PharmaCongress 2025 - Not only, but also Annex 1
The aseptic manufacture of medicinal products has undergone significant progress in recent years, both in terms of regulatory guidelines and technological developments. This has implications in a variety of areas of pharmaceutical manufacturing, quality assurance and quality control.
Updated guidelines
In August 2022, Annex 1 of the EU GMP guidelines for the manufacture of sterile medicinal products was comprehensively revised. The new requirements came into force on 25 August 2023 and aim to improve the sterility and quality of medicinal products. A specific section on freeze-drying and product transfer became mandatory by 25 August 2024.
Other guidelines relevant to certain types of aseptic manufacturing have also been updated. For example, the ADKA (Federal Association of German Hospital Pharmacists) is revising its guidelines on the ‘Manufacture and testing of medicinal products in hospital pharmacies’ from 2016 and on the ‘Aseptic manufacture and testing of ready-to-use parenterals’ from 2012. These updates are intended to meet the increased requirements for quality assurance and improve patient safety.
Technological developments
Technologically, the use of barrier isolators and restricted access barrier systems (RABS) has become established. These systems provide physical barriers between the product and the operating personnel, significantly reducing the risk of contamination. Isola tors ensure complete separation of the work area from the environment, while RABS allow controlled but less compartmentalised access. In the new Annex 1, isolators and RABs are more or less equated and corresponding systems are seen as a basic requirement for new authorisation. The separation of the aseptic process from the operator environment is practically mandatory.
New concepts, e.g. automated, gloveless isolators, are increasingly being considered, especially for small batches in the field of cell and gene therapy.
Impact on many levels
However, the implementation of stricter EU regulations does not only have an impact on technology and the manufacturing process. At least in the short term, the tightening of Good Manufacturing Practice (GMP) guidelines also led to production bottlenecks in some areas for essential medical solutions such as sterile saline solutions. Many manufacturers were unable to fulfil the increased requirements, which led to supply bottlenecks and delays in medical interventions.
To summarise, current developments in the field of aseptic manufacturing of medicinal products have both increased the quality and safety of products and created new challenges for manufacturers and healthcare facilities. Continuous adaptation to new guidelines and technological innovations therefore remains essential.
Recommendation
Wiesbaden, Germany8/9 April 2025
Single-Use Systems in Sterile & Biomanufacturing
Topics of the PharmaCongress 2025
The PharmaCongress 2025 and the accompanying PharmaTechnica will therefore also be dedicated to developments in classic subject areas such as aseptic technologies, isolators and barrier systems through to single-use systems. In addition, the industry event will also address ‘modern’ topics such as digitalisation and the use of artificial intelligence, the requirements for ATMPs and cell and gene therapeutics. Participants will have a total of eight conferences to choose from, between which they can also switch to individual presentations at any time.
The following two conferences are new to the PharmaCongress.
Medical Cannabis - Cultivation, Processing, Systems & Technology.
Two presentations at this conference will deal with regulatory requirements, one from the perspective of a GMP inspector and the other with current developments in the field of marketing authorisation.
- Challenges and experiences from current GMP inspections, Dr Rainer Gnibl, District Government of Upper Bavaria
- News from the German Cannabis Agency, speaker from the German Cannabis Agency (BfArM)
The conference will also cover the following topics:
Medicinal cannabis has become prescription-only in several countries around the world, creating a need for manufacturers to supply pharmacists and doctors with the newly legalised drug. But what is considered medicinal cannabis? And what aspects need to be considered for CBD products?
In the meantime, European Pharmacopoeia (Ph. Eur.) monographs have been created and implemented that describe the quality requirements for cannabis flowers (as API or for direct prescription to patients) and for cannabidiol (CBD).
In addition, the United States Pharmacopeia (USP) has recently issued several draft monographs for cannabis flower and CBD that include quality standards and testing procedures. These new standards aim to improve the safety, consistency and quality of canna bis products for medical purposes. The monographs address various aspects, such as the acceptable ranges for active ingredients, microbial contamination limits, testing for impurities and labelling requirements. The updates reflect an effort to ensure that cannabis products meet regulatory requirements, particularly for medical use. In addition, the revisions aim to align the quality standards for cannabis with those for other herbal medicines to support safe and effective use. In addition, the EMA's Guideline on good agricultural and collection practice (GACP) of starting materials of herbal origin is currently being revised. It is expected that the revised version will include specific requirements for indoor cultivation.
Recommendation
Barcelona, Spain23-25 September 2025
Modern Microbiology Laboratory
In order to simplify the worldwide distribution of medicinal cannabis, harmonisation of the pharmacopoeia monographs would be desirable. However, questions remain, because:
- There is currently no harmonised ‘EU GMP cannabis standard’ or ‘Global GMP/GACP standard’ for medicinal cannabis (active substance / herbal medicinal product).
- The Ph. Eur. Cannabis Flower and CBD monographs are currently not harmonised with the corresponding USP monographs (draft).
