2nd Aseptic BioPharma Processing Summit

November 9-10, 2023
Vienna, Austria
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ABOUT THE EVENT

Staying updated on regulatory requirements is crucial for ensuring compliance and maintaining the highest quality standards in drug manufacturing. The new EU GMP Annex 1 is officially published and will take effect in August 2023. How to deal with new challenges, adopt new methods aligning with stricter standards and embrace new innovative technologies?

Our 2nd edition of the Aseptic BioPharma Processing Summit features comprehensive coverage on the implementation and management of the latest knowledge in aseptic, barrier, containment, and aseptic best practice technologies along with environmental monitoring systems, facility cleaning and disinfectant qualification, cleanroom operations, filtration, sterilization, and aseptic process simulation or media fill. This two-day summit encompasses expert insight into the robust aseptic processing requirements facing the industry as well as delving into more focus on the ever-growing rise of advanced therapies from allogenic cell therapies to innovative fill-finish lines.

Come and join us in Vienna this November 9-10 together with manufacturers, regulators, and experts for the industry’s collective knowledge, gain different perspectives, and foster innovation in aseptic pharmaceutical manufacturing.

CONFERENCE LEARNING POINTS

 

  • Overview of new EU GMP Guidelines and Annex 1
  • Cleanroom design and environmental monitoring
  • Optimization of fill finish operations
  • Novel technologies for rapid sterilization and
    decontamination
  • Automation and robotics in pharmaceutical production
  • Single-use systems in aseptic manufacturing
  • New developments in lyophilization and automatic
    vial loading/unloading
  • Developing a holistic aseptic training program

SPEAKERS

Alberto Gonzalez Garrido

Takeda

Takeda has been putting patients first for more than two centuries. We are a global, science-driven biopharmaceutical leader with headquarters in Japan and the U.S., guided by our Patient-Trust-Reputation-Business philosophy. This perspective represents who we are and guides how we act, helping us make decisions we can be proud of today and in the future.

As a member of our team, you’ll help deliver on our mission to strive for better health and a brighter future for people worldwide through leading innovation in medicine. It’s a responsibility that motivates and inspires us all.

You’ll find your own professional inspiration at Takeda, in the area that suits your interests and skills. Whether that’s R&D, Oncology, Corporate, Manufacturing, Quality, or another business unit, wherever you find yourself at Takeda, you’ll enjoy a meaningful career that’s making a positive impact on patients, people and the planet.

Tamara Garcia-Armisen

GSK

GSK plc (GSK) is a healthcare company that focuses on developing, manufacturing and commercializing general medicines, specialty medicines and vaccines. It offers drugs for the treatment of diseases such as HIV, respiratory, cancer, immuno-inflammation, anti-viral, central nervous system (CNS), metabolic, cardiovascular, and urogenital, anti-bacterials, dermatology and rare diseases. The company also offers over-the-counter (OTC) products for pain relief, oral health, nutrition, skin health and gastro-intestinal diseases. GSK’s vaccine portfolio covers various diseases including hepatitis, diphtheria, tetanus, whooping cough, rotavirus and HPV infections, measles and bacterial meningitis, among others. The company sells its products through wholesalers, pharmacies, hospitals, physicians and other groups worldwide. GSK is headquartered in Brentford, Middlesex, the UK.

Andreas Traube

Fraunhofer IPA

With over 1200 employees, the Fraunhofer Institute for Manufacturing Engineering and Automation IPA (Fraunhofer IPA) is one of the largest institutes in the Fraunhofer-Gesellschaft. The total budget amounts to € 90 million. The institute’s research focus is on organizational and technological aspects of production. We develop, test and implement not only components, devices and methods, but also entire machines and manufacturing plants. Our 19 departments are coordinated via six business units, which together conduct interdisciplinary work with the following industries: automotive, machinery and equipment industry, electronics and microsystems, energy, medical engineering and biotechnology as well as process industry. The research activities of Fraunhofer IPA aim at the economic production of sustainable and personalized products.

Klaus Ullherr

Syntegon Technology GmbH

Processing and packaging for a better life – this is what 5,800 Syntegon employees work for every day. Be it with individual machines, systems, or services, we help you – our customers in the global pharmaceutical and food industries – to improve people’s lives. For that we look back on more than 160 years of experience. In the pharma sector, our intelligent solutions enable the safe and high-quality production, processing, filling, inspection, and packaging of your liquid and solid pharmaceuticals. In the food industry, our flexible and reliable technologies produce and package confectionery, dry food, frozen food, and dairy products. With 1,100 service experts and a comprehensive service portfolio throughout the entire machine lifecycle from spare parts management to digital line optimization, Syntegon lays the foundation for your smooth production processes. In everything we do, our more than 35 sites in almost 20 countries keep a firm eye on our impact on the environment and society. Syntegon is a leader in the development of sustainable packaging solutions, reduces the energy consumption of its machines and pursues ambitious goals to lower its emissions.

Suzanne Nutter

AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines.

Our Purpose is to push the boundaries of science to deliver life-changing medicines. We believe the best way we can achieve our Purpose is to put science at the centre of everything we do. Science defines who we are. It is why we come to work every day and is part of our DNA. But this is only half of the story. We know that we do not have all the answers. We want to share ideas because we believe it results in better medicines. We want the way we work to be inclusive, open and collaborative. This approach runs through all that we do.

