Case study

Learning to operate at your best: The story of how BioPhorum membership provides valuable insight into market-wide conditions

Venair is an emerging company in the biopharmaceutical industry, engineering and manufacturing silicone hoses. It identified BioPhorum’s Single-Use User Requirement Toolkit as an essential aid to support its work with customers, adapting and implementing it across its company. Ultimately this created so much value for the business that Venair sought BioPhorum membership.

We spoke with Nasim Adnan Moucharrafie, Director of the Biotech Division at Venair Group, about its BioPhorum membership and the benefits of being part of the Supply Partner Phorum.

Venair logo

What led you to join BioPhorum?

We knew about the various BioPhorum activities, such as the industry-wide best practice setting work in the extractables area. But our size and level of activity in the industry meant that it never seemed a good time for us to join. As the covid pandemic struck, there was a need to support the additional demand volume created by vaccine production. This provided growth opportunities for Venair and, with our increasing traction in the industry, it made perfect sense for us to join BioPhorum. This was all a milestone for us and opened a new chapter for our company. Our membership is part of a wider campaign that includes a new corporate branding with increased digital presence, new production facilities in Spain and the US, better-organized product development and a more technical sales force. We’re now in our second year as BioPhorum members.

How have you benefited from the Supply Partner Phorum?

We’ve incorporated many BioPhorum tools into our products, such as the Extractables Protocol. We adapted the Single-Use User Requirement Template to our needs and have used the Supply Change Notification Protocol.

We’re a small company, so successfully investing in new facilities, offices, locations, or product lines (with the regulatory load and expense these involve) is not something that can be easily forecast. However, being in the Phorum shows that everyone has the same issues, and we gain valuable insights into market-wide conditions.

And while nobody shares their strategy, we can see patterns and identify actions to take to be much more effective and achieve our goals. Knowing the industry consensus on an issue is really helpful and can be the simplest thing or the most complicated. For example, I remember the Phorum’s Baltimore meeting where we talked about having an understanding between suppliers and users about the minimum time between a purchase order and delivery. Such knowledge is invaluable to us.

How would you define your involvement and expectations in the future?

We are new to being a biopharmaceutical supplier, which means that we are learning about the type of conversations involved, the length of the projects, the complexity we can expect from them, how demanding quality departments are, etc. We don’t see these things in our industrial or even in our food-pharma clients, where the items we supply are considered non-critical components. So, the unique insight that being a member of BioPhorum gives us is a perspective that helps us to be better prepared for our customers.

This sector is highly regulated, and things need to be done in a very specific way. We need to be like other biopharmaceutical suppliers. To do that, there is nothing better than asking biopharmaceutical end-users directly

BioPhorum is the perfect platform for that.

Nasim Adnan Moucharrafie, Director of the Biotech Division at Venair Group

What’s the main benefit of your experience with BioPhorum?

A lot of business happens when you have trust in people, and they trust you. Earning this requires more than, for example, discussing a presentation. You need to spend hours with your peers and customers, work with them, see how they are when they are happy and when they socialize. Only then will you start to grasp whether someone is the type of person you want to do business with and vice versa. Yes, companies work together, but it’s the people and their relationships at a personal level that makes a business a success or not. BioPhorum and its face-to-face meetings are where you get to know people and build that trust and those relationships. It’s where you learn how to operate at your best.

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.

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

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Supply Chain to Patient has launched!

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

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How are you improving your environmental sustainability performance?

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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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