- With regard to the quality requirements for cannabis extracts (herbal medicinal preparation), only national monographs exist to date.
Therefore, in addition to EU GMP, national regulations, guidelines and pharmacopoeia monographs must also be followed and applied. The conference will therefore deal with the following topics in particular:
- GACP/GMP/GDP requirements for medicinal cannabis
- Experiences from recent GMP inspections
- Cultivation under GACP
- Requirements for drying
- GMP certification for export
- Planning of the facility
- Qualification/validation
- Case studies
- Lessons learnt
Cleanroom Challenges in Ongoing Operations
Even though RABS and isolators are playing an increasingly important role, classic cleanrooms are far from obsolete. With the exception of new buildings, existing production units with classic A in B cleanroom concepts are still frequently in use.
For this reason, the second new conference track at the 2025 congress will focus on the topic of cleanroom consumables and ongoing operations. This track will address the issues of cleanroom materials and their suitability, routine checks (e.g. monitoring) and questions of ongoing hygiene.
So-called ‘cent’ disposable items in the personnel area such as hoods, gloves, face masks or overshoes or in the production area such as cloths, wipe covers or associated products such as cleaning agents and disinfectants are often underestimated but important factors in ensuring the quality of the products manufactured. Incorrect selection or incorrect use can be the source of unwanted contamination with both particles and microorganisms.
This is why the congress addresses this topic. Experts will present the necessary criteria and requirements for the products used. Helpful guidelines for this area will also be presented and a GMP inspector will explain the expectations from an inspector's perspective.
Other topics relating to modern manufacturing:
European Aseptic Technologies - Annex 1 Conference
With the publication of the new version of the EU GMP guideline Annex 1 in August 2022, some requirements for the manufacture of sterile medicinal products have become significantly stricter or have been added. Their implementation often poses considerable challenges for companies. How inspectors interpret these new requirements and check them during inspections will be one of the focal points of the conference.
The implementation of (new) Annex 1 requirements in pharmaceutical companies is difficult in some cases. How do you deal pragmatically with Quality Risk Management (QRM) requirements in aseptic manufacturing; what do you expect when establishing a Contamination Control Strategy (CCS); what does the operational implementation of PUPSIT requirements for sterile filtration look like; how should Ready-To-Use (RTU) materials and their suppliers be re-examined with regard to compliance? What are the new requirements for supplier assessment and what does such an assessment involve from an inspector's perspective? Answering and discussing these questions will be another focus of the conference.
Ultimately, many of the new Annex 1 requirements must also be implemented technically in the companies. To this end, various case studies from international pharmaceutical companies such as Sanofi, Johnson and Johnson, Siegfried Hameln and Boehringer Ingelheim will be presented, which, in addition to technical implementation, will also look at new technological trends in the manufacture of parenterals.
Trends in Barrier Systems & Robotics
With the publication of the new EU GMP guideline Annex 1 in August 2022, new requirements have also been introduced in the area of barrier systems (RABS and isolator). Design requirements have been formulated, particularly with regard to the ‘first air principle’. Requirements for the cleanroom background have been tightened. Specific requirements for RABS (Restricted Access Barrier System) have been included for the first time, as have requirements for the glove test and for the decontamination process.
In some cases, these specifications require technical adjustments to the equipment and the cleanroom environment. New approaches such as the integration of robots into the barrier systems and the establishment of gloveless systems are increasingly finding their way into pharmaceutical production and are responses to the increased requirements for both hygiene and contamination safety.
As part of the ‘Trends in Barrier Systems & Robotics’ track, various case studies from large pharmaceutical companies will present currently realised approaches and solutions. The focus here is on decontamination processes (e-beam and H2O2 decontamination) and gloveless isolators.
Digitalisation & Artificial Intelligence
Digitalisation and the use of artificial intelligence can no longer be stopped in the pharmaceutical industry. Their use in the GMP environment promises to increase quality and efficiency as well as optimise processes. But every beginning is difficult.
Needs analyses and target definitions, data integration and data preparation and the selection of the right AI methods are just the beginning. After pilot phases, the integration and scaling of the solutions is next, and the involvement of employees should not be underestimated. In addition, there are regulatory frameworks and GMP requirements that often do not (or no longer) fit in with current technological developments, but still need to be taken into account. How do you deal with these conditions?
Several pharmaceutical companies have now launched their first projects and are presenting their results and experience reports as part of the ‘Digitalisation & Artificial Intelligence’ track at PharmaCongress 2025. What was the initial situation; which sticking points had to be solved in the projects and what lessons were learnt; questions upon questions with many interesting and exciting answers in the case studies presented.
The key note on the first day of the conference also belongs to this topic area:
- Artificial Intelligence (AI) in Manufacturing and Quality at Sanofi, Dr Maite Durrenbach, Chief Quality Officer, Sanofi
Single-Use Systems in Sterile & Biomanufacturing
This conference provides a comprehensive platform to learn about the latest developments and applications of single-use technologies (SUT) in pharmaceutical manufacturing. From biopharmaceutical manufacturing to sterile drug production, flexible and costeffective solutions will take centre stage.
