GHP Q3 2021

46 GHP / Q3 2021 GHP / Q3 2021 47 , , Jul21181 Efficient CDMO Services Chime Biologics provides client-centric and cost-effective services for timely premier-quality biopharmaceutical development andmanufacturing. The Chime single-use facility supplies drug substances and drug products tomore than 20 countries and is compliant for all major markets including US, Europe and UK. It also supports clients looking for a strategic local partner for the Chinamarket. Named Best Contract Development andManufacturing Organisation 2021 – China by Global Health & Pharmamagazine, we profile the company to find out more. Chime Biologics is a world-class contract development and manufacturing organisation (CDMO) that has delivered more than 30 programmes compliant with FDA, EMA, NMPA, and more than 20 other regulatory authority requirements. It is proud of its record for quality, compliance, bioprocessing expertise, and cost-effectiveness. The experienced team has successfully delivered CMC, DS and DP process development and GMP manufacture programmes including mAb, bsAB, fusion proteins, and conjugated proteins, and they are available to discuss how best to support priority programmes. Most biotechs do not have their own process development and manufacturing capabilities and will outsource to development and manufacturing partners. Chime has several clients operating a virtual model, as well as multiple clients using its facilities as additional capacity, either for drug substances, drug products, or both. In some cases, clients use Chime’s services to supply specific markets and to de-risk their supply chain. Chime began operating its current state-of-the-art facility in 2013 and during its construction, built a core senior team with international experience in biologics process development and manufacture. This included process and analytical testing and characterisation experience as well as quality and regulatory function experience. Within the last 18 months, Chime’s staff have adjusted to remote working, since travel was impacted throughout the world due to the COVID-19 pandemic. This was done using technology such as Microsoft Teams and Zoom for remote site tours, technical and quality audits, and to allow remote person in plant where possible. COVID-19 has been the focus of many companies for vaccine and therapeutic product development. The majority of these processes are reliant on single-use technology, making supply a potential constraint to development timelines. Chime has supply agreements with major single-use suppliers and has invested heavily in critical inventory to have immediate availability. Chime has also developed back-up single-use suppliers as a contingency to maintaining critical programme milestones. Chime recently signed a commercial manufacturing agreement for a potential COVID-19 therapeutic to supply global markets outside the US. Other clients have come to the company for development of products that are not for COVID-19 but need to be transferred out from internal capacity or from other CDMOs in order to keep momentum in multiple programmes in parallel. In this short term, this trend is likely to continue and Chime wants to offer support for development where a process has yet to be established or for GMP manufacture where a process already exists. Meanwhile, Chime has a number of exciting plans ahead. Firstly, it has started construction of its GMP-2 facility on its existing site. This is in direct response to capacity demand for clinical and commercial manufacturing capacity. This includes expansion of its MSAT capacity to support process characterisation and process qualification activities. Also, Chime is investing in a new bioprocess innovation centre which will formalise its research and development process and expand its capabilities for this function. Alongside this, it has launched The Chime Innovation Center to address a client need for cell line engineering and development. Many of its existing clients already have cell lines at MCB stage when Chime begins collaboration, however some collaborators need a new cell line to produce a new product for development or want to change to a more productive cell line before late stage development. Finally, chime has announced the expansion of commercial manufacturing capacity on a new bigger site. This will ensure it can scale up and grow with its existing clients and have capacity for new clients who need manufacturing capacity supply or for local support in China. Company: Chime Biologics (Wuhan) Co. Ltd Contact: Vincent Liu Email: [email protected] Website: Jul21036 Protecting the “Things” that Protect Human Lives CyberMDX is an IoT security leader dedicated to protecting the delivery of quality healthcare worldwide. Founded in 2017, its mission is to enable healthcare delivery organisations worldwide to provide quality care by securing and protecting the systems and devices they rely on every day to treat illnesses and save lives. Global Health & Pharmamagazine has recognised CyberMDX’s dedication and hard workwithin the healthcare sector by naming the company Leading Provider of Innovative Healthcare Delivery Security Solutions 2021. We take a look at how its solution is revolutionising cybersecurity in healthcare delivery organisations. Healthcare delivery has more security challenges than most sectors. Facing a constant combination of cybercriminals, nation-state actors, hacktivists, and malicious insiders, the need for strong defence of all devices on managed or unmanaged networks is paramount. CyberMDX’s solution focuses on global hospitals and healthcare delivery organisations which have connected medical, IoMT, and IoT devices on their networks. Connected medical devices have no security built into them and are not likely to be visible to native IT control systems. As a result, many hospitals don’t know how many medical devices (managed or unmanaged) are connected. They also don’t have data on the type of medical device, its location, or its true cybersecurity risk status. Worse yet, there is hardly any visibility to whether medical devices have already been hacked. Medical devices introduce a wide range of operating systems and communication protocols and current cybersecurity solutions do not fully understand these devices or their protocols and cannot provide adequate security. The CyberMDX Healthcare Security Suite focuses on IoT, IoMT, medical devices, and assets connected to clinical networks, providing complete visibility and network protection by leveraging CyberMDX’s expertise with Artificial Intelligence (AI) technology, medical device vulnerability research, and a wide range of cyber capabilities. The CyberMDX solution detects and evaluates potential threats by implementing security at four layers:asset inventory and tracking, risk assessment and preventative care, detection and response, and compliance and governance. At the core of the CyberMDX solution is aunique approach to medical device security – Device- Centric Risk Management (DCRM). CyberMDX provides on-going risk assessment of all connected assets including vulnerability and compliance profiles. The solution offers a prioritised list of asset groups and recommended actions to remediate or mitigate the risks associated with these assets on three distinct protection layers: on-device, on-network, on-perimeter. This is inherently more robust than other solutions which focus their security and risk management solely on the network layer. The Chief Information Security Officer of Israel’s largest private hospital network said, “CyberMDX’s solution was deployed in all eight Assuta hospitals and medical centres. The unique technology enables us to control and manage the security of thousands of connected devices within the network, as well as prevent in advance cyber-attacks from happening.” During the pandemic CyberMDX saw the challenge of ensuring that hospital staff didn’t take time away from addressing pandemic-related issues. Teams proactively worked to educate health delivery organizations and help them mitigate the threat of a possible breach which could further impact operations. During that time, there was a dramatic increase in attempted cyberattacks and the focus on containing the virus and securing public safety had inadvertently opened the path for cybercriminals. The threat landscape now continues to evolve. CyberMDX will help hospitals detect and mitigate attacks which seem likely to grow in frequency and sophistication. In addition, the company’s Vulnerability Research and HTM Analysis team will continue working closely with medical device manufacturers, security vendors, and regulatory organisations (e.g. CISA, FDA, MITRE) for the responsible disclosure of security vulnerabilities, which enable CyberMDX to offer the best protection possible against the ongoing cyber threat against healthcare delivery organisations. Company: CyberMDX Contact: Rich DeFabritus Email: [email protected] Website: