The flexible approach to modern large & small molecule manufacturing
Kate Buggle , strategic business development director , and Will Sanders , senior director of R & D , at Actylis , introduce a new paradigm in biopharma manufacturing
With rising interest in cell and gene therapies ( CGTs ) for diseases ranging from cancer to inherited diseases and the growing need for vaccines , biopharma companies are increasingly looking to suppliers to offer flexible solutions for their drug development . Similarly , with the increasing number of small molecule drug delivery formats , customised and tailored raw materials are in increasing demand .
Whether constrained by physical space , requirements for higher titers , lack of resources or a preference for lean operations , the economics of make-or-buy , when it comes to many large and small molecule materials , is leaning towards ‘ buy ’. Growth in CGTs , as well as changes in the small molecule market , have made the production and use of these materials more specialised and more challenging .
Buffer production
As a result , large and small biopharmaceutical companies alike are relying on third parties to develop and source many of their critical raw materials . Buffers , for example , are an important element in the production of therapeutics , but keeping production in-house comes with associated capital and labour costs .
While buffer production may seem like a straightforward process , it is becoming one best managed by specialists . As production techniques shift and new therapeutic classes like CGTs become more common , having a trusted partner to guide development and testing of all the buffers needed for each unique drug formulation can provide a more efficient manufacturing process .
For example , over the past few years , many biopharmaceutical companies are producing higher titers of their therapeutics , which can create potential problems in downstream purification and require more buffers . CGTs are an even greater challenge , often requiring 25 to 30 different buffers incorporated into a single process . This is far from the core expertise of most drug developers .
Some key considerations for biopharma companies are the physical space required for mixing tanks to produce buffers , as well as to store the raw materials needed to make them and the finished buffers before use . Keeping buffer production in-house can easily add 20 % or more to a company ’ s physical footprint . For many , especially start-ups , floorspace is at a premium and is probably better devoted for lab space or other core functions .
In-house buffer production can also bottleneck a facility . Producing 1,000 kg / year of bulk drug substance
requires 1.5 million litres of buffer for purification , which slows production .
In addition , the logistics of raw material sourcing and coordinating production of a broad array of buffers is complex and requires both manpower and capital . A custom buffer supplier-partner can work with the internal production team to understand their production schedules , determine buffer consumption levels and manage justin-time deliveries , reducing storage space and preserving capital .
CGT challenges
A 2020 McKinsey & Company market report showed that there are increasing clinical and preclinical development activities in CGTs . However , it also noted that the largest 20 biopharma companies accounted for only 15 % of launched CGTs , 13 % of clinical programmes and 4 % of
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