmaceuticals routinely performs stability studies in our lab. Early in the drug development process stability studies are performed to identify drug candidates that have better stability characteristics than alternatives and to ensure the selected compound(s) have sufficient stability characteristics for an adequate shelf-life. The purpose in this phase of development is to identify the most stable drug candidate to ensure feasible commercialization

Stability studies are also executed early in development to determine chemical degradation pathways (e.g., hydrolysis, oxidation, light mediated, etc.) of the active pharmaceutical ingredient. An understanding of the degradation mechanisms is critical to advance to the next stage of development that identifies a stable formulation for the drug product for use in non-clinical or clinical studies. Understanding the degradation mechanism is used to identify and evaluate stabilizing strategies of the drug product (e.g.,, minimizing hydrolysis, protecting from light, eliminating oxygen with inert gas overlays or oxygen scavengers).

Late Stage Stability Evaluations

The purpose of the stability studies in late development is to establish, based on testing a minimum of three batches of DS or DP, a re-test or shelf-life period that is applicable to all future batches. ICH has published Guideline Q1E, “Evaluation for Stability Data” to provide recommendations on how to use stability data to propose shelf life in a registration application. ICH Q6A and Q6B Guidelines should be consulted for recommendations on the setting and justification of acceptance criteria, and ICH Q1D should be referenced for recommendations on the use of full- versus reduced-design studies. The Q1E guideline describes when and how extrapolation can be considered when proposing shelf life for a drug product that extends beyond the covered available data from stability studies under the long-term storage condition.

A systematic approach should be adopted in the presentation and evaluation of the stability information. The stability information should include, as appropriate, results from the physical, chemical, biological, and microbiological tests, including those related to particular attributes of the dosage form (for example, dissolution rate for solid oral dosage forms). When extrapolating stability data to determine drug product dating, shelf life can be no longer than the time when the 95% confidence limits (CL) of the regression line first intersect the acceptance criteria. This analysis should be done for each attribute to determine the earliest time the regression line intersects with the acceptance criteria; the proposed shelf life can be no longer than this time. It is important to ensure that sufficient stability data is available to support extrapolation.

CMC Pharma Helps You Navigate Stability Studies

CMC Pharma has expertise in performing stability studies throughout every stage of drug product development. These studies can initially be exploratory to learn about the intrinsic stability of the drug compound, select developable compounds for further development, and evaluate formulation approaches to support commercialization. As drug development programs mature and near completion of clinical trials, stability studies become more confirmatory to support and justify a shelf-life and product approval. The team at CMC Pharma can help design and guide you through these studies. Contact Us today!

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CMC Pharmaceuticals Expands Chemical Defense Portfolio
Date: May 5, 2022
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Department of Defense Awards CMC Pharma SBIR Grant, Adding to Existing Chemical Defense Portfolio

 

Solon, OH: The Department of Defense’s (DoD) Chemical and Biological Defense (CBD) Small Business Innovation Research (SBIR) program awarded CMC Pharmaceuticals an SBIR contract managed by the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) (Contract number: W911SR-22-P-006). The Phase I SBIR award will fund the formulation and analytical development of a multi-dose scopolamine hydrobromide trihydrate vial.  The application of this new formulation aims to reduce the logistical burden to military first responders when treating mass exposure to organophosphorus nerve agents (OPNAs). 

 

“The team at CMC Pharma is honored to continue assisting the US Military with the award of this SBIR grant,” said Dr. Radomsky, Principal Investigator and President of CMC Pharma. “We will leverage our medical countermeasure development and scopolamine drug product development experience to help the US military treat and prevent casualties against nerve agent exposure.”

 

Currently, a single dose scopolamine vial is being developed alongside an autoinjector to provide adjunct therapy for military personnel exposed to nerve agents. However, a multi-dose scopolamine vial would provide a broader range of options in the different military medical care roles. CMC Pharma will complete the chemistry, manufacturing, and controls development (formulation, analytical, process, and stability studies) of a multi-dose presentation of the scopolamine drug product containing an antimicrobial preservative.

 

Upon the development of the multi-dose vial, CMC Pharma plans to execute future studies to support FDA approval of the drug product and secure the appropriate supply chain including cGMP manufacturing.  CMC Pharma aims to commercialize this drug product for inclusion in the national strategic stockpile.

 

This program complements CMC’s other medical countermeasure development programs for pre- and post- organophosphate exposure for civilian and military applications.  For more information about CMC Pharma’s team, services, and potential partnering opportunities, please contact Jared Heimovitz at jared.heimovitz@cmcpharm.com and visit www.cmcpharm.com.