Single-use systems offer enormous advantages, including significantly lower investment costs compared to stainless steel systems, shorter construction times and faster scalability, which is particularly essential for small batches and ATMPs. At the same time, the event offers the opportunity to deal with the regulatory challenges and practical issues of this technology.
The insights into current regulatory developments are particularly exciting, with GMP inspectors assessing the requirements for single-use systems and highlighting typical weaknesses. Scientific presentations will shed light on the innovative use of single-use products in upstream and downstream processes, formulations and fill-and-finish applications. The topic of quality assurance will also be covered in detail: From particle controls and leachable/extractable studies to ensuring sterility, participants will receive practical recommendations on how to use SUT effectively and safely. Case studies from leading companies such as Merck, Sanofi and BioN-Tech will illustrate how SUT can be successfully integrated into production processes and lessons learnt during implementation.
This conference will bring together experts from industry, academia and government to discuss key topics such as quality, scalability and risk management and present concrete solutions.
Advanced Therapy Medicinal Products
Advances in the development and manufacture of ATMPs mark a significant turning point in modern medicine. ATMPs include innovative therapies such as CAR-T cell therapies, stem cell therapies, viral vectors (AAVs, lentiviruses, adenoviruses), plasmid DNA technologies and tissue engineering. These pioneering approaches offer new perspectives for the treatment of serious and often incurable diseases. The increasing number of new approvals of such therapies (e.g. Casgevy: first CRISPR/Cas9-based gene therapy, Yescarta: CAR T-cell therapy as first-line treatment for patients with B-cell lymphoma) reflects the constantly growing potential of these products. Technological developments show that ATMPs will shape the future of personalised medicine and offer the only chance for certain diseases. Their development requires close collaboration between academia, industry and regulatory authorities to successfully bring the promising therapies of the future into clinical practice. In addition to these technological and machine advances, regulatory frameworks are slowly but steadily evolving. The European Pharmacopoeia has integrated two new chapters on cell and gene therapies (3186 and 5.34), which will apply in 39 European countries from 1 April 2025. These replace the previous chapter 5.14.
As the existing thinking needs to be changed and authorities and the automated solution approaches need to better address the product and its specifics, the following three presentations are among others in the ATMP Track of the PharmaCongress.
- Navigating the EMA process: key learnings from the submission of a TEMP, Dr Katja Aschermann, Astato
Regulatory approval by the European Medicines Agency (EMA) is a key milestone in ATMP development. Dr Katja Aschermann shares valuable experiences and the problems that arose during the approval process for a TEMP (Tissue Engineered Medicinal Product) and the communication with the authorities at the time.
- Industrial in vitro expression of bacteriophages and other proteins, Dr Patrick Grossmann, Invitris; Dr Frenk Smrekar, Jafral
Another breakthrough in biopharmaceutical production is cell-free expression. Dr Patrick Grossmann and Dr Frenk Smrekar demonstrate the advantages of this technology, especially for the production of difficult-to-express proteins such as bacteriophages. In their case study, they show how targeted technology transfers and the scaling up of production processes can be carried out in a timely and cost-effective manner. This technology offers enormous potential for the economical and flexible manufacture of biological products.
- From personalised medicine to flexible machine solutions, Vilma Methner, Optima
The importance of scalable and automated production is emphasised by Vilma Methner. She will present a fully automated production line for the manufacture of CAR-T cells. Her presentation illustrates how individualised products can be produced efficiently and standardised through the use of advanced machine solutions. Here, the machine has adapted to the production process.
The second key note deals with modern production topics:
- Pharmaceutical Manufacturing Reinvented: The 3D Printing Process and other New Technologies, Dr Ranjita Shegokar Sahoo, Chief Pharma Innovation Officer (CPO), DiHeSys
Sustainability/Green GMP
The congress will be rounded off by a two-day series of lectures on the topic of sustainability in pharmaceutical manufacturing and quality. Relevant changes to important regulations such as the Energy Efficiency Act (EnEFG) or the EU regulation on fluorinated greenhouse gases, as well as projects and strategies in the companies will be presented and discussed, including in the presentation Sustainability Strategy at Pekana by Dr Marius Beyersdorff and Gabriele Brutscher. Pekana is one of the winners of the Pharma Deutschland (formerly BAH) Sustainability Award.
To delve deeper into the topics mentioned, PharmaCongress 2025 offers you a total of 8 conferences, around 100 technical papers and an exhibition with around 120 exhibitors. You can find more details on the GMP PharmaCongress & GMP PharmaTechnica 2025 website at ww.pharma-congress.com.
About the Author
Dipl. Biol. Axel H. Schroeder has been working at CONCEPT HEIDELBERG since 2008 and is head of the microbiology department.
