PHARMA TECH
PR Newswire | January 25, 2024
SHL Medical, a world-leading solutions provider of advanced drug delivery systems and SteriPack Group, renowned global supplier of secondary packing and final assembly services to the pharmaceutical industry, enter a non-exclusive strategic partnership. Together, they aim to establish a pre-validated final assembly service at the SteriPack facility in Poland, enhancing the overall flexibility of supply chain strategies for their customers. In addition to SHL Medical's existing final assembly, labeling, and packaging¬ services in the United States, this collaboration extends high-quality CMO options to Europe.
Markus Puusepp, SHL Medical's Chief Growth Officer, expressed enthusiasm about the partnership, stating "This partnership is a significant addition to the Molly platform value proposition. We share common values with SteriPack, from focus on the customer to a commitment to quality, making the decision to collaborate straightforward."
Recognizing the importance of flexibility and time-to-market, especially in clinical production, the partnership with SteriPack will offer SHL Medical's customers highly flexible and personalized final assembly and packaging solutions. This is particularly beneficial for small batch handling in clinical supply and niche markets like rare diseases. Emphasizing the comprehensive capabilities of the Molly platform, SHL Medical aims to deliver right-sized solutions that ensure improved service, faster timelines, and a more streamlined supply chain for its diverse customer base.
John Ward, SteriPack Group's VP Pharmaceutical Solutions commented "SteriPack Group looks forward to supporting SHL Medical and their customers in providing quality and flexible solutions to a fast- moving market. With an emphasis on creating service solutions designed around specific customer requirements, this partnership will make the process of working with the Molly platform an easy decision."
About SHL Medical
As a world-leading solutions provider of advanced drug delivery systems, SHL Medical is the partner of choice for many leading pharma and biotech companies. Driven by its company purpose – Enabling Patients' Independence – SHL Medical offers patient-centric solutions for the design, development, and manufacturing of autoinjectors, pen injectors, as well as innovative specialty delivery systems for large-volume and high-viscosity formulations. It also offers final assembly, labeling, and packaging solutions for its drug delivery systems.
In response to the rising trend in home therapy, SHL Medical has increased its developmental work in the digital healthcare sector to help improve the drug delivery ecosystem.
Located across Switzerland, Taiwan, Sweden, and the US, SHL Medical's global team of experts collaborate seamlessly as one team in utilizing its comprehensive in-house manufacturing capabilities. Its solutions offer customization and optimization for each project while proactively weaving sustainability-driven measures into its designs and processes to contribute to a cleaner earth.
About SteriPack Group
SteriPack Group is a globally renowned contract packing and manufacturing organisation serving the pharmaceutical and medical device sectors respectively. With a strong emphasis on innovation, quality and compliance, SteriPack's services to the pharmaceutical industry include device design and development, final assembly, labelling, secondary packing, serialisation and aggregation of injectable formats including vials, pre-filled syringes, and autoinjectors.
SteriPack's tailored customer-focused solutions make it an ideally suited supplier for small to medium-sized batch volumes required for a growing market of targeted therapies as well as clinical trials. Its proven capabilities in cleanroom assembly and labelling as well as secondary packing services for drug delivery systems and medical devices, combined with significant investment into growing cold chain storage capacity, have helped to make it a trusted partner to top global pharmaceutical companies.
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PHARMA TECH
PR Newswire | January 09, 2024
Flagship Pioneering, the bioplatform innovation company, and Samsung today announced a collaboration aimed at fostering cutting-edge biopharmaceutical innovation poised to transform the world of healthcare through groundbreaking advancements in translational science and medicine.
Through this collaboration, Samsung will work alongside Flagship-founded companies, leveraging Samsung's leading technologies and capabilities to accelerate first and best-in-class therapies. The newly formed strategic partnership is an expansion of the ongoing cooperation between Samsung and Flagship. The collaboration between Samsung and Flagship leverages the expertise of both organizations in the areas of life science technology, artificial intelligence, and CDMO services, and extends across Flagship's ecosystem of companies.
Key Highlights of the Collaboration:
Revolutionary Technology: The collaboration will leverage state-of-the-art technology including artificial intelligence, translational medicine, access to high quality clinical samples and Samsung's clinical trials infrastructure, and investment by Samsung in Flagship-founded companies.
