Microbiology Research Associates Appoints New Director of Business Development

Acton, MA – Microbiology Research Associates (MRA) (http://www.mra-bact.com) recently announced that Kelly Hagen has joined the team to develop their growing portfolio of regional and national accounts further. Kelly Hagen comes with a wealth of knowledge and experience within the Industry. For the past five years, Kelly has been responsible for selling high-value chemistry development and manufacturing services for API, Intermediates and Raw Materials to C-Suite Level Executives and Scientists within the pharmaceutical and biotechnology industry.

Before her work in Business Development, Kelly spent ten years working in the pharmaceutical industry with positions at Sunovion, Novartis and Purdue Pharma.

Kelly holds a Bachelor of Arts in Communication Sciences Degree from the University of Connecticut.

Kelly comments “I am excited to start a new challenge with Microbiology Research Associates, the leader in the on-site environmental monitoring of hospital compounding pharmacies In the New England area and I look forward to working with the team to further develop the regional and national presence.”

Darcy Sidwell, Vice President “Kelly brings a wealth of business development experience and will be an asset to our fast-growing Microbiology Testing and Consulting Laboratory Services Company.”

Contact Information:
Microbiology Research Associates
Kelly Hagen
203-685-7919
Email:Kelly@mra-bact.com

About Microbiology Research Associates:
Microbiology Research Associates (MRA), offers microbiology consulting, research and testing services to the pharmaceutical, cosmetic, medical device, biotechnology, and health care industries. MRA is an FDA (No# 1000148174) and DEA (No# RB0486096) registered laboratory and has state of the art ISO 5 Cleanroom with Isolator.

Microbiology Research Associates
978-263-2624
info@mra-bact.com

MRA ANNOUNCES THE ADDITION OF A NEW CUSTOMIZED MICROBIAL TESTING PROGRAM FOR 3D INK PRODUCTS.

MRA’s 3D ink program is able to detect and quantify the amount of potential microbial contamination within an ink product.  This testing also determines shelf life capabilities in order to prevent microbial proliferation within the ink.

  • Detecting and quantifying – USP <61><62> bioburden test which will determine total number of bacteria yeast and mold as well as the absence of specified pathogens.
  • Shelf life capabilities – USP <51> Antimicrobial Effectiveness Test which will determine the efficacy of the preservative characteristics of the product.

MRA’s President, Fran McAteer to be Keynote Speaker

Fran McAteer, MRA’s President, will be a keynote speaker at the Yankee Alliance GPO annual meeting on May 2nd, 2017. He will be presenting the proposed USP <797> revisions for the member audience. Fran initiated a first-in-the-nation program for USP <797> compliance assessment of third party high risk compounders.  He also introduced a compliance program for registered compounders to meet the standards of the recently passed Drug Quality & Security Act.

MICROBIOLOGY RESEARCH ASSOCIATES, INC. (MRA) OFFERS USP <797>, USP <1207> & PDA TR N0. 27 CONTAINER CLOSURE INTEGRITY TESTING

Parenterals, high risk or proposed USP <797> Sterile Compounding, Category 2 compounds can be tested for container closure integrity to demonstrate sterility and stability. Container Closure Integrity testing for USP <1207> Sterile Product Packaging Integrity Evaluation is performed per PDA (Parenteral Drug Association) Technical Reference (TR) No. 27 Pharmaceutical Package Integrity. Testing utilizes high density microbial challenges of Brevundimonas diminuta, a very small rod shaped organism, for penetration to the container closure seal. Failure of microbial penetration into the container is the acceptance criteria for demonstration of closure integrity. This type of testing is the basis of stability verification in parenterals and also Beyond-Use-Dating (BUD) extension in Compounded Sterile Preparations (CSPs).

MRA has performed container closure integrity testing on vials, syringes, large volume parenterals and IV bags for customers nationwide. Integrity testing is protocol based and utilizes microbial immersion methodology.

For more information email us at info@mra-bact.com.

MRA announces the addition of a new, comprehensive pharmacy program for Bacillus Calmette Guerin (BCG) compounding for Bladder Cancer Therapy

This state of the art program will complement the existing USP <797> and <800> services currently offered by MRA with emphasis on:

  • TICE® / TheraCys® BCG Mycobacterium bovis specific sampling and detection for air and surfaces in addition to existing USP <797> monitoring for viable particulates.
  • Personalized education and proficiency testing specifically designed for BCG compounding pharmacy personnel which includes organism handling and storage, aseptic technique and appropriate biohazard personal protective equipment (PPE).

Bacterial Endotoxin Testing

lal-test

 

Microbiology Research Associates adds the highly accurate Lonza Kinetic ELx808LBS Absorbance Plate Reader for added responsiveness in Bacterial Endotoxin Testing utilizing:

  • Kinetic Chromogenic Assay
  • Kinetic Turbidimetric Assay

Standard Gel Clot Method* is also available.

All testing meets the requirements outlined in USP <85>, USP <797>, ANSI/AAMI ST72:2011, EP 2.6.14 and the FDA Guidance for Industry Pyrogen and Endotoxins Testing.

*Note: For current clients wishing to move products from gel clot to the kinetic method, revalidation of the test method will be required.

