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Pharma and Biotech
Pharma and Biotech
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The development of Highly Potent Active Pharmaceutical Ingredients (HPAPI) is continually evolving. These customized, active ingredients are achieving remarkable success in oncology and enabling unprecedented advances in medicine.
For pharmaceutical companies, processing and filling highly potent active ingredients presents significant challenges: Small quantities require extensive containment efforts. We provide comprehensive support for these and other tasks with a safe, holistic process and complete turnkey solutions. Learn more about our many years of experience with aseptic filling systems for highly potent liquids and freeze-dried powders.
Highly potent active ingredients require special handling due to the risks associated with them. Hermetically sealed systems ensure complete separation between the operator and the processing area. Our expert explains the key features of these highly potent pharmaceuticals and the associated challenges in production.
Antibody-drug conjugates (ADCs), are a new technology that specifically attack cancer cells by combining chemotherapy with the selective effect of antibody therapy. ADCs are considered ground-breaking therapeutics, offering promising treatment options and sparing healthy tissue.
ADCs are highly potent and critical for the operator, as humans pose the greatest risk of product contamination. Therefore, the requirements for closed barrier systems are increasing. What equipment do we offer and how can we support you in filling ADCs? Our expert provides insights and presents solutions from Optima.
The potency level of HPAPI is developing dynamically, requiring even greater protection for employees. At the same time, regulatory requirements are becoming more stringent. The handling of highly potent active substances is regulated internationally in OEB (Occupational Exposure Banding) and OEL (Occupational Exposure Limits) classifications.
The limit values ensure that the health of the operator and the quality of the product are not impaired. HPAPI compounds fulfil the criterion of an OEL of ≤ 10 µg/m³.
Choose from different options to find the right cleaning concept for your easily accessible system. A simulation of your cleaning processes helps to arrive at the right design for you. Wash down can be either manual or semi-automatic. Alternatively, we can position automatic cleaning nozzles - completely individually according to your requirements.
The freeze-drying design also adapts to your highly potent APIs. First, safe and gentle handling of your containers during loading and unloading avoids any contamination. Second, filters in the suction line of the vacuum system safely discharge the highly potent exhaust air. Third, the system neutralizes potentially highly potent substances and, fourth, it uses vacuum pumps that can be flushed and decontaminated.
The processing of highly potent active ingredients requires seamless safety measures for people and products. To achieve this, the room and the machine must form a functioning overall system. We provide comprehensive guidance on pressurization and wastewater concepts as well as decontamination and containment.
We are your strategic turnkey partner for pharmaceutical packaging equipment - from development through the entire life cycle. Filling line, isolator, and freeze dryer come from a single source. We supply you with a fully tested system for an efficient production start.
When filling highly potent active ingredients, thorough external cleaning of the containers is essential to remove potential particle deposits. Our new external washing machine cleans vials, pre-filled syringes, and cartridges effortlessly. Safety first, quality always.
If systems for highly effective active ingredients are designed as a complete system, the safety of people and products can be maximized.
The market for antibody drug conjugates (ADCs) is currently experiencing rapid growth driven by technological innovation, strategic collaborations and expanded clinical applications. These targeted cancer therapies combine the precision of antibodies with the efficacy of chemotherapeutics, enabling targeted treatment of cancer cells while minimizing damage to healthy tissue. Here are some of the key trends shaping the ADC market.
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For the production of biologics and small molecules for oncology, the French pharmaceutical company Servier relies on a flexible multi-use complete system from Optima, including freeze dryer and isolator for highly potent products.
For pharmaceutical companies, the processing and filling of highly effective medicines is full of challenges: Small volumes and quantities require a great deal of effort to contain. Optima provides you with all-round support for these tasks, thanks to its integrated process and complete turnkey systems.
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