Due to the high volume of interest in the cold chain validation best practices topic, Modality Solutions is providing free on-demand replays of the informative 45-minute webinar.

With more than 35 international cold chain regulatory compliance guidance documents, global standards are becoming more comprehensive and increasingly complex,” said President, Gary Hutchinson. “Our webinar is positioned to help companies build their reputation of reliability with regulators.”

HOUSTON (PRWEB)
November 22, 2019

Modality Solutions, biopharmaceutical cold chain engineering firm, hosted a live webinar covering a step-by-step cold chain validation guide to meet and exceed increasingly stringent regulatory expectations including monoclonal antibodies, antibody-drug conjugates, and cell therapies. Targeting complex cold chain biopharmaceutical industry leaders, the September 19, 2019 webinar was well received and attended. Due to the high volume of interest in the topic, Modality Solutions is providing free on-demand replays of the 45-minute presentation. Click here to access the cold chain validation webinar.

Modality Solutions’ principals Gary M. Hutchinson and Daniel J. Littlefield presented the webinar entitled “Cold Chain Validation Best Practices Including Immunotherapy” in conjunction with Pharmaceutical Technology and Business Review Webinars.

Modality Solutions has access to the latest regulatory agency requirements for emerging therapeutics. Personalized therapies employing ADC (Antibody Drug Conjugates) and CAR T-cell (Chimeric Antigen Receptor T-cell), have complex cold chains. This difficulty presents challenges in the transportation, chain of custody, traceability, and storage of the cells, which creates a significant risk in the treatment process. New validation approaches based on regulatory responses to previously submitted immunotherapy cold chains are shared in the webinar.

Four of the valuable webinar learning objectives include:

• How to integrate stability data and testing for environmental hazards during transport of a drug product into a validation master plan for cold chain distribution.
• How to qualify your transport lanes with an operational and performance qualification approach.
• Why ASTM D4169 is no longer enough – with examples of drug product testing for distribution vs. packaging qualification testing.
• How to put all of the above together for filing and inspection.

“With more than 35 international cold chain regulatory compliance guidance documents, global standards are becoming more comprehensive and increasingly complex,” said Modality Solutions President, Gary Hutchinson. “New therapies, accelerating costs, sustainable technologies, and emerging markets demand validated cold chain networks that consistently produce low-cost and high-quality outcomes for patients–with a minimal variation, delivering value to a company’s supply chain. Our webinar is positioned to help companies build their reputation of reliability with regulators.”

Business Review Webinars (BRW) is a thought leadership portal for business professionals in the pharmaceutical, healthcare, food & beverage, energy, packaging, supply chain, and technology industries. Its goal is to create a high-level discussion between industry thought leaders and business professionals who are actively facing the day-to-day challenges of their respective industries. Topics are based around an editorial plan established by leading editors and analysts.

To access the on-demand replay of “Cold Chain Validation Best Practices Including Immunotherapy” go to https://modality-solutions.securechkout.com/cold-chain-validation-best-practices-webinar

To learn more about Modality Solutions visit https://www.modality-solutions.com.

About Modality Solutions, LLC

Founded in 2011, Modality Solutions, a biopharmaceutical cold chain engineering firm, specializes in integrating cold chain operations, developing transport validation strategies, supporting global regulatory applications, and supporting global clinical trial operations. By combining the best practices of process validation, systems qualification, and risk assessment, Modality Solutions has earned the reputation of ensuring regulatory compliance, product quality, and patient safety. As a 2019 Inc. 5000 company, Houston Business Journal Fast 100, Entrepreneur 360™, and Forbes Technology Council company, Modality Solutions’ team of engineers are experts at delivering cold chain thermal packaging design and qualification, conducting transport simulation testing with its Advantage Transport Simulation Laboratory™, and designing controlled-environment logistics solutions. For more information, visit https://www.modality-solutions.com.

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Livingston Place at Southern, Washington, DC

“We are excited to deliver the first affordable assisted-living facility to Ward 8, ensuring that seniors will be able to continue living in the community they love,” said Mayor Muriel Bowser.

WASHINGTON (PRWEB)
November 22, 2019

Today Mayor Muriel Bowser, the District of Columbia Housing Finance Agency (DCHFA), and the project development team comprised of Dantes Partners, Gilbane Development Company, Carding Group, and H Street Community Development Corporation (HSCDC) celebrated the groundbreaking of Livingston Place at Southern, the first assisted living facility in Ward 8 and only the second with its services in the District. The five-story, 152-unit affordable community is reserved for seniors age 60 and above who require assistance with two or more activities of daily living. Residents of Livingston Place at Southern will receive meals, personal care services, and transportation services.

Apartments at Livingston Place at Southern will be reserved for individuals or couples with incomes of 60 percent or less of the annual median income and residents who qualify for Medicaid.

“We are excited to deliver the first affordable assisted-living facility to Ward 8, ensuring that seniors will be able to continue living in the community they love,” said Mayor Bowser. “Through investments in communities like Livingston at Southern, we’ll keep providing safe and affordable places for those who have helped build this city and earned the right to age in place.”

“The Gilbane Development Company/Dantes Partners team is thrilled to usher in the first affordable assisted housing in Ward 8 for our aging seniors,” noted Buwa Binitie of Dantes Partners, joint venture developer for the project. “And we could not have done it without our dedicated partners at DCHFA, the DC Department of Health and the Department of Healthcare Finance.”

DCHFA issued $50 million in bond financing and underwrote $15.3 million in low-income housing tax credit (LIHTC) equity for the construction of Livingston Place at Southern, a $67 million development that will consist of 84 efficiency and 68 one-bedroom apartments. “Livingston Place at Southern is a unique development that will provide assisted living services to senior citizens that are capable of living independently yet need help with daily care. The property will provide an option for District seniors to be able to age in place in an affordable community with support services onsite,” stated Todd A. Lee, Executive Director and CEO, DCHFA.

The property management company will be licensed by the DC Department of Health to operate the development as an assisted living facility. Staffing at the property will consist of an executive director and medical staff including a full time Director of Nursing, Licensed Practical Nurses eight hours a day and certified nurse’s aides and trained medication employees on‐duty 24 hours a day.

All tenants will have access to support services including medical, dental, rehabilitative, and counseling services; assistance with activities of daily living, including eating, bathing, toileting, grooming, dressing and mobility, and 24‐hour supervision to ensure resident safety. Eleven percent of the apartments are designed to be fully accessible. All units throughout the building will feature accessibility measures such as lower kitchen countertops, spacious bathrooms with grab bars and an emergency call system. The development will feature common amenities such as a club/community room, dining rooms, library, theater/TV center, fitness/wellness center, beauty/barber salon and transportation for off-site activities.

The District of Columbia Housing Finance Agency is in its 40th year of serving Washington, D.C.’s residents. The Agency’s mission is to advance the District of Columbia’s housing priorities; the Agency invests in affordable housing and neighborhood development, which provides pathways for DC residents to transform their lives. We accomplish our mission by delivering the most efficient and effective sources of capital available in the market to finance rental housing and to create homeownership opportunities.

Gilbane Development Company is the project development, financing, and ownership arm of Gilbane, Inc., a private holding company in its fifth generation of family ownership and management. Gilbane Development Company provides a full slate of real estate development and project management services. Completed projects incorporate every aspect of real estate including: affordable housing, student housing, multifamily and single-family residential communities, mixed-use developments, corporate headquarters, healthcare facilities, operational | data | distribution centers, R&D | manufacturing facilities, and many types of facilities delivered through public-private partnerships. To learn more, visit http://www.gilbaneco.com/development

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