Applications and Repligen BioProcessing Technology
Identify your application from the left hand column then click on the corresponding
product to find out how our products can help.
Repligen's Immobilized Protein A resins -- IPA or CaptivA™ PriMAB range -- offer attractive value propositions for a variety of customers. With good binding capacity at typically acceptable flow rates CaptivA™ now provides users of Protein A an economically effective option for both single or multi-use applications. CaptivA's strong value proposition enables the user to consider discarding the resin after a few cycles or even after a single use thus avoiding space consuming storage and extensive valiated CIP practices.
Most monoclonal antibody purification processes consist of two or three chromatographic steps, generally with Protein A capture as the first step. Repligen's CaptivA™ Affinity Resins have been designed to provide a cost effective option for this initial critical chromatography step.
Selection criteria are often different for resins chosen for early stage process development versus later stage development. CaptivA™ PriMAB is an economically compelling option for early stage development, particularly if the final process is expected to be smaller scale or will use single use technology. Manufactured under an ISO9001: 2008 quality system and with an available Regulatory Support File, CaptivA™ PriMAB can continue to be used throughout larger scale processes up to and including commercialization.
Recent bioprocessing industry conferences and publications have featured discussions focused on the downstream purification bottleneck and reducing the cost of monoclonal manufacturing in industrial scale operations. Cost of ownership calculations for a Protein A capture step are complex and need to take into account the annual amount of protein required and fermentation capacity (yield and reactor size), which in turn dictates the number of times a process will be run. Consideration for batch size (liters and kgs), desired run time and Protein A resin performance enables calculation of the size and number of cycles of a Protein A capture column. Resin capacity performance impacts the initial resin investment cost and follow on column capital, foot print buffer and CIP costs. In regularly run large scale processes, users often require significant cycling and cleaning of resins, and can get very good economics from the highest cost most reusable resins. BUT what if a process is run at a much smaller scale with far fewer cycles? This will dramatically impact the economic viability of more expensive Protein A resins. In LIMITED CYCLE RESIN USAGE situations such as process development, clinical batch manufacturing, single use/disposable platforms and smaller commercial processes, CaptivA™ PriMAB offers an attractive value proposition.
Contract Manufacturers operate multi-product facilities that by their very nature have a limited number of production batch purification cycles. CaptivA™ PriMAB, is an excellent value proposition for a CMO conducting process development, clinical batch manufacturing, smaller scale or limited campaign process cycles. With good binding capacity at typical working flow rates, users may tailor resin cost and performance to an economic production objective.
Ex-vivo diagnostic antibodies are essential for diagnostic assay applications. Our Immobilized Protein A resins are a high quality alternative to other high cost Protein A resins for these often infrequent and smaller scale purification processes.
Conduct bench scale purifications or immunoprecipitation of research antibodies with our recombinant Protein A affinity resins, available in a range of bottle sizes tailored to the volumes needed for R&D experiments.
For over a decade the industry has been innovating and adopting more single use manufacturing technologies, from tank liners to buffer bags to disposable bioreactors. Single use technology, now well accepted, offers benefits such as reduced cleaning costs, validation activities, water usage, facility size and environmental footprint. Economically viable single use chromatography technology solutions have been limited –UNTIL NOW!
Repligen BioProcessing's Opus™ Run Ready pre-packed columns offer:
- Reliability, Reproducibility & High Performance: Automated compression packing combined with proven chromatography column design ensures reproducible packing and column flow properties that deliver excellent asymmetry and plate count.
- Cost Effectiveness: The simplicity of design and packing makes the Opus™ Run Ready pre-packed columns very cost effective. In combination with carefully chosen chromatography resins like Repligen's CaptivA™ PriMAB even Protein A can be applied cost effectively to SINGLE OR LIMITED CYCLE CAMPAIGN USE.
- Broad Capability: Repligen BioProcessing will "custom pack" any manufacturer's resin in the open platform Opus™ columns. Opus™ Run Ready columns have demonstrated functionality with a wide range of resins including affinity, HIC, SEC, IEX and MM.