 

Please contact Chris Tamburrini at 978-263-2624 or

Chris@mra-bact.com for quote.

 

MassBio CRO/CMO Symposium

Visit us at the MassBio CRO/CMO Symposium

https://www.massbio.org/events/signature-events/cro-cmo-symposium-43535

Thursday, December 8th

12 p.m. to 6 p.m.

Marriott Boston Cambridge

50 Broadway, Cambridge, MA

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Thompson Street Capital Partners and its Portfolio Company, Microbiology Research Associates, forms a new partnership through an acquisition of Accuratus Lab Services

ST. LOUIS (August 30, 2016)- Thompson Street Capital Partners (TSCP), a private equity firm in St. Louis with $1.5 billion of assets under management, has announced today that it has partnered with management and its portfolio company, Microbiology Research Associates (MRA) to acquire Accuratus Lab Services (Accuratus), the leading service provider to the developers, manufacturers, and users of antimicrobial products. Accuratus was purchased from Avista Pharma Solutions, Inc., a Contract Development and Manufacturing Organization (CDMO) with facilities in Durham, NC; Longmont, CO and Agawam, MA.

Based in Acton, MA, outside of Boston, MRA (www.mra-bact.com) is a leading provider of customized, microbiology testing services with expertise in current Good Manufacturing Practices (cGMP), United States Pharmacopeia (USP) testing for sterile and non-sterile product as well as Drug Quality and Security Act (DQSA) compliance for hospital pharmacies and compounding facilities. MRA is an FDA-registered contract laboratory specializing in product testing, validation and contamination control remediation for Biopharma, Medical Device, Pharmacy and Cosmetic companies. Thompson Street Capital Partners acquired MRA in May 2015.

mraHeadquartered in Eagan, MN, outside of St. Paul, Accuratus (www.accuratuslabs.com) is the leading provider of microbiology, virology, and analytical chemistry GLP testing services to ensure compliance with registration standards for the developers and manufacturers of EPA-regulated antimicrobial and consumer products. In addition, Accuratus helps companies in the medical device and biopharmaceutical industries with method development and validation of  cleaning, disinfection and sterilization procedures.

Following the closing of the transaction, Accuratus’ lab facilities will remain in Eagan, MN, and MRA’s lab facilities will remain outside of Boston.

Fran McAteer, President of MRA said, “MRA is pleased to partner with Accuratus and looks forward to expanding and integrating both companies services to provide leadership and further our expertise in microbiological contamination control. With patient care and infection control issues at the forefront of today’s society, growth in disinfectants, preservatives, sanitizers and new antibiotic research is accelerating and this partnership will have the capabilities to meet these challenges.”

Said Alan Roth, General Manager of Accuratus, “This acquisition strengthens our ability to service  our core antimicrobial customers while further diversifying our business service offerings to include new industries. We feel confident this transaction will create a powerful partnership between two leading microbiology labs and are thrilled to partner with MRA’s team of passionate and talented professionals.”

Fairmount Partners (www.fairmountpartners.com), an investment banking firm based in West Conshohocken, PA advised Accuratus; Sidley Austin LLP’s Chicago office (www.sidley.com) and Nolan & Associates (www.nolanassoc.com) based in St. Louis, MO advised MRA.

Combating Antibiotic Resistant Bacteria

Photo for Combating Antibiotic etc.

Combating antibiotic resistant bacteria is tantamount to the future quality of patient care on a global basis.

Superbugs with multidrug resistance (MDR) are increasingly wide spread in both hospital acquired infections (HAI’s) and public health outbreaks. MRSA, VRE & C. diff are just a few types that strike fear in the general population. With recent legislation, such as the PATH ACT and HHS initiatives like CARB-X, new antibiotic development is being accelerated.

Microbiology Research Associates (MRA) has assisted in recent new antibiotic development projects specifically designed to combat these organisms for various Biopharma clients. In our role, we have provided microbial technical expertise to support efficacy testing primarily targeting susceptibility testing, sample characterization and method validation.

Our antibiotic experience has been with:

  1. Short chain amino acids (aka defense mimetics)
  2. Monobactams
  3. Extended Spectrum beta-lactamase inhibitors (ESBL)
  4. Daptomycin Derivatives
  5. Lipopeptides inhibitors
  6. Combination Products

These cutting edge technologies for combating antibiotic resistant bacteria (CARB) are difficult to achieve with microbiology testing which are dependent on recovery specifications to verify test method validation.

MRA has successfully accomplished this and has established compliant USP compendial testing for the following regulatory specialties:

  • <51> Antimicrobial Effectiveness Testing
  • <61> Microbial Examination of Nonsterile Products (Microbial Enumeration Test)
  • <62> Microbial Examination of Nonsterile Products: Tests for Specified Microorganisms
  • <71> Sterility Testing
  • <85> Bacterial Endotoxin Testing

The aforementioned methods combined with Kirby Bauer disk diffusion and minimum inhibitory concentration (MIC) analysis provide verification and validation of susceptibility and lethality. In this way, MRA demonstrates the new antibiotic effectiveness and overall product quality which is a major acceptance criteria for regulatory compliance.

 

Please let us know if MRA can be a partner in your new antibiotic development program.