Shared Vision: Flagship Pioneering and Samsung share a common vision of transforming conventional drug discovery and development approaches to help bring new targeted therapeutic solutions to patients. The collaboration is driven by a commitment to pushing the boundaries of what is possible in the bio-pharmaceutical industry.
"This collaboration represents a significant milestone in the pursuit of innovation and scientific excellence," said Stephen Berenson, Managing Partner, Flagship Pioneering. "As partners, we will bring together Flagship Pioneering's unparalleled expertise in inventing and developing revolutionary bioplatform companies with Samsung's strategic capabilities to reshape and empower the bio-pharmaceutical landscape, ultimately resulting in bigger leaps for patient care."
"This newly formed collaboration is an important evolution of the ongoing relationship between two companies," said Jaywoo Kim, executive vice president, Samsung C&T. "We look forward to seeing the accelerating effect of Samsung's various technical expertise and extensive commercial capabilities on the future innovations Flagship and its ecosystem of companies will bring to market."
About Flagship Pioneering:
Flagship Pioneering is a biotechnology company that invents and builds platform companies, each with the potential for multiple products that transform human health or sustainability. Since its launch in 2000, Flagship has originated and fostered more than 100 scientific ventures, resulting in more than $70 billion in aggregate value. To date, Flagship has deployed over $3.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $27 billion of follow-on investments from other institutions.
About Samsung C&T:
Samsung C&T Corporation, a dynamic player in industries ranging from construction, trading, fashion and resorts, is actively expanding its portfolio with strategic investments in the biopharmaceutical industry. Since its investing in Samsung Biologics and Bioepis, Samsung Biologics' CDMO production capacity has grown to over 600 kilo liters and contribute greatly to the stabilization of the biopharmaceutical supply chain. In addition, Samsung Bioepis has improved the accessibility of many patients around the world by successfully launching seven biosimilar products. Samsung C&T will continue investment in innovative technologies and businesses that contribute to 'improving quality of life' in various areas of bio & healthcare.
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PHARMA TECH
PR Newswire | January 24, 2024
ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), and Performance Validation, Inc. a 100% employee-owned company serving the life sciences industry since 1988, have partnered to deliver unique compliance-focused digital validation solutions for life sciences companies in the US.
Performance Validation is an industry leader with over 30 years of experience in analyzing, identifying, and testing the most critical elements of the manufacturing process for FDA-regulated industries. The company provides environmental mapping, commissioning, qualification, computer system validation, and quality system consulting services.
ValGenesis is the industry innovator of digitized validation. The company's platform, which includes its flagship VLMS offering, is used in over 100,000 GMP systems worldwide, helping life sciences companies advance their digital transformation strategy, enforce compliance, and enable standardization with 100% digital, risk-based validation software.
In this partnership, Performance Validation will implement and manage next-generation digital validation tools developed by ValGenesis, including ValGenesis VLMS and VLMS Express, a simplified cloud-based digital validation solution for startups and midsized companies. ValGenesis and Performance Validation are providing an integrated governance approach to further strengthen risk and compliance across their customers' manufacturing processes.
"We are excited to partner with Performance Validation. Their extensive experience and our industry benchmarked digital validation platform can help life sciences companies implement their digitization plans efficiently according to Industry 4.0 standards," says Bo Olsen, ValGenesis' SVP of Partners. "By establishing a clear strategy that addresses their risk and compliance implications upfront, we can assure them of true business transformation."
"Performance Validation is thrilled to embark on this collaborative journey with ValGenesis, leveraging our extensive experience and knowledge of digital validation solutions. It's a powerful combination – our hands-on validation experience and their innovative digital tools. For our clients in the life sciences, this means more efficient, streamlined, and compliant solutions. We're not just adapting to Pharma 4.0; we're helping our clients lead the way in digital transformation," says Brad Henry, Vice President of Service Lines at Performance Validation.
ABOUT PERFORMANCE VALIDATION
Performance Validation (PV) is a global validation partner for pharmaceutical and medical device manufacturers. Headquartered in Indianapolis, IN, we specialize in turning compressed timelines into compliant ones using innovative, adaptive approaches that balance production realities with strict regulatory requirements. Our best-in-class, cGMP-compliant services cover diverse needs from fully managed CQV to on-demand temperature mapping, smoke studies, software assurance, and more. With a dedicated team consisting of more than 95% engineers, we work closely with regulators and equipment suppliers to keep validation ahead of production curves and keep quality moving forward.
ABOUT VALGENESIS
ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life sciences companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process. This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.
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