Monoclonal Antibodies: Process Development & Manufacturing
Contract Manufacturing Organizations (CMO)
The key drivers for pre-packed column technology are convenience, process consistency and in some cases disposability. Automated pre-packing of columns ensures that even the most difficult resins can be packed routinely to a qualified protocol (packing study) with the knowledge that the pre-packed columns will have reproducible performance [asymmetry and plate count]. Consider the benefits of Repligen BioProcessing Opus™ Run Ready Pre-packed columns. Reduce or eliminate resource preparation time and costs associated with making packing buffers and resin slurries, repair, maintenance, cleaning and preparing columns, then packing and unpacking and packing again!
In process development, a matrix of test columns is typically prepared that covers a broad range of resins for different process steps. Whether for process development or scouting applications, pre-packed columns are an easy, cost effective solution. The primary arguments for pre-packed column technology are convenience and process consistency. Automated pre-packing of columns ensures that even the hardest to pack types of resins can be packed routinely to a qualified protocol (packing study) with the knowledge that the pre-packed columns will have good, reproducible performance [asymmetry and plate count].
Vaccine manufacturers have long been at the forefront of single use technologies. Many vaccines are manufactured in small, often infrequent batches where cleaning and column storage are a real problem. Add concerns with respect to cross contamination and the potential for immunological reaction and even the larger vaccine manufacturers are interested in implementing single use technologies. For a decade or more the industry has been innovating and adopting more and more single use manufacturing technologies, from tank liners to bags to disposable bioreactors. The benefits offered by single use technology have resulted in reduced cleaning costs, reduced validation activities, reduced water usage, reduced facility size and smaller environmental footprint. Only chromatography has no easy, economical single use solution – THAT IS UNTIL NOW!
In research, small scale pre-packed columns make preparative purification convenient and easy especially when a matrix of test columns need to be prepared that cover a broad range of resins for different process steps. Whether for preparation, development or scouting applications pre-packed columns are an easy, cost effective solution. The primary arguments for pre-packed column technology are convenience and process consistency. Automated pre-packing of columns ensures that even the hardest to pack types of resins can be packed routinely to a qualified protocol (packing study) with the knowledge that the pre-packed columns will have excellent and reproducible asymmetry and plate count.
Monoclonal Antibodies: Process Development, Manufacturing
Product Quality and Contaminant Monitoring – Leached Protein A
Our Protein A detection ELISA kits are designed for in-process monitoring and final product testing in a wide variety of antibody preparations. It has been developed for those customers who require a highly sensitive assay to measure small amounts of contaminating Protein A in antibody products. The combination of a unique and highly specific capture system and an optimized sample diluent yields a highly sensitive assay able to accurately detect Protein A in the presence of antibodies.
Testing for Protein A contamination occurs in several different phases of development and commercial manufacturing:
- Process development for leaching characteristics of the resin under specific conditions
- Manufacturing, typically from eluted samples taken throughout several points in the purification process
- Finish product release to document process containment levels and lot-to-lot consistency
Limits for leached Protein A in process development and monitoring samples are typically set internally but limits for finished product release are given by the FDA (please contact FDA for guidance).
Although the USP does not recommend a specific commercial kit for Protein A ELISA detection, Repligen's leached Protein A assays are chosen by global biopharmaceutical companies for their easy to use procedure, quick run time and accurate results. Our commercially available kit reduces assay development time and resources required for in-house assay development. In addition, Repligen is the provider of two separate kits, one for the detection of native and recombinant Protein A and another for the detection of GEHC's MabSelect SuRe™ ligand. For the most accurate results, standards and spiking proteins should match the contaminant ligand.
Many biotech companies that outsource downstream manufacturing of their therapeutic products also outsource leached Protein A testing. Expand your service offering by incorporating leached Protein A testing services for process monitoring and finished product testing.
Diagnostic Antibodies, Laboratory Research, Bench Scale & Assay Applications
Protein A Purification Products
Protein A ligands are routinely used in research laboratories for bench scale experiments and new purification product development as well as the manufacture of diagnostic assays. There are many sources of Protein A ligands - many are very expensive especially when purchased in small quantities, while others may not provide the requisite quality of manufacturing. Repligen BioProcessing recombinant Protein A meets the highest manufacturing, quality and purity standards and because of our experience and expertise in developing high yielding systems it is very competitively priced whether your requirements are for mgs or kgs.
If you need expert advice on ligand selection, performance or even the contract development and manufacturing of a specific variant, Repligen has been making Protein A variants for over 20 years. Ask us how – Discover the Source!