We focus on three main therapy areas – Oncology, Cardiovascular & Metabolic Disease (CVMD) and Respiratory – and we are also selectively active in the areas of autoimmunity, neuroscience and infection. To put ourselves in the best position to push the boundaries of science, we seek to leverage our combination of capabilities, which encompass both small molecules and biologics, and include immunotherapies and developing innovative delivery devices that can offer choice to patients. These are reinforced by a strong focus on personalised healthcare capabilities, which aim to match medicines only to those patients who will benefit from them. Our teams also work alongside the world’s leading academic and biotech research institutions to stimulate innovation and evaluate emerging technologies such as Modified RNA and CRISPR genome editing.

Sebastian Scheler

Innerspace GmbH

Innerspace helps leading pharmaceutical companies to train and assess cleanroom personnel more effectively, reducing errors and minimizing risks. Our solution provides a risk-based training methodology that draws on learning psychology and uses state-of-the-art virtual reality technology. Our training modules are aligned with the latest revision of Annex 1 and ensure compliance. By uniting expertise, we aim to minimize human error, resulting in risk reduction, cost savings, and quality assurance for your organization.

Caroline Dreyer

Novo Nordisk

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries.

Davide Codogna

Polpharma Biologics

Polpharma Biologics is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using patented solutions and state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas.

Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production preparing drugs for future commercial partnerships with global pharmaceutical players. The company’s expertise is in the development and manufacturing of medicines based on microbial and mammalian expression systems.

Matthias Mikkelsen

Watson-Marlow Flexicon

We’re Watson-Marlow Fluid Technology Solutions – part of Spirax-Sarco Engineering plc, a FTSE 100 Company. Spirax-Sarco Engineering plc is a world-leading thermal energy management and niche pumping Group. Every day we work to help our customers take on their toughest manufacturing challenges. We transform their production processes with components and entire systems that are responsive and predictive, producing technology used in the biotechnology, pharmaceutical, industrial, automotive, mining, food and beverage, OEM and medical device sectors. We have a presence in over 60 countries and provide comprehensive customer support globally.

Dr. Paul Matejtschuk

MHRA

The Medicines and Healthcare products Regulatory Agency, an executive agency of the Department of Health and Social Care, exists to enhance and improve the health of millions of people every day through the effective regulation of medicines and medical devices, underpinned by science and research. We deliver this through three distinct yet complimentary business centres: the MHRA regulatory centre, the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). With a range of interesting specialist opportunities on offer, with plenty of scope to develop your career within a leading and multifaceted scientific organisation, why not consider a career with us at our offices in central London or Hertfordshire.

Christian Scarpato

Merck

The Merck Group, branded and commonly known as Merck, is a German multinational science and technology company headquartered in Darmstadt, with about 60,000 employees and a presence in 66 countries. The group includes around 250 companies; the main company is Merck KGaA in Germany. The company is divided into three business lines: Healthcare, Life Sciences and Electronics. Merck was founded in 1668 and is the world’s oldest operating chemical and pharmaceutical company, as well as one of the largest pharmaceutical companies globally.

Micheal Dekner

Takeda

Takeda has been putting patients first for more than two centuries. We are a global, science-driven biopharmaceutical leader with headquarters in Japan and the U.S., guided by our Patient-Trust-Reputation-Business philosophy. This perspective represents who we are and guides how we act, helping us make decisions we can be proud of today and in the future.

 

As a member of our team, you’ll help deliver on our mission to strive for better health and a brighter future for people worldwide through leading innovation in medicine. It’s a responsibility that motivates and inspires us all.

You’ll find your own professional inspiration at Takeda, in the area that suits your interests and skills. Whether that’s R&D, Oncology, Corporate, Manufacturing, Quality, or another business unit, wherever you find yourself at Takeda, you’ll enjoy a meaningful career that’s making a positive impact on patients, people and the planet.

Benoit Franquin

CSL Behring

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.

Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

Julian Grossmann

Harro Höfliger GmbH

Harro Höfliger develops and manufactures production and packaging equipment as a hidden champion for customers around the world. We are an esteemed development partner for pharmaceutical and medical companies. Brand item manufacturers for consumer and home care products also trust in our highly specialized process solutions and services.

When it comes to new ideas and innovations, we don’t leave anything to chance. We work with our customers to ensure that we are always one decisive, innovative step ahead of the competition, even for niche products. This is how we create great things such as complete turnkey lines. Yet, in small things, we are unbeatable: As the technology leader, we set the standards for dosing powder in even the tiniest of quantities and for the most delicate of assembly processes.

Dr. Anne Orillo

Novartis

Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. Around 108,000 people of more than 140 nationalities work at Novartis around the world.

Djuro Raic

PLIVA

PLIVA is the largest pharmaceutical company in Croatia and one of the leading companies in Southeast Europe thanks to its highly competent employees, innovative technologies and continuous investments in production. PLIVA is also one of the major exporters in Croatia with over 80% of products intended for exports, and its major markets are Croatia, the USA and Russia.

PLIVA’s production portfolio includes a high number of finished dosage forms covering almost all therapeutic groups and active pharmaceutical ingredients. Focused on development of generic and niche products, PLIVA has the broadest portfolio of generic medicines in Central and Eastern Europe.

Jef Ceulemans

Organon

Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day.

Nigel Cryer

Bluciela LifeSciences

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More details:
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