Guidelines for materials introduction supporting drug substance delivery

There are many challenges during drug substance supply in a biopharmaceutical new product introduction (NPI) process. Clinical supply programs are frequently subject to change and therefore supporting drug substance (active pharmaceutical ingredient (API)), supply requirements can be extremely variable. Given this unpredictability, key supply issues can arise, such as:

  • Traditional forecasting and demand processes for managing a biopharmaceutical NPI are often unable to ensure a robust supply performance. Therefore, API customer schedule adherence becomes extremely challenging
  • NPI manufacturing processes are often characterized by their lack of robustness and predictability at this early stage of development
  • Manufacturing operations can also encounter complex and diverse NPI supply chains, which may be partly external to their plants, utilize novel ingredients/platforms or be in-licensed because of an acquisition.

In a worst-case scenario, the inability to deliver from any part of a newly created supply chain could impact the clinical program and launch schedule. There are also significant technical and quality risks that could place the supply of drug substance on the critical path of a clinical program. Ultimately, the patient could be impacted if the supply chain does not deliver to promise.

This area has been a significant focus for BioPhorum Supply Partner (SPP).  To improve NPI business operations, the team recognized that a specific NPI biopharmaceutical supply process, focusing on materials introduction, could be collaboratively developed between API manufacturers and their suppliers.

Members of the Forecast and Demand Planning Workstream have developed a standard process map providing industry with a set of simple tools containing a structured approach for materials introduction across the supply chain. It summarizes a stepwise process that can be used as a guideline for introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company-specific NPI procedures. The guidance is relevant best practice for cell and gene therapy manufacturers too.

Attached Files

File
Guidelines for materials introduction supporting drug substance delivery November 2021.pdf
Preview
Related Articles
  New product introduction  
Download
  • Version
  • Download 221
  • File Size 544.94 KB
  • File Count 1
  • Create Date 2nd November 2021
  • DOI https://doi.org/10.46220/2021DS006
  • Last Updated

Phorums

Cell & Gene Therapy
>
Development Group
>
Drug Substance
>
Fill Finish
>
Information Technology
>
Regulatory-CMC
>
Supply Chain to Patient
>
Supply Partner
>
Sustainability
>
Technology Strategy
>

Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges. To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory-CMC

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

Building on industry feedback to standardize plasmid release specifications
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

How to predict, optimize and analyze high-concentration biologic therapeutic formulations
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

A media fingerprinting toolbox that comes with a host of benefits
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

Why 100% visual inspection does not mean 100% defect detection
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

How to bridge the data integration gap between sponsors and contract organizations
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

Supply Chain to Patient has launched!
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

Electronic data exchange – the foundation for an efficient, resilient inbound supply chain
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

How are you improving your environmental sustainability performance?
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

Adding value for analytical instrument partners
Guidelines for materials introduction supporting drug substance delivery There are many challenges during drug substance supply in a... read more

MediPhorum

Introducing MediPhorum
>
Advanced Wound Care and Wound Management
>
Drug Delivery
>

Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum
MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Deliverables

Deliverables Report
>
Industry Priorities
>
Downloads
>
Case Studies
>
Webinars and Podcasts
>
BioPhorum Deliverables Report
BioPhorum brings you the latest Deliverables Report, an informative and inspiring consolidation of the benchmarks, position papers, guidance documents, assessment tools, industry user requirements, study results, and roadmaps produced in the last twelve months.
Technology Strategy
Buffer stock blending system
Knowledge management
Technology adoption
Operations
Change notification
Closure playbook
Extractables and leachables
In-Line Monitoring and Real-Time Release
Raw materials
Regulatory Governance and External Partners
Single-use systems
Annex 1
Information Technology
Digital integration of sponsor and contract organizations
Digital plant maturity model
IT for cell and gene therapies
Lab of the future
BioPhorum Downloads
Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.
Case Studies
Welcome to the BioPhorum case studies page, where you can learn how our clients have used our service to discover innovative solutions and save money. Here you can read real-life stories of how various organizations have used our unique data-driven approach to streamline their processes and make the most of their resources. Whether you're looking for inspiration or want to learn more about the potential benefits of our service, you'll find it here.
Webinars and podcasts
Welcome to BioPhorum Connect, the podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, this podcast brings you the insights and perspectives of experts from around the world. We'll discuss all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. So, join us on our journey as we explore the world of biopharmaceuticals and learn from the perspectives of those at the forefront of the industry.