APR Nov/Dec 2022 - 31

« FORMULATION AND DEVELOPMENT
Air cleanliness
ISO 5 (Grade A)
ISO 7 (Grade B)
ISO 8 (Grade C)
Maximum # of airborne particles (/m3
Count under non-operating conditions
> 0.5 microns
3520
3520
352000
Table 1. ISO classifications of clean rooms12
)
> 5 microns
20
29
29000
Count under operating conditions
> 0.5 microns
3520
352000
3520000
> 0.5 micron
20
2900
29000
Pilot sterile
# of suites
Classification
Capabilities/output
Table 2. Ascendia's sterile and non-sterile processing and fill & finish capabilities
S1-Sterile
S2-large
Sterile
5 suite (with freeze
dryer) (PFS/Vial)
100/10,000
Up to 5,000 units
per batch
Size main processing area 1,000 sq. ft.
4 suite (PFS/Vial)
100/10,000
up to 24,000 units
per batch
1,500 sq. ft.
5 suite (Vial)
100/10,000
Up to 150,000 units
per batch
10,000 sq. ft.
complete automation. In addition, the lyophilization unit provides the
extended capacity of over 5000 vials for each freeze drying cycle.
Conclusion
Ascendia continues to play an important role as a specialty CDMO
in formulation development and cGMP manufacturing of complex
dosage forms such as lipid nanoparticles, liposomes, nanosuspensions,
nanoemulsions, and long acting injectables based on its proprietary
technologies: Emulsol®, Amorsol® and Nanosol®, leading to translation
of novel therapy modalities from discovery to clinical phases and
commercialization at a faster speed. Its state-of-the-art facility,
processing equipment and technical know-how in lyophilization,
aseptic processing, and sterilization under cGMP demonstrates its full
commitment to clients seeking support in human clinical trial supplies
and commercialization for oral and parenteral dosage forms.
References
1.
2.
3.
4.
5.
6.
7.
8.
# of suites
Classification
Capabilities/output
5 suites
100,000
Pilot batch size, up to
100,000 units per batch
Size main processing area 4,000 sq. ft.
9.
10.
11.
Non-Sterile Early
Phase I/II
Non-sterile2commercial
8
suites
100,000
>=100,000 units/batch
15,000 sq. ft.
A.M. Cundell, Justification for the use of aseptic filling for sterile injectable products, PDA J.
Pharm. Sci. Tech., 2014, 68, 323-333.
Terminal sterilization of pharmaceutical products, The Altascientist, Issue 21 (https://
www.altasciences.com)
FDA, " Guideline on Sterile Drug Products Produced by Aseptic Processing " (1987).
12. Guidance on the manufacture of sterile pharmaceutical products produced by terminal
sterilization, Chaired by M. Muroi and T. Sasaki (Japan, 2006).
13.
Considerations in Development & Manufacturing of Complex Injectables (www.
ascendiapharma.com)
Author's Biographies
J. Huang and S. Ali, Lipid nanoparticles, Drug Development and Delivery, https://drug-dev.
com/formulation-forum-lipid-nanoparticles-tackling-solubility-challenges-with-lipidbased-technologies-for-oral-injectable-formulations
C.
Molineaux et al., The Life Sciences Future - BioPharm Conference, Philadelphia, October
6, 2022
M. Le Bars, CDMOs on the rise, Contract Pharma, 2019.
D. Toops, Choosing and managing a CDMO, Contract Pharma, 2021 (Sept.)
L. Twose, Terminal sterilization for parenteral drugs: Finding the right CDMO Partner,
Phama's Almanac, October 2, 2018.
J. Agalloco, J. Akers, and R. Madsen, Aseptic Processing: A Review of Current Industry
Practice, Pharm. Tech., 2004, October, 126-150.
M. A. Kagg and J. Anant, Traditional vs closed single use sampling in aseptic pharmaceutical
manufacturing, Am. Pharm. Rev., 35(6), Sept/Oct., 2022.
EU GMP Annex 1: Manufacture of Sterile Medicinal Products (Draft), December 2020
Jim Huang is the founder and CEO of Ascendia Pharmaceuticals, Inc.
Dr. Huang received his Ph.D. in Pharmaceutics from the University of
the Sciences in Philadelphia (formerly Philadelphia College of Pharmacy
and Sciences) under Joseph B. Schwartz. He has more than 20 years
of pharmaceutical experience in preclinical and clinical formulation
development, manufacturing, and commercialization of oral and
parenteral dosage forms. Dr. Huang's research interests are centered on
solubility/bioavailability improvement and controlled delivery of poorly
water-soluble drugs through nano-based technologies.
Shaukat Ali joins Ascendia Pharmaceuticals Inc. as senior director of
scientific affairs and technical marketing after having worked in the
pharma industry for nearly 30 years. His areas of expertise include lipid
chemistry, liposomes, surfactants base drug delivery systems, SEDDS/
SMEDDS, oral and parenteral, topical and transdermal drug delivery,
immediate and controlled release formulations. He received his PhD in
Chemistry from the City University of New York and carried out his postdoc
training at the University of Minnesota and Cornell University. Dr. Ali has
published over 45 articles in the scientific journals and is inventor/coinventor
of several US and European patents. He is the recipient of IPEC's
Henk de Jong industrial research award and serving as a member of the
USP panel of expert for Excipient Test Methods committee.
www.americanpharmaceuticalreview.com |
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APR Nov/Dec 2022

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