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Closed, automated cell therapy manufacturing – is your facility ready?

The cell culture process is a crucial step when producing cell therapies and needs to be carefully conducted to avoid contamination. Yet manual, open handling is still common. Could closing and automating the process be the right choice?

The future of fill-finish facilities in pharma manufacturing

What's next for fill-finish pharma manufacturing? With personalized medicine, highly potent drugs and small batches the new norm, we are looking at a digital, sustainable future with far more automated isolators and closed processes.

Virtual or on-site pharma audits? How to tackle the backlog

After over a year in a pandemic, what happens next with pharma audits? Should companies wait until audits can be done on-site once again, or should they consider doing things remotely for the foreseeable future?

How was the PDA Annual Meeting? Vaccines, aseptic processing and GMP updates

Unsurprisingly, the spotlight was on Covid-19 at the 2021 PDA Annual meeting. How has the impact of the pandemic affected the pharma industry and the authorities? And what other topics took the stage?

Digital transformation: Aligning strategy, business model and organization

To stay competitive, the pharma industry needs clear goals and a strategy to start digital transformation. Read more in this step-by-step guide.

Make informed decisions - estimate unit cost before investment

A vital part of cost-effective pharma productions is balancing investment and unit cost. Find out how unit costs (or operating expenses) are calculated, and what the best route could be for your company.

Sustainable pharma: Strike the balance between investment and value

Sustainable investments are growing in the pharmaceutical manufacturing industry. So how do companies move further to meet their increasingly ambitious sustainability goals while balancing costs?

Need to build a data strategy to meet your pharma business goals? Here’s how.

A four step plan to utilise the vast amounts of data generated by pharma manufacturing production facilities.

How to use data and improve OEE in pharma manufacturing

In pharma manufacturing, optimized production facilities fully controlled by Artificial Intelligence (AI) are the goal. But value creation in this area is not always clear, especially short-term.

Cracking the automation code for gene therapy manufacturing

In this TechTalk article, we will explore the key challenges - and potential solutions - for automation of gene therapy manufacturing.

Key challenges for cell and gene facilities

Cell and gene therapies have a huge amount of potential - but also a lot of challenges. Find out how to tackle the issues.

Digital transformation of laboratory operations

Want to launch products faster and cut down costs for the development/production of products? You should consider digital transformation of your lab operations.

Flexible, modular solutions for laboratories

Labs are often planned or established before it is clear which processes and technologies they actually need. The answer to this problem? Adaptability.

Cell and gene therapy: From research to early clinical manufacturing

Novo Nordisk's facility for cell-based and allogenic therapies had some unique challenges and solutions. Find out how we navigated the cell and gene therapy journey from R&D to clinical manufacturing.

Are single-use systems for pharma production a sustainable choice?

Are single-use systems, compared to traditional stainless steel, really sustainable?
The quick answer to this question is, in general, yes they are. Find out why!

Think big, start small and scale fast to kick-start manufacturing intelligence

The key to succeeding with manufacturing intelligence is to think big, start small, and scale fast - but what does that really mean? Find out here!

Make better energy choices with building simulation

How can the pharma industry use building simulation to test energy optimization ideas? Find out how it works and why it makes sense in this TechTalk article.

A four-step roadmap to ensure sustainability progress in pharma facilities

How do you make sure that your facility meets sustainability goals? Learn how to go from vision to reality using a simple four-step model.

How circular economy thinking can benefit the pharma industry

Pharma can embrace circular economy thinking – but it requires new ways of working together towards common sustainability goals. See two example of this symbiosis from Kalundborg and Hillerød in Denmark.

How to practically apply artificial intelligence and machine learning to accelerate Pharma 4.0

AI and ML are the most important drivers for Pharma 4.0. But how do do you apply these new technologies in practice to obtain real results?

How extended reality boosts daily operations in pharma manufacturing

Find out how extended reality (XR) technologies can boost daily operations in your pharma facility.

Virtual solutions in pharma – the regulatory aspect

Find out what key considerations you need to make when bringing virtual solutions into your pharma processes.

Three simple ways to improve energy efficiency in pharma manufacturing

Learn how pharma manufacturers can quickly improve energy efficiency without compromising safety.

Creating value from big data in pharma manufacturing

If data is used correctly in pharma manufacturing, big data can be very useful. However, many pitfalls exist along the path towards these results. Find out what they are here.

