Trends, challenges and priorities

There are many sobering statistics available on the rate at which natural resources are being consumed, the speed at which global temperatures are rising, and the impact this will have on people’s lives. The global consensus is that limiting global temperature rise is imperative. In line with the Paris Agreement (2016) , many organizations across the biopharmaceutical industry have either set or are setting their own science-based targets for reducing environmental impacts, which demand a clearly-defined path to reduce greenhouse gas (GHG) emissions across the end to end value chain.

According to mygreenlab (,

“The global biotechnology and pharmaceutical industry has a carbon footprint larger than the semiconductor industry, the forestry and paper industry, and equal to nearly half the annual emissions of the United Kingdom.”

BioPhorum Sustainability program 2022 infographic

BioPhorum Sustainability represents a deep partnership across the value chain. Our program is jointly designed, governed and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership has meant 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.

Our members have identified two ambitious goals to deliver our 2050 vision – decarbonization and embedding circularity. This will reduce carbon footprint across the value chain, whilst simultaneously reducing waste and extraction.

Transitioning to a more sustainable biopharmaceutical industry

Developing a sustainability industry roadmap has been our focus for 2022 – an important guidance document and a first for the industry. The roadmap defines the key problems the industry needs to address and the actions/enablers to solve them. It specifically looks at the biopharma industry with a focus on raw materials, manufacturing, distribution and use/end of life. Its timeline is now to a sustainable future state in 2050.

High Impact opportunity

Energy usage and emissions
GSK shared guidance with the industry as early as 2017, noting that ”the primary carbon contributions are from the manufacturing facilities, and thus these facilities should be a primary area of focus for carbon footprint reduction across the biopharmaceutical industry. Carbon contribution from material inputs, packaging, labeling and transportation are minor in comparison. Energy-efficient design and operation of the facilities, especially the facilities’ HVAC systems, plant utilities, and process utilities, should be thoroughly evaluated when attempting to reduce greenhouse emissions associated with biological products.”

Biologics manufacturing processes are water intense. Clean water is scarce in many geographical areas, which poses risks of operational shutdowns, which could in turn affect business continuity and ultimately patient access.   Industry knowledge and expertise is developing in this field but there remains a lack of widely accepted, innovative, or technical solutions, which inhibits the use of reduce/reuse/recycle technologies, especially where regulatory and quality requirements are considered.

Single use systems have made a valuable contribution to the industry through flexibility, quality and speed to market (as demonstrated through Covid19. However, plastic waste and its incineration (which results from the current linear model of production) conflicts with emissions, pollution, and waste targets. Coupled with the fact that the design of the materials is heavily reliant on fossil fuels and high-impact materials, through BioPhorum the industry is committed to the responsible deployment of plastics and is working hard to quantify plastics volumes to provide critical data to demonstrate plastic waste flows, connect with potential recycling solutions, and identify opportunities for circularity and sustainable material design.

These industry priorities and high impact opportunities are the basis for all our work within BioPhorum Sustainability:

  1. By establishing decarbonization goals and priorities, we gain common language for organizations to communicate and engage across the value chain – we’re seeing this within our Scope 3 workstream as we identify the categories with the biggest impact
  2. By demonstrating how circularity applies to biopharma, our members understand the opportunities and how they can actually de-risk activities and ensure security of supply
  3. Standardization is critical for transparency on sustainability targets – for example, we’re starting the process of facilitating data flows on GHG emissions and determining a range of plastics baselines for use and waste to support responsible deployment
  4. Through sharing best practice in-industry and beyond, the Phorum is identifying where collaborative innovation will accelerate lead times through proof of concepts and joint research, which in turn will accelerate adoption
  5. The changes required to move towards net zero and more circular processes will come with regulatory requirements – signposting these to prepare for change is a key part of the Phorum’s work. As is preparing for an unprecedented scale of change to filed processes and technologies. To this end, we’re working closely with the regulatory governance team to make best use of their work on post-approval change management and Quality by Design
  6. Inspiring and igniting engagement from all parts of the talent pool, the roadmap is a call to action for all; from highlighting where direction and commitment is needed from the highest levels, through to best practice on embedding sustainability operationally, from R&D to procurement. To facilitate this, we’re working on industry-wide education on key concepts, further developing that common language for all.

We have a unique opportunity within the BioPhorum family to connect strategy and policy to practical application. We are the only focussed E2E collaboration within the biopharma industry addressing sustainability

We are actively thinking about how to tap into the 7000+ changemakers we have in our network to accelerate the industries sustainability progress across all fronts. How can we accelerate adoption of previous work developed in the name of efficiency, but which also affords the industry significant sustainability benefit – the adoption of closed systems as an example. How can sustainability add further weight to the business case for much needed change around data and digitization – traceability of raw materials as an example. Over time we expect that sustainability initiatives will become embedded within each of our Phorum programs, and that BioPhorum Sustainability will guide progress through education, policy setting and in some areas cross-phorum working.

Sustainability deliverables June 2022 to June 2023

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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. 


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.


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

Plasmids release specifications are critical to the manufacture of many cell and gene therapy (CGT) products, but current regulatory... read more

How to predict, optimize and analyze high-concentration biologic therapeutic formulations

Developing high-dose biologic drugs for subcutaneous injection often requires high-concentration formulations. It also needs to optimize... read more

A media fingerprinting toolbox that comes with a host of benefits

Cell culture media raw materials can contain many chemical substances, each with its own properties. While simple substances can be... read more

Why 100% visual inspection does not mean 100% defect detection

There is a common misunderstanding that 100% visual inspection (VI) of biopharmaceutical products should mean 100% detection of defects.... read more

How to bridge the data integration gap between sponsors and contract organizations

Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics

Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and... read more

Supply Chain to Patient has launched!

Have your outbound supply chain costs increased? Do you want to leverage data and digital technologies more effectively to reduce... read more

Electronic data exchange – the foundation for an efficient, resilient inbound supply chain

The COVID-19 pandemic, geopolitical unrest, and military action across the world have fundamentally disrupted the assumption and practice... read more

How are you improving your environmental sustainability performance?

Climate change and global warming resulting from greenhouse gas emissions are widely recognized as the biggest threats to global health.... read more

Adding value for analytical instrument partners

Analytical instrument vendors have been integral to developing and publishing our technology roadmaps and developing product... read more

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
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