Revolutionary downstream bioconjugation method under development12 Feb 2018
New manufacturing paradigm will save 25% of total costs and the need for proteinaceous A & G resins.
ADC Biotechnology is developing a revolutionary, ‘downstream bioconjugation’ method that will present a new paradigm in Antibody Drug Conjugate (ADC) development and manufacturing. In contrast to the existing approaches – which undertake bioconjugation after both the mAb and cytotoxic have been manufactured – this new approach moves the conjugation step into the later stages of the downstream processing (DSP), with conjugation and antibody purification carried out concurrently.
“The major benefit, and the reason this approach will prove so disruptive, is that it will save several months of manufacturing time and up to 25% of the overall costs. But it will require much of the industry, with its current ingrained manufacturing methods, to reevaluate exactly how it structures the supply chain that often uses three CMOs,” commented Charlie Johnson, CEO of ADC Bio.
Using this ‘downstream bioconjugation’ approach, potentially means less time at the antibody manufacturer (i.e., less time in traditional downstream processing), with the remaining downstream processing and conjugation service both transferring to the bioconjugation CMO. The result is a refined, simpler and much more efficient system – saving up to 3 months of development time and resources plus creating large cost savings.
Under the company’s new process, the starting point for the conjugation will no longer be post-creation of purified antibodies and will instead begin with antibody supernatants. This persuasive approach forgoes the need for extensive chromatographic purification techniques to deliver purified antibody.
The company’s groundbreaking production technique – yet to be formally named –also removes the need for expensive Protein A resins, replacing them with capture resins that are at the heart of the company’s core ‘Lock-Release’ technology. In ADC manufacturing, the Protein A capture step is the most costly in downstream processing, delivering semi-purified antibody. Now, starting from antibody supernatant, ADC Bio’s unique approach will see their patented ‘Lock-Release’ technology facilitate both the antibody capture step and subsequent conjugation to the ADC payload – essentially replacing the Protein A resin and assembling the ADC in an efficient manner. The subsequent viral inactivation, removal and polishing will then occur post-conjugation.
The benefits of eliminating the need for proteinaceous A & G resins extends beyond substantial cost savings. Incidental leaching of these proteins from their purification media increases the impurities in a biopharmaceutical drug product – all of which have to be removed in subsequent chromatography polishing steps before an antibody can be used for any therapeutic application. Moreover, Protein A is known to cause immunogenic responses in humans and has proven toxic in a number of clinical studies – thus its removal is mandatory.
Johnson added: “In essence, we are telescoping antibody DSP and conjugation, providing just one set of analytical development and release processes, whilst bringing in the use of much more cost effective and safer resins. We have already successfully piloted our new development process in a number of applications. As the next step, we have just launched our Specialist Process Innovation Group – which will be responsible for fostering all further technological innovations moving forwards – with its first project being to validate our new downstream conjugation approach over the course of the next 18 months.”
Compact serialization-ready manual workstation
11 Aug 2018
A cost-effective and space-saving solution for serializing cartons and performing multi-level aggregation on cases and pallets.Read more
Oxford Genetics signs major supply and licensing agreement for CRISPR engineered mammalian cell lines
8 Aug 2018
Company moves away from manual processing in favour of automated, scalable platforms.Read more
BASF receives award for its portfolio of natural cosmetic ingredients
7 Aug 2018
Company recognised for its innovation and continual delivery of new natural ingredients.Read more
Extended distribution agreement enables customers to continuously improve their bioprocesses
6 Aug 2018
Agreement includes Pall's next-generation Kaneka KanCapA 3G sorbent for the primary capture of mAbs from clarified cell culture.Read more
A new era for migraine patients
6 Aug 2018
EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.Read more
Amgen breaks ground on next-generation biomanufacturing plant in Rhode Island
3 Aug 2018
The plant will be first-of-its-kind in the US.Read more
Croda invests in SiSaf’s novel bio-courier technology
3 Aug 2018
ProSilic will give Croda’s customers access to the next generation of targeted and controlled drug delivery.Read more
Breast cancer device receives FDA approval
3 Aug 2018
The first non-radioactive, dual-tracer for sentinel lymph node biopsy approved in the US.Read more
Building contingency plans for an ambiguous post-Brexit market
31 Jul 2018
One company's positive approach to Brexit preparations, despite the lack of definition.Read more
Cherwell publishes guide on environmental monitoring processes and validation
31 Jul 2018
Supporting EM programs in preparation for proposed EU GMP Annex 1 changes.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation