ADC manufacturing

1
ADC Manufacturing
2
Background

• An antibody-drug conjugate (ADC) is formed by
  covalent biochemical conjugation of a monoclonal
  antibody with highly toxic payload drugs via a
  small molecular linker. ADCs are emerging
  candidates for targeted cancer therapies and due
  to the extreme toxicity of their payloads, ADCs
  are often considered as a new generation of
  highly hazardous and toxic pharmaceutical
  products. The unique nature of ADC presents
  challenges in its large-scale production. ADC
  manufacturing requires proper facilities that
  strictly follow the criteria and guidelines of
  cGMP-standard bio-macromolecule production.
  Whats more, these facilities are extremely
  stringent about aseptic production and they need
  to be operated under an occupational exposure
  limit (OEL) below 50 ng/m3.

3
ADC manufacturing
ADC manufacturing is a multistep process that can
be divided into three distinct stages cGMP
production of the antibody, cGMP synthesis of the
drug-linker complex, and conjugation to form an
ADC. The conjugated antibodies undergo extensive
purification and finished as ADC products upon
the completion of fill-finishing.
4
Content
cGMP antibody manufacturing
ADC conjugation, purification, and filling
cGMP organic synthesis
5
cGMP antibody manufacturing

• 01

6
cGMP antibody manufacturing
The cGMP antibody manufacturing service platform
has the capacity of pilot (535 L) to large scale
(gt 100 L) preparation of therapeutic antibodies
or recombinant proteins using various expression
systems (hybridoma, mammalian cell lines, insect
cell cultures, and microbial expression systems).
We also offer process development services under
this platform to help establish cGMP stable cell
lines, cell banking, upstream process
optimization, and downstream scale-up
7
cGMP organic synthesis

• 02

8
cGMP organic synthesis
This pipeline enables to prepare regular or
highly tailored linker molecules bearing
different release mechanisms, modifying payload
drugs for proper conjugation chemistry, preparing
new payload derivatives for the purpose of drug
development, and formulating the drug-linker
complex for ADC manufacturing.
9
ADC conjugation, purification, and filling

• 03

10
ADC conjugation, purification, and filling
ADC conjugation is achieved in cGMP certified
reactors after small-scale conjugation protocol
verification. The therapeutic impurities are
removed utilizing advanced filtering devices such
as ultrafiltration and tangential flow filtration
(TFF) systems. The ADC product are purified using
single-use chromatography systems and finished by
filling into aseptic vials via the cGMP sterile
filling pipeline.
11
THANK YOU