Newsletter archive
BioPhorum newsletter | September 2023
September's featured articles
- The filling line of the future – industry needs for aseptic manufacture.
- Best practices for demonstrating comparability for clinical cell-based therapies.
- On your marks, get set, go! How to start your data governance project
- Process analytical technology for CGTs – the big discussion
- Where to start with your biomanufacturing digital transformation
- The non-equivalency of the CFU with the AFU – the challenges.
- Addressing industry issues: the value of collaborative learning through BioPhorum
- BioPhorum Council – An update on the key outputs from the council and the program ahead
BioPhorum newsletter | August 2023
August's featured articles
- Why proposed EtO sterilization changes present a serious risk to patients
- Identifying Critical Quality Attributes for mRNA/LNP
- Facing challenges on CGT method validation controls? Read our guide
- Bringing drugs to market earlier with greater patient centricity
- A structured approach for the evaluation, validation, and implementation of NAT-based mycoplasma detection methods
- Standardizing traceability of personalized cell and gene therapies
BioPhorum newsletter | July 2023
July's featured articles
- BioPhorum’s patient-centric framework for developing the inbound supply chain
- Moving the industry toward a sustainable inbound supply chain of the future
- Lessons learned during the pandemic and how BioPhorum’s Risk and Business Continuity Workstream helped: Merck’s approach to risk management
- Water droplet acceptance criteria – the BioPhorum guide
- How to accelerate the commercialization of your mRNA therapies
- The key questions you should be asking when deploying AR/VR
- Guidance on minimizing the impact of stability studies on gene therapy batch yield
- The global picture of AI in the biomanufacturing industry
- Vision for digital integration of sponsor and contract organizations
- The key topics discussed by senior leaders at the Annual BioPhorum
BioPhorum newsletter | June 2023
June's featured articles
BioPhorum newsletter | June 2023
June's featured articles
- An industry first – unifying the release standards for CGT endonuclease ancillary materials
- Building solid foundations for aseptic process simulation
- ‘Materials of concern’ and the rapidly changing environmental and sustainability regulatory environment
- Learning to operate at your best: The story of how BioPhorum membership provides valuable insight into market-wide conditions
- What is Senior BioPhorum Connect
- Rapid sterility test systems in the pharmaceutical industry: Applying a structured approach to their evaluation, validation and global implementation
BioPhorum newsletter | May 2023
May's featured articles
- BioPhorum’s vision for standardizing the traceability of CGTs
- How to minimize the impact of CCIT on gene therapy batch yields
- Takeda details how a BioPhorum paper was cited in response to an FDA request
- The M3 Collaboration – bringing together experts in Modern Micro Methods
- Need a common language on lead times? Here it is
- Connect the value of BioPhorum to your corporate strategy
- Lessons learned during the pandemic and how BioPhorum’s Risk and Business Continuity Workstream helped: NewAge Industries approach to risk management
- MediPhorum presents: Highlighting key MedTech industry challenges – Advanced wound care and wound management
BioPhorum newsletter | April 2023
April's featured articles
- Regulatory CMC
- Introducing the new MediPhorum
- How to make business continuity management a critical pillar of your supply chain success
- Registering innovative raw materials using QbD principles: Protein A resins
- Speed to First-In-Human: streamlining development activities
- Recombinant Factor C endotoxin testing – all your questions answered
- Digital technology roadmap – the story so far
- Robotics and automation providers: realize greater connectivity through our new membershipÂ
- BioPhorum’s input on ICH guidance on products derived from cell lines of human or animal origin
BioPhorum newsletter | March 2023
March's featured articles
- BioPhorum Technology Strategy – accelerating your technology transformation and adoption
- A nine-step approach for NAT-based mycoplasma detection
- The Annual BioPhorum – Welcoming champions of the biomanufacturing industry
- How successfully implementing alternative sterility tests can achieve a ~50% reduced incubation time
- Achieve a best-in-class supply chain through long-range planning
BioPhorum newsletter | February 2023
February's featured articles
BioPhorum newsletter | January 2023
January's featured articles
- How are you improving your environmental sustainability performance?
- Drive your project faster with the URS of the future
- Supply Chain to Patient has launched!