 

About CMC Pharmaceuticals:

 

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.

 

CONTACT: 

Jared Heimovitz
CMC Pharmaceuticals
440-485-1734
jared.heimovitz@cmcpharm.com

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CMC Pharmaceuticals Awarded SBIR Grant For Concentrated Atropine Formulation
Date: April 6, 2022
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CMC Pharmaceuticals Awarded SBIR Grant For Concentrated Atropine Formulation

Solon, OH: CMC Pharmaceuticals has been awarded a Small Business Innovation (SBIR) grant from U.S. Special Operations Command (SOCOM). The Phase I SBIR award will fund the formulation and analytical development of a concentrated Atropine Sulfate Drug Product. The application of this new formulation aims to aid the military in treating organophosphate poisoning in service members. 

“CMC Pharma has significant experience developing injectable atropine and related formulations for medical countermeasures,” said Dr. Radomsky, Principal Investigator and President of CMC Pharma. “The team is honored to have been awarded the SBIR and we are thrilled to support the Department of Defense and SOCOM by developing pharmaceutical products to protect our service members.”

The objective of the formulation is to reduce the logistical burden in treating severe cases of organophosphate poisoning. Upon development of the concentrated atropine sulfate formulation, CMC Pharma plans to execute future studies to support FDA approval of the drug product and secure the appropriate supply chain.  CMC Pharma aims to commercialize the drug product for inclusion in the national strategic stockpile.

In addition to military uses for treating organophosphate poisoning of service members, atropine sulfate is indicated for the temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning, and to treat bradyasystolic cardiac arrest.  CMC Pharma intends to seek approval for all relevant military and civilian uses.   

For more information about CMC Pharma’s team and drug product formulation expertise, visit www.cmcpharm.com.

About CMC Pharmaceuticals:

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.

CONTACT: 

Jared Heimovitz
CMC Pharmaceuticals
440-485-1734
jared.heimovitz@cmcpharm.com

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CMC Pharmaceuticals Announces Collaborative Partnership
Date: March 15, 2022
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New Agreement with Federal Equipment Company Expands Companies Capabilities

Solon, OH: CMC Pharmaceuticals, a provider of drug product development services to the pharmaceutical and biotech industries, announces a collaborative partnership with Federal Equipment Company (“FEC”). FEC is a dealer of industrial processing equipment with a focus on pharmaceutical and chemical manufacturing. This agreement grants CMC Pharma access to a wider range of equipment, expanding prototype preparation and manufacturing process development capabilities.

“We’re thrilled to begin a mutually beneficial relationship with another company in Northeast Ohio,” said Dr. Mike Radomsky, President of CMC Pharma. “We’re hopeful that this partnership will bring increased awareness to the services provided by CMC and FEC. We look forward to expanding our capabilities with access to additional equipment, allowing us to further assist our clients.”

CMC Pharma will have access to a wider variety of pharmaceutical processing equipment to prepare prototypes and advance manufacturing process development at FEC’s facilities. 

Techceuticals, a training and consulting division of FEC, will also provide their services to CMC Pharma, as needed. They provide equipment training courses, drug formulation and development services, process troubleshooting, equipment sourcing, and equipment and process validation and documentation for solid-dose manufacturing (e.g. tablets, capsules, and powders) for customers manufacturing or developing drugs. In return, CMC Pharma will provide formulation and lab support services as requested by Techceuticals.

For more information about the agreement between CMC Pharma and Federal Equipment Company, visit www.cmcpharm.com/commercial-scale-development.

About CMC Pharmaceuticals:

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.

 

CONTACT:

Jared Heimovitz, Marketing & BD

CMC Pharmaceuticals

440-637-5865

jared.heimovitz@cmcpharm.com

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CMC Pharmaceuticals Announces New Advisory Board
Date: February 10, 2022
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CMC Pharmaceuticals Announces New Advisory Board

 

Solon, OH: CMC Pharmaceuticals, a provider of drug product development services to the pharmaceutical and biotechnology industries, announces the formation of an Advisory Board. The group of distinguished leaders will advise CMC Pharma on continued growth with a focus on cutting-edge science, business strategy, marketing, and risk reduction. The Members possess decades of experience in government, commercial, and academic research and development with demonstrated success including several biotech start-ups.

Board Members include Drs. John Patton, Mark Prausnitz, W. Mark Saltzman, Arthur Tipton, and Larry Zeitlin. Collectively, they have published hundreds of scientific articles, are tenured at some of the country’s top universities, started up and led established biotech and pharma companies, and have served on various fellowships and boards.

