For most of the developers, the production process of a biologic is typically under-estimated. Initially they are more focused in the cell line and in its optimization. Sometimes they forgot that the upstream process optimization typically also yields improvements and usually is one of the mayor bottlenecks for the transference to a clinical-stage (if its required) or for the commercial production.

At 53Biologics we are strongly convinced that assuring a robust, reproducible, commercially viable manufacturing process facilitates the success through the clinical development and for the commercialization.

Our facilities are specifically designed to identify and to address your production challenges accelerating the timelines for delivery.

Different fermentation scales from 1 to 500 liters, different reactors configurations: i.e. Agitated, Stirred, wave-induced motion bioreactors, etc…; different industrial solutions like glass, stainless steel, single-use bioreactors, etc… seems to be difficult to find a configuration that 53Biologics could not reproduce and we won’t stop there.

This flexibility has helped 53Biologics to develop a huge variety of processes adapting and developing a broad catalog of recombinant proteins (monoclonal, fusion, chimeric and fragment antibodies, biosimilars, enzymes, anticoagulants, vaccines, etc.) in a wide range of microbial expression systems such as bacteria (E. coli, Bacillus, etc.), yeast (Pichia, Saccharomyces) or fungi (Trichoderma, Aspergillus and the revolutionary C1 , etc.), mammalian expression systems such as CHO, HEK and insect cells like S2. Depending on the protein and process flexibility, each of these processes works differently better in only certain bioreactor configurations.

The upstream process development typically starts with a transference phase of the client’s base case production process, but sometimes the clients do not have an established process or its only at lab (i.e. flask) scale. Then, it is when the experience of 53Biologics represents a huge advantage. The experienced process development team could suggest a first base case for the further optimization that could save time and money for our clients. Only a process fine tune is required to adapt it to each protein of interest.

The effect to media composition, other fermentation parameters like pH or Temperature, mixing, oxygen transfer rates affecting parameters like pressure, aeration, air/oxygen supply, feeding of Carbon or Nitrogen sources, Inductor compounds, etc. and many other key performance indicators should be optimized during the upstream process development.  Lot of work could be done, a lot of room for improvements could be proposed, dozens of individuals batches but do not get lost into this labyrinth, the most important think is pursuing the quality or manufacturing cost of your product of interest. 53Biologics will lead you through the best lean strategy to diagnose the room for improvement and industrialize your upstream process.

During the Upstream process optimization, 53Biologics would be also your analytical partner for the establishment and validation of the most suitable In-Process Control (IPC) methodologies. In-process control (IPC) methods are an essential part of the quality control (QC) strategy during the manufacturing process.

For 53Biologics a waiting list is one of the most affecting points to these kinds of developments. For this reason, our upstream development projects typically start in a very short notice, typically in less than 2-3 weeks from an agreed scope of works (just the time required to acquire the needed compounds and only if they are not in our stock).

For preclinical drug development, 53Biologics compiles all the information required to fulfil the CMC section of the IMPD, expediting transfer to manufacturing.