- Accelerating industry progress with the new BioPhorum Council
- How to predict, optimize and analyze high-concentration biologic therapeutic formulations
- The survey results are in – worst-case conditions for viral clearance
BioPhorum newsletter | December 2022
December's featured articles
- How to bridge the data integration gap between sponsors and contract organizations
- A media fingerprinting toolbox that comes with a host of benefits
- Do you want to influence the future of long-range planning?
- Plasmids release specifications: aligning industry in a bid to reduce costs, timelines, and testing
- Challenges encountered in the implementation of bio-fluorescent particle counting systems as a routine microbial monitoring tool
BioPhorum newsletter | November 2022
November's featured articles
- Electronic data exchange – the foundation for an efficient, resilient inbound supply chain
- The benefits of a joint audit approach at Pall Corporation
- Everything you need to know about ‘ready to use’ cells … on a poster
- How the bioprocess industry has weathered the COVID-19 storm
- BioPhorum’s Deliverables Report 2022 – all our content at your fingertips
- BioPhorum introduces – Needs and considerations of CGT supply chains
BioPhorum newsletter | October 2022
October's featured articles
- Now you can have a simple, compliant, and valuable equipment revalidation strategy
- Control of empty, full and partially filled capsids – BioPhorum establishing an industry position on this critical quality attribute.
- Helping the ICH refine its guidance on analytical proceduresÂ
- How to avoid the ‘valley of death’ when adopting new technology
- Using DPMM to build the future digital journey
- BioPhorum Connect in conversation with Bristol Myers Squibb on collaboration across the supply chain
- Virtual twins for biomanufacturing
BioPhorum newsletter | September 2022
September's featured articles
- BioPhorum’s strategic framework shines a light on raw material management
- Quality, safety, and cost benefits with BioPhorum’s supply change notification template
- BioPhorum Introduces – Sustainability in conversation with Ipsen
- Are you on the right road to unlock the value of digital technologies?
- BioPhorum membership
- CGT environmental health and safety
- Enabling adoption – collaboration delivers fully tested proof of concept design and dataset for NIIMBL-BioPhorum Buffer Stock Blending System
- A best practice approach for lyophilizer leak rate testing
- Adopting BFPC systems: how BioPhorum is increasing the pace of change
- How agile and sustainable is your supply chain? What is your approach to data transparency? How can you improve the efficiency and cost of the supply chain?
BioPhorum newsletter | August 2022
August's featured articles
- BioPhorum Medtech human factors survey – what do you think?Â
- Building on industry feedback to standardize plasmid release specifications
- Improving the understanding and clarity around ‘on-time in-full’
- Why BioPhorum’s modern microbial methods evaluation roadmap is a foundation for successÂ
- Quality and regulatory alignment of the BioPhorum technical workstreams
BioPhorum newsletter | July 2022
July's featured articles
- How fully implemented ILM/RTR will be a quantum leap for industry
- A nine-step framework for evaluating alternative adventitious agent testingÂ
- Using modular construction to reduce time to market and lower costsÂ
- Improving supply chain quality management through a common language
- How using BioPhorum’s change notification best practices have helped create a clearer and more efficient dialogue with customers
- BioPhorum survey shows the scale of industry’s indirect carbon emissions challenge
- BioPhorum introduces – Sustainability In conversation with AmgenÂ
- What’s changing in the Chinese CMC regulatory environment?Â
BioPhorum newsletter | June 2022
June's featured articles
- Why BioPhorum’s trace element approach will save you time, money and wasted batches
- Here’s how BioPhorum’s ‘one voice’ is helping industry save $millions in Colombia
- New value-add tools to complement BioPhorum’s forecast and demand planning toolkit
- Helping you to identify the risks in your line clearance process and do something about them
- Tackling the five crucial data integrity challenges in QC labs
- BioPhorum introduces – Sustainability in conversation with Cytiva
- Leveraging the CGT process maps
- Meet the new Supply Partnering & Relationship Management Workstream – do you want to get on board?
BioPhorum newsletter | May 2022
May's featured articles
- Is it possible to do real-time analysis of aggregates in downstream protein solutions?
- What do your key players need from IT systems in your CGT processes?
- From paper to practise – a case study in PUPSIT
- Making your extractables data accessible is easy through BioPhorum’s portal
- BioPhorum is delighted to announce the appointment of Tim Hawkins as Chief Executive Officer.
