Efficient Integration of Single-Use Equipment During Capacity Expansion Projects

By Nick Hutchinson

More than ever before, biopharmaceutical companies are able to establish their own in-house biomanufacturing capabilities. The adoption of single-use technology has reduced the need for expensive utilities systems and large manufacturing footprints. The inherent flexibility of this technology is allowing firms to connect steps in the production process with relative ease and without the need for fixed stainless steel pipework. Upfront capital costs have diminished and although operating costs remain, they are incurred only when the success of a drug candidate or licensed product warrants further production. Thus, single-use technologies provide a means to mitigate the risk of wasting large capital expenditures in the event a molecule is unsuccessful in the clinic or on the market.

Good engineering practices are key

Single-use technology is available for nearly every step in a biopharmaceutical manufacturing process below a certain scale of production. Biologics such as monoclonal antibodies and viral vaccines can be produced using processes in which the entire product, media and buffer flow-paths are disposable. However, companies attempting to install or expand new biomanufacturing capacity should be mindful that they should follow good engineering practices to maximize the probability of success. Despite the ease with which firms can install single-use capacity, relative to traditional stainless steel projects, this can nevertheless lead to an insufficient consideration of how firms should integrate single-use equipment with other steps in the process chain. The overlooking of proper integration can lead to incorrect equipment sizing, poor equipment design or an incomplete solution being developed. This can result in process failures, delays and the need to perform costly engineering rework.

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Monoclonal Antibody Platform Processes

By Nick Hutchinson

Therapeutic monoclonal antibodies (mAbs) have had a significant impact on both medicine and the biopharmaceutical industry. Oftentimes different mAb products will have similar properties to one another. In turn, this means companies can use similar production methods to produce multiple mAb treatments from their product portfolio or pipeline. I spoke to Dr Piranavan Thillaivinayagalingam, Director of Project Management from Alvotech Germany to learn more about the industry’s current approach to manufacturing mAbs with platform processes.

What does the phrase ‘platform process’ mean to you?

Platform processing, to me, means having a standardized approach to a range of activities required to develop and operate a biologics manufacturing process. These activities range from cell line development through to steps for the formulation of drug substance. Standardized activities allow drug developers to perform these steps in the fastest and most cost-effective way. In my role, platform processes are particularly important in getting products through to clinical phase I and II manufacturing as quickly as possible.

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The Early Stage Development of Biopharmaceuticals

By: Dr. Nick Hutchinson

Biopharmaceutical companies are placing great focus on the way they perform process development activities at the earliest stages of the product lifecycle. It is a field in which considerable research and innovation is taking place as firms attempt to make best use of their resources and gain competitive advantage. To find out more about the way in which companies are adapting their early stage development approach I spoke to Dr Will Lewis, Head of Purification Research, Biopharm Process Research at GSK.

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What are the current challenges in Bioprocessing?

Here at the Bioprocessing International European Summit, we asked a number of leading industry experts from across all sectors of the industry what are the biggest challenges they are currently facing in their work, and what is being done to resolve and overcome these challenges.

Parrish Galliher, Chief Technology Officer for Upstream, GE Healthcare outlines his thoughts on current challenges.

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Partnerships Between Big Pharma and Small Biotech Companies – What are the Benefits?

The sharp rise in partnerships between big pharma and small biotech companies has highlighted a scramble for assets in the cell and gene therapy industries. As excitement around the sector grows and competition intensifies, James Miskin of Oxford BioMedica believes the ability to make partnerships is critical:

“My belief is that a strong, two-way, reinforcing, supporting partnership is a very good business model. It allows the bigger company to learn and it allows the smaller company to continue to invest, and to expand in what they already do well.”

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Bringing Orphan Drugs and Gene Therapies to Market: Maximising ROI through an Effective Communications Plan

Businessman with business plan concept analysis strategy questions

Howard Sinclair, Strategic Director – Rare Diseases and Gene Therapy, The Prime Medical Group, UK, and Andrew Jobson, PhD, Senior Editorial Manager – Rare Diseases and Gene Therapy, The Prime Medical Group, UK, are talking at Cell Therapy Manufacturing & Gene Therapy Congress on Wednesday 3rd February in Brussels. Here they explain what they’ll be talking on:

“There are a multitude of urgent and critical areas to address in further developing your orphan drug or gene therapy to achieve the next milestone. They consume all your team’s energy, resources and time, and there never seem to be enough hours in the day. Against this reality, is creating a communications plan really that important? – Yes! Won’t the external communications just happen naturally anyway, as the relevant data become available? From decades of experience supporting everything from mega-blockbuster first-in-class agents, to very specialised medicines for the most obscure ultra-rare diseases, we would respectfully and emphatically answer: No.

Unique challenges exist for rare diseases, orphan drugs and gene therapies that require tailored solutions, distinct from standard approaches. Creating a robust, evidence-based, authentic and compelling scientific narrative is the starting point – and you will need a sound plan to effectively share this with potential product users, key influencers and the broader healthcare community. This could include clinical trial investigators, practicing specialty clinicians, primary care providers, nurses and payers.

An effective strategic communications plan is critically important, enabling you to optimally engage with your target audiences at the right time (which will likely vary over the course of the development of your asset) to achieve your immediate and long-term goals, whether it’s accelerating clinical trial accrual or ensuring optimal awareness and adoption into clinical practice upon market authorisation. Early development and initiation of a tailored, proactive and cohesive communications plan is arguably even more critical for orphan drugs and gene therapies to ensure your limited resources are most effectively channelled.

Topics to be covered will include:

  • Adding value to your product/clinical studies programme with a tailored medical communications plan.
  • Addressing the specific challenges for a medical communications plan in orphan drugs, rare diseases and gene therapy.
  • Driving the communications strategy through a focus on the unmet needs of both the patient and the healthcare professionals.
  • Defining the key elements of an optimal communications plan.
  • Making the plan happen – driving the initiation, management and delivery.

Creating a robust and tailored strategic communications plan is critical to success – we will explore the why, what and how.”

See the full agenda for Cell Therapy Manufacturing & Gene Therapy Congress and buy tickets at https://celltherapy.knnlab.com.