Recent FDA Inspection Supports GMP Testing Services
Date: November 20, 2023
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Recent FDA Inspection Supports Offered cGMP Testing Services

CMC Pharmaceuticals recently had its first unannounced Pre-approval/General cGMP Inspection. The inspector concluded on 3-day (Sept. 2023) and observed no objectionable conditions as such no FORM 483 was issued. The center has classified the inspection as “No Action Indicated” and we anticipate receipt of the establishment inspection report shortly. This supports our current cGMP service offerings which include stability studies, release testing, development and validation of analytical methods, and more.

 

By offering GMP testing services, the data we generate in our laboratories can be used in regulatory filings. Regardless of what stage of development a drug product program is in, facilities that perform GMP testing provide a significant advantage and ensure reliability and credibility. Contract labs like CMC Pharmaceuticals can perform most of the required studies and analytical testing for drug product development programs. It is advantageous to select a lab that is a one-stop-shop and can perform not only early-stage formulation development but also method development and validation, GMP release testing, GMP stability studies, and more. This recent FDA inspection adds additional quality assurance to the type of work performed at CMC Pharmaceuticals.

 

At this time, CMC Pharmaceuticals cannot manufacture commercial cGMP drug product, but we can provide manufacturing process scale-up services as well as technology transfer services. Oftentimes, commercial manufacturers may not have the capacity to perform early-stage studies or may not have the deep formulation development expertise that CMC Pharmaceuticals can provide. That being said, choosing the right pharma development lab may not only expedite your drug product development program but can also save you money and headaches down the road. We are confident in our ability to support pharma development programs from early stages through commercialization and can even help you choose the right CDMO for manufacturing. Contact us today to learn more!

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CMC Pharmaceuticals Continues Development of Medical Countermeasures
Date: December 6, 2022
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CMC Pharmaceuticals Awarded Sequential Phase II SBIR Grant to Continue Pharmaceutical Development of a Medical Countermeasure to Nerve Agents

 

Solon, OH: CMC Pharmaceuticals has been awarded a Sequential Phase II Small Business Innovation Research (“SBIR”) grant from the U.S. Defense Department’s (“DoD”) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in collaboration with the Defense Threat Reduction Agency. The award funds the continued development of a promising medical countermeasure (“MCM”) for nerve agents that contain a stable, fixed-dose combination formulation of atropine and scopolamine.  

 

“This newly-awarded grant allows CMC Pharma to continue developing an MCM to protect our Service Members against nerve agents,” said Dr. Mike Radomsky, Principal Investigator and President of CMC Pharma. “We identified promising lead formulations in earlier SBIR grants and this award gives us the opportunity to expand on that work. Over the next two years, we will be performing proof-of-concept nonclinical studies and chemistry, manufacturing, and controls activities to ready the program for pre-IND discussions with FDA.  Additionally, we will identify an appropriate cGMP drug product manufacturing site for material needed for IND-enabling and clinical studies.”  

 

CMC Pharma recognizes the current and future threat of chemical and biological warfare to the warfighter. The objective of this program is to develop a combination drug product that is a stable and effective treatment for organophosphate nerve agent poisoning. A combined formulation of atropine and scopolamine could increase the therapeutic efficacy of the current treatment regimen while minimizing the logistical burden associated with carrying and administering a multi-drug MCM regimen. 

 

This development effort will bridge the gap between laboratory-scale innovation (i.e., CMC Pharma’s previous effort) and entry into an FDA regulatory pathway leading to commercialization.  CMC Pharma plans to execute future studies to support FDA approval of the drug product and secure the appropriate supply chain, with the vision of providing the drug product for DoD issuance to service members stationed in areas of Nerve Agent Threat Potential and supplying the Strategic National Stockpile.

 

CMC Pharma has successfully managed a wide variety of pharmaceutical development programs, including multi-year programs with the federal government. In addition, CMC Pharma possesses significant experience with scopolamine and atropine formulations. The continued development of this new combination product not only leans on existing expertise but helps to advance corporate strategy to provide world-class drug development services to the DoD to develop medical countermeasures to address threats to the warfighter.  CMC Pharma has a portfolio of MCM products for chemical defense funded by DoD and is seeking development, manufacturing, and commercialization partners for this chemical defense MCM portfolio.  

 

The contract number for this grant is W911SR22C0047.

 

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

 

About CMC Pharmaceuticals:

 

CMC Pharmaceuticals (CMC Pharma) is a leading provider of drug product development services and manufacturing support to the pharmaceutical and biotechnology industries.  CMC Pharma delivers 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 Pharma offers decades of specialized scientific experience in the development and manufacture of a wide range of drug product types including sterile injectables, solid oral, 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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PODD: Partnership Opportunities in Drug Delivery – 2022 Conference Recap
Date: November 16, 2022
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After a long couple of years and many virtual conferences, the team at CMC Pharma is back on the road. Mid-2022 we took a trip up north to Montreal for the Controlled Release Society’s Annual meeting. Then, this October, we traveled to the PODD (Partnership Opportunities in Drug Delivery) Conference in Boston. It was great to reconnect face-to-face with old colleagues and industry partners and make new connections during the course of the two-day event.

The organizers of the conference put care into the program and layout of the show. There were many great speakers and the talks were well-attended. Mike Radomsky, President of CMC Pharma, gave a presentation on day 1 to shed light on CMC’s experience designing drug delivery systems.

Radomsky spoke about how long-acting therapy can be achieved from a single injection by utilizing in situ forming depots. CMC Pharma routinely formulates PLGA and other polymer implants and formulations for controlled-release drug delivery applications. Benefits include its simple manufacturing process and low cost-of-goods, an opportunity to create IP for API or indication-specific drug products since the core technology is off-patent, and that the formulation technology and excipients are proven to be effective and are utilized in existing FDA-approved products.

CMC is proud to provide drug product development services to the pharmaceutical industry. In addition to our expertise in designing drug delivery systems, our lab is well-equipped to help transform your innovative ideas into approved products. The scientists at CMC routinely develop and validate analytical methods, perform pre-formulation and formulation studies, run ICH Stability and compatibility studies, and prepare drug product products for in vivo and in vitro studies. CMC Pharma’s capabilities and services are appropriate for programs from early to late-stage development through FDA approval and commercial launch. As a preferred partner for contract lab services, our number one goal is to keep your development program on track.

If you missed Mike Radomsky’s Presentation at PODD 2022, a copy of the slides can be downloaded here:

 

 

 

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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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