BioPhorum newsletter | April 2022
April's featured articles
- How to understand and mitigate the problem of trace element variation
- How do you want your QC lab rocket to fly?
- Orchestrating the supply of different cell and gene therapies
- Driving collaboration to unleash the power of AR/VR in the biopharmaceutical manufacturing environmentÂ
- BioPhorum introduces – Sustainability
In conversation with Corning - New technology adoption moves into the fast lane
- Reducing human error through automated colony counting systems
BioPhorum newsletter | March 2022
March's featured articles
- Taming the documentation beast using the power of human performance
- Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics
- Supplier and raw material improvements using BioPhorum’s maturity assessment toolkit
- Boosting training in single-use technologies through vendor and end-user collaboration
- External collaborations
BioPhorum newsletter | February 2022
February's featured articles
- Driving industry consensus on the EU’s Medical Devices regulation
- Welcome to the MES of the future
- Collaborating with USP on its Bacterial Endotoxin Test Protocol and Bioreactivity Draft Monographs
- The four steps for registering innovative and complex raw materials
- How to maximize business value from process analytical technologies
BioPhorum newsletter | January 2022
January's featured articles
BioPhorum newsletter | December 2021
December's featured articles
- How to replenish working cell banks with a risk-based scientific approach
- Ask BioPhorum – a second brain for BioPhorum members
- BioPhorum’s Deliverables Report 2021 – all of our content at your fingertips
- Showcasing the NIIMBL-BioPhorum Buffer Stock Blending System
- How to make in-use stability and compatibility studies a success
BioPhorum newsletter | November 2021
November's featured articles
- With net zero the ultimate target, how can the industry work together to usher in a sustainable future?
- A simplified way to register complex and innovative raw materials in Europe
- BioPhorum’s expert feedback on the FDA’s ICH Q12 guideline
- Bringing the needs of biopharmaceutical manufacturers and their suppliers closer
- Formulation team sweeps away barriers to sharing
- Harmonizing the industry and improving confidence through risk-based microbial testing
- Private: BioPhorum webinars
- Understanding the industry baseline for electronic data exchange implementation across the inbound supply chain
- Why this SUS audit guide will reduce industry’s audit burden
- Forecasting the future with BioPhorum’s Accuracy Calculator
- How to introduce new materials – one gate at a time
- Reflections on Covid-19 inbound supply chain issues
BioPhorum newsletter | October 2021
October's featured articles
- Steps to eradicate undetected contaminations in anaerobic testing
- Seven practices to ensure your patching program is a success
- MedTech celebrates its first year anniversary with new program additions
- The Spontaneous Infection: Did you leave the back door to your cultivation suite open?
- Speed to Clinic initiative launches: learning from the COVID-19 pandemic
BioPhorum newsletter | September 2021
September's featured articles
- BioPhorum technology roadmap vision 2.0
- How to create a toolbox to assess your high-risk HCPs
- Connecting vision systems with how the patient reads a label
- Meeting the challenges in serialization to win in the battle against counterfeiting
- Celebrating achievements and preparing for the long term Â
- The Russian Pharmacopeia: a reflection on the challenges to achieving greater alignment for biologics
- An industry response to the Danish Medicines Agency’s questions on augmented intelligence and machine learning
- How to appropriately classify your cleanroom at early-stage design
- Using a matrix approach to address challenges for potency assay development for in vivo and ex vivo gene therapies.
- Illuminating the challenges of validating cell and gene therapies
- Assessing EHS risks in CGT: a real-world example
- RNA: new CGT workstream to focus on this industry priority
- Overcoming unique challenges to support rapid development of diverse products
BioPhorum newsletter | July 2021
July's featured articles
- A guide to integrating CPV reporting and APR practices
- BioPhorum deliverables mid-year report 2021
- BioPhorum launch new sustainability phorum
- Release specifications for master cell banks – your chance to make a difference
- Chain reaction: how the biopharmaceutical supply chain survived the pandemic
- Supplier change notifications – bringing color to a grey area
- ‘From grass to glass’: how BioPhorum’s Strategic Framework will influence the whole in-bound supply chain
- Overcoming unique challenges to support rapid development of diverse products
- Plug-and-play validation – how much testing do you really need to do?
- On the plug-and-play audit trail to connect intelligent pieces of equipment
