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.
PR Newswire | January 09, 2024
DotLab, a medical diagnostics company, announced top-tier pharmaceutical research clients for its DotEndo platform. The customers include global companies with interests in diagnosing or monitoring endometriosis on a Research Use Only basis in clinical trial subjects to support the development of new medicines.
"We're proud to share the news of our global pharmaceutical partners, which are complementary to our planned, large clinical offering for commercial endometriosis tests based on our technologies," said DotLab's founder, Heather Bowerman. "Our pharma partners conducted rigorous diligence of our science and intellectual property prior to the execution of our contracts, and they view our platform as the first of its kind and the leader in this space."
The DotEndo™ platform's AI/ML technology was developed via DotLab's EMPOWER clinical trial, a prospective, observational, multi-center study run at endometriosis centers of excellence across the United States. EMPOWER is the most robust clinical study of its type ever performed for diagnosing and monitoring endometriosis, making it an excellent foundation for the platform. Based on these successes, DotLab announced Morgan Stanley as a new investor in late 2023.
"We intend to continue to offer our pharma clients – and, ultimately, clinicians – a comprehensive endometriosis menu of tests and tools. Endometriosis is notorious for its complex biology, and there has long been a need for tests and tools to diagnose and monitor endometriosis – and ultimately, to improve endpoints for the disease in therapeutic trials," said Bowerman.
Dot Laboratories, Inc. ("DotLab") is solving some of the world's most significant diagnostic challenges via the latest advancements in multiomics and computational biology. The company delivers clinical innovations to areas of significant unmet need via novel, cutting-edge biomarkers and the power of machine learning to deliver non-invasive tests. The company has driven a paradigm shift in the identification and management of endometriosis. DotLab is female-founded and female-led.
PR Newswire | January 03, 2024
ValGenesis, Inc., the market leader in enterprise validation lifecycle management systems (VLMS), today announced that a leading Spanish pharmaceutical company selected ValGenesis VLMS – the industry's most trusted electronic validation lifecycle management system – to digitize its corporate validation process.
Founded in Spain over eight decades ago, the company focuses on developing over the counter (OTC) drugs and products. Since then, it has grown its production to include prescription (RX) drugs and launched its first generic product on the Spanish market.
The company's decision to transition from conventional paper-based methods signifies its move toward 100% digital operations, marking a new era in efficiency and traceability in manufacturing operations. The ValGenesis VLMS provides an all-encompassing digital solution to fully manage their validation lifecycle, ensuring accuracy, data integrity, and compliance with worldwide regulatory standards.
"We are pleased to onboard our first Spanish customer and first partner deal in the region," says Steve Reynolds, Chief Revenue Officer at ValGenesis. "This win represents a step-change in the way ValGenesis and its partners collaboratively address the industry's needs. We look forward to helping our customer leverage cutting-edge digital validation technology on their path to digital transformation, balancing speed with strict adherence to regulatory compliance."
ValGenesis, Inc. is the creator of an innovative software platform that is a foundation for managing compliance-based validation activities in life science 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.