The Board held its first meeting virtually on January 24, 2022. Chairman, Dr. Arthur Tipton, has worked as an advisor to CMC Pharma for several years and expressed excitement for future engagements. “This group includes some of the most accomplished leaders in the drug development space. We look forward to celebrating wins with CMC Pharma and offering valuable strategic input to help them better serve their clients,” said Dr. Tipton.

The team at CMC Pharma, led by owner and co-founder, Dr. Mike Radomsky, helps clients with their drug product development efforts, ranging from early-stage formulation and analytical methods work to commercial-stage support.

At the inaugural meeting, Dr. Radomsky presented the 3-year growth plan and projections for expansion of drug development services, revenue, and employee headcount. With the Advisory Board’s help, CMC Pharma will expand the company’s reach while targeting specific opportunities for growth in the CDMO space. “The team at CMC Pharma has many decades of technical drug development experience, fast response times, and current capacity to begin new projects,” explained Dr. Radomsky. “The formation of an Advisory Board allows us to network and strategize with academics and industry leaders, navigating new routes for expansion while continuing to use our strengths to our advantage.”

The Advisory Board plans to have its first in-person meeting mid-2022 in Cleveland, Ohio. Members include:

Art Tipton, Chairman: Dr. Tipton is an independent consultant who aids companies in developing the next generation of drug delivery products. He was part of three successful drug delivery companies, including Founder and CEO of Brookwood Pharmaceuticals, now part of Evonik. He holds 43 U.S. patents and is an elected member of the National Academy of Inventors, the College of Fellows for the American Institute of Medical and Biological Engineering, The Controlled Release Society, and the National Academy of Engineers.

John Patton: Dr. Patton spent the first 16 years of his career in academia as a lipid biochemist and marine biologist. He then left to lead the drug delivery team at Genentech in 1985. Since then, he acquired extensive experience in biotech industry drug delivery startups, where he co-founded Inhale/Nektar Therapeutics, Dance BioPharm, InCarda, and iPharma Limited. He is now the CEO of Tesio Pharmaceuticals and the founding investor of Halozyme. Dr. Patton is a Fellow of the Controlled Release Society.

Mark Prausnitz: Dr. Prausnitz is a Regent’s Professor and J. Erskine Love, Jr. Chair in Chemical and Biomolecular Engineering at the Georgia Institute of Technology. He received a BS degree from Stanford University and Ph.D from MIT, both in chemical engineering. He has published more than 300 journal articles and has co-founded seven startup companies including Micron Biomedical and Clearside Biomedical.

W. Mark Saltzman: Dr. Saltzman is an engineer and educator who has been the sole author of three textbooks and has served as a faculty member at Johns Hopkins University, Cornell University, and Yale University. He is the founding chair of Yale’s Department of Biomedical Engineering and the Head of Yale’s Jonathan Edwards College. He has been recognized for excellence in research and teaching and has been the recipient of numerous awards and has been elected a Fellow of the American Institute for Medical and Biological Engineering, the Biomedical Engineering Society, and more.

Larry Zeitlin: Dr. Zeitlin received his doctorate in Reproductive Biology from Johns Hopkins University and served as a Research Scientist at ReProtect, and a Senior Scientist at Epicyte Pharmaceuticals. He co-founded Mapp Biopharmaceutical and ZabBio, and serves as President for both companies. His career focus has been on the development of monoclonal antibody based products to address unmet public health needs in infectious disease.

For more information on CMC Pharmaceuticals and members of the advisory board, please visit www.cmcpharm.com

 

About CMC Pharmaceuticals:
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:

Jared Heimovitz, Marketing & BD

CMC Pharmaceuticals

440-485-1734

jared.heimovitz@cmcpharm.com

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Stability Studies for Pharmaceutical Development
Date: January 19, 2022
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Understanding the purpose and objective of stability studies at each product development phase is critical in designing and executing appropriate stability studies for pharmaceutical development.

Dr. Mike Radomsky, President and co-founder of CMC Pharmaceuticals, has laid out the importance of conducting stability studies throughout the various stages of drug product development. Download the free white paper below to better understand the objective of these studies and when and why they are performed at different stages of drug product development. The team at CMC Pharma, along with Dr. Radomsky, are ready to help you navigate these critical studies and advance your program. CMC Pharma has current capacity to start work on your project right away–contact us today to schedule a call with a scientist.



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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:

 

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. 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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