Discovering new compounds, bringing them through the approval process and finally having a product that can transform lives is one of the most rewarding occupations in the world. Ensuring that the investment in time and money is not lost through poor supply chain planning and execution is no small task however. The team at New Creed have supported many pharmaceutical and biotech companies over a period of years. Our team includes functional experts in ‘discovery to distribution’ supply chain best practices across the Life Sciences spectrum, to include manufacturing, quality and supply chain integration for both small molecule and biopharm production. Our team are versed in global regulations and compliance requirements (EU, MHRA, EMA, FDA, ANVISA, USP, WHO, ISPE) for best in class storage and distribution – end to end supply chain.
Problems we have solved in collaboration with client team members include:
Supply Chain Assurance for Disposable Reactor Components
Biotech division of Big Pharma company was expanding operations that were increasingly dependant on disposable components for their bioreactors. Current supply based was fragmented and service levels were inconsistent. Team reviewed demand and supply data and developed a supplier rationalization strategy. All suppliers were evaluated under key criteria related to Quality, On time and In Full (OTIF) as well as total cost of ownership. Supply Agreements were put in place with related contracts and service level agreements
Compliance with Good Distribution Practices cGDP
Global Contract Manufacturing Organization was outsourcing all logistics operations. Needed clearly defined processes and procedures to ensure consistency and compliance across internal and external distribution operations.Cross functional team appointed to review process level requirements across European manufacturing and distribution operations. Developed compliance framework to include audit standards and standard operating procedures.
Technology Transfer to Contract Manufacturing Partner
Global Big Pharma were rationalizing their Latin American operations and wished to transfer existing portfolio of products to CMO in Brazil – Project team of local technical resources, with USA oversight, provided the expertise required in order to develop transition plan. Focus included inbound materials to manufacturing, production planning, scheduling, manufacturing, labelling and distribution. Close liaison with CMO operations team to ensure supply chain elements included in transition plan
Feasibility of RFID for surgical instrument tracking
US manufacture of surgical instruments was evaluating the viability of using RFID to track location of items used in surgical suite. Challenges included read range as well as sterilization of instruments at extremely high temperatures. Team reviewed process flow and activities in surgical suite. Developed implementation conceptual overview and evaluated impact of environmental hazards on RFID performance. Developed for evaluation of RFID partners and implementation
Supply Chain Strategy for Commercialization of Biotech Product
Product development, clinical trials for oncology treatment completed and team were challenged by transition to commercial distribution model. High value product with short shelf life and complex packaging requirements for time and temperature control. In partnership with client team, New Creed SME developed process models for risk assessment and development of functional specifications for packaging, storage and distribution. Developed RFP for third party logistics partner selection with associated SLA to ensure cGDP compliance.