How to benefit from digital twins in pharma manufacturing

What is a digital twin and what can it be used for? Find out how this technology is used in the pharmaceutical manufacturing industry.

Cut costs with strong automation design for distribution systems

Underestimating the value of a careful automation design for distribution systems can be very expensive long term. Read about some of the potential problems - and tips for making a strong automation design.

Achieve operational excellence by turning challenges into opportunities

The "secret" to achieving operational readiness and operational excellence includes focusing on your early project phases and turning challenges into opportunities.

Databased road map to continuous control strategy and real-time release

Read how advanced statistical analytics methods can lead to 30% increase in average yield and 70% reduction in yield variation from batch to batch.

Executing fill and finish projects with conflicting market requirements

The manufacturing and regulatory challenges that come with the rise of aseptic technology will inevitably impact project execution.

Changing scenarios, changing technologies: Biotech must get agile

Pipelines are increasingly diverse and volume demands uncertain. How can biotech players stay afloat in this changeable manufacturing landscape?

Is continuous manufacturing the best solution for your biotech facility?

The benefits of continuous manufacturing are clear, but does that mean that it is the right solution in any facility? Find out about the pitfalls and whether it is right for you.

How can new GMP regulations inspire and improve biosafety?

The core focus of GMP is protecting the product and the patient. The core focus of biosafety, on the other hand, is protecting the operator and the environment. The challenges are different, but could the solutions be the same?

Continuous processing - present and future challenges

What's the key to successful implementation and operation of continuous processing? People.

How can data integrity bring you closer to digital transformation?

While other manufacturing industries discuss Industry 4.0 and Big Data, pharma manufacturers are securing the integrity of their regulatory records.

CAR-T cell therapies trigger a pharma manufacturing revolution

Unique, personalized drugs like CAR T cells require a change in pharma manufacturing mindset.

The future of pharma where robots and workers co-exist

Where are the robots? Pharma 4.0 brings robots - and they bring new challenges and opportunities.

Are you ready? Making a robotics strategy

The fourth industrial revolution is upon us and emerging technologies like robotics are dominating the manufacturing industry. Is your pharma facility ready for robotic solutions and pharma 4.0?

Increasing flexibility with control strategy

The key to manufacturing a consistent, quality product is the control strategy. Understanding the process and mitigating risk is crucial.

Robotic solutions are changing the game of biotech

With the FDA encouraging the use of innovative technologies, it’s only a matter of time before the use of robotics in biotech goes from first-mover to standard.

Continuous manufacturing – how do regulators differ in their approach?

In the highly regulated pharmaceutical industry, what do global regulatory authorities think of emerging technologies like continuous manufacturing?

Trained staff: single-use implementation’s missing link

Implementing single-use technology in biomanufacturing sparks an overlooked question – what good is a single-use system with no one to run it?

Personalized drugs transform the way authorities handle GMP

With an increase of personalized medicine, regulatory authorities must approve products faster. What else have personalized drugs changed in GMP?

Risk drivers when designing a flexible manufacturing facility

Achieve true pharma manufacturing flexibility, support your business driver and satisfy regulatory authorities with focus on three key risk drivers.

Optimizing continuous manufacturing with robotics

Robotics can help pharma companies reach the goal of continuous manufacturing. But what else have robotics got to offer the pharmaceutical industry?

Single-use technology left its mark but where is it heading?

Single-use technology is pushing new boundaries, making strides in fill finish, continuous processes and even honing in on the 2,000 litre bioreactor.

Pharma manufacturing control strategy starts with the patient

A robust control strategy is a good manufacturing practice ‘must.’ So how do you get started on establishing this interdisciplinary game plan?

Get closure (and analysis) in pharma manufacturing systems

The FDA is in your facility, asking about microbial control of your closed process system. What do you do?

Robots are coming and they’re automating pharma research

What can pharma manufacturing gain from implementing robotics and automation in the earliest part of the pharma value chain – research and development?

Are PODs the future of flexible pharma manufacturing systems?

The pharmaceutical industry is slow to adopt advanced manufacturing systems but one company broke away from this reluctance and took a chance on PODs.

Get to know pharma-focused Quality by Design (QbD)

QbD principles are still not the standard for all manufacturers’ pharmaceutical facility design. So why should the pharma industry take QbD more seriously?

Quality by Design - from patient to control strategy

Neglecting to develop a robust control strategy not only affects your business, but also holds severe consequences for the patient.

How single use systems could revolutionize fill finish changeover

Single-use systems can speed up changeover of fill finish production lines without compromising sterility. Could this be the “shortcut” to success?

The million-dollar question: stainless steel or single-use?

Sometimes, the right solution is a combination of technologies, which offers the most productive and cost-effective process in a fast and predictable way.

Realizing the cost advantages of single-use technology

Pharma manufacturing embraces single-use technology, as it can simplify facility design and save cost. So how can engineers measure and capitalize on this?

Risk and reward with single-use systems in high containment

Implementing single-use technology in pharma manufacturing is possible with high containment drugs, but it means satisfying conflicting agendas.

Flexibility – the future of pharma manufacturing

From single-use systems to continuous manufacturing – which tools do you use to tackle the new pharma reality where agility and flexibility reign supreme?

Biotech facility concepts to tackle personalized medicine

When redoing the batch is not an option, how are pharma manufacturers preparing for the increased personalized medicine and cell-based therapies?

High containment becomes high priority in pharma

Implementing containment within pharmaceutical manufacturing, is a matter of how, not when. Which level of closure is necessary for your drug production?

What the personalized medicine boom is doing to facility design

Autologous cell-based therapies are moving are taking the world of pharma manufacturing by storm. What can manufacturers expect from personalized medicine?

What closed systems mean for bioprocessing facility design

Closed systems can prevent the contamination of products, workers and a facility. It’s no wonder that this technology is becoming a foundation for biotech system design.

3 key approaches to pharma manufacturing control strategy

With many considerations like the patient, GMP compliance and production, where do you begin when outlining a control strategy for pharma manufacturing?

The value of a control strategy for legacy products

With this method, you can potentially convert 100 possible CPPs to a prioritized list of less than 10 CPPs.

Aseptic technology on the rise

Injectable drug production isn’t slowing down – and as a result, neither is aseptic technology. Find out what regulatory authorities think of aseptic production.

Step-by-step risk analysis for continuous manufacturing

With complex drug development and pharma manufacturing, you can’t skip the details. Risk Analysis and Mitigation Matrix (RAMM) is the ultimate catch-all.

Pairing continuous processing and single-use systems

Single-use systems offer unprecedented flexibility for pharma manufacturing. Why not take efficiency to the next level and add continuous bioprocessing?

A breakthrough for pharma manufacturing that is FDA approved

Why is continuous manufacturing so much more efficient compared with batch procedure, and what do the authorities have to say about it?

Pharma manufacturing process waves farewell to batches

The FDA appreciates continuous processes and they can save time and money during pharma manufacturing. So why is the industry hesitant to adopt this method?

Bend it like bio: flexibility in pharma manufacturing

A new generation of biopharmaceutical manufacturing is upon us and it focuses on flexibility and operability. Pharmaceutical plant design is changing fast.

The challenges of personalized drugs - and some possible solutions

Personalized drugs have shifted pharma companies’ roles from manufacturer to solution provider, calling for new collaboration with clinical care segments.

Keeping up with continuous processes for OSD

When it comes to pharma manufacturing, new products beg for a little innovation. With increased speed to market, continuous processes are here to deliver.

Design drivers for flexible pharma manufacturing assets

Start the complex journey of facility design by finding your vision-driver fast. Is it flexibility, agility, simplicity, innovation or all of the above?

Take assembly and packaging to the next level with robotics

With robotic solutions more affordable than ever, the pharma industry is catching on. Learn how assembly and packaging lines are ready to reap the benefits.

Flexible facility design: to scale-up or scale-out?

How do you ensure your resources match the wide scale of your facility? Learn which key challenges to prioritize from capacity needs to segregation strategy.

Biopharma manufacturing in tune with tech transfer

Don’t reinvent the wheel. Get in tune with technology transfer to apply lessons learned and knowledge from existing to new pharma manufacturing facilities.

Speed up launch of new products in the pharma industry

In an industry plagued by delays, the automation standards S88 and S95 might be the solution to speed up tech transfer and launch products faster.

Statistical process control: is it the right business strategy for you?

Developing robust statistical process control (SPC) can do wonders for your quality control. Ensure its lucrative implementation with a successful pilot.

Maximize efficiency, minimize interference in biomanufacturing

Good process design and segregation strategies can maximize efficiency and minimize interference in multi-product, multi-phase biomanufacturing facilities.

Single-use systems: not your average design management

A flexible and cost-effective solution to stainless steel, single-use systems may revolutionize the pharma world. But what does it take to manage their design?

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