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Peptide NCEs and Generics
Development and Manufacturing
CGMP
With more than a decade of committed service to the peptide industry, CPC Scientific is a trusted provider of high-quality peptides to researchers and pharmaceutical companies all over the world. The CPC Group is comprised of peptide experts who have actively pursued peptide design and large scale manufacturing for more than 30 years, so your project is in good hands.
CPC Scientific is the ideal peptide partner for all of your CGMP needs, from concept to commercial.
CONTENTS3 INTRODUCTION
4 CGMP OVERVIEW
6 GENERIC PEPTIDES
7 DMF SCHEDULE
9 CERTIFICATIONS AND AUDITS
10 MANUFACTURING CAPACITY
11 MANUFACTURING EQUIPMENT
12 QUALITY PROGRAM
14 PARTNERING WITH CPC SCIENTIFIC
16 PEPTIVAC™ NEOANTIGEN PEPTIDES
17 CGMP PRODUCT CITATIONS
19 CONTACT INFORMATION
THIS IS THE LAST PEPTIDE BROCHURE YOU’LL NEED TO REVIEW.No matter the stage or scale of your project, CPC Scientific has the facilities and proven experience to meet your needs.
We invite you to review empirical evidence in the pages ahead. We welcome your closest scrutiny because, frankly, if we meet our own exacting standards, we stand ready to take on the scientific world.
If you have any questions, please feel free to call a consultant at:
(408)734-3800Toll-Free:
(877)272-7241
cpcscientific.com3
Analytical Method Development and Validation | Quality Assurance & Regulatory support
• SPPS, LPPS, ligation chemistry and fragment condensation methodologies
• All protecting strategies (Boc, Fmoc, Cbz) can be used
• Innovative purification and isolation techniques employed
• Process development and scale-up competence insures a robust commercial process
• Complex sequences and peptide modifications adapted to large-scale production
E X P E R T I S E
COMPLETE PRODUCT LIFE-CYCLE SUPPORT
OVERVIEW
PROCESS SCALE-UP PROCESS VALIDATION
COMMERCIALMANUFACTURING
DiscoveryCommercial
PhaseClinical
Phase IIIClinical Phase II
Pre-Clinical Phase
Clinical Phase I
PROCESS DEVELOPMENT
US-BASED CGMP PROJECTSBY CLINICAL TESTING PHASE
0 5 10 15 20 25 30 35 40
Phase I
Phase II
Phase III
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G E N E R I CP E P T I D E SCPC Scientific offers a variety of generic peptides for use as active pharmaceutical ingredients (APIs), which are utilized in the treatment of various diseases including cancer, diabetes, obesity, and multiple sclerosis. Our CGMP manufacturing facility employs a rigorous quality and EHS system to insure global compliance, including the stringent requirements of the United States, European Union, China, and Japan.
In addition, we fully support our pharmaceutical customers with required regulatory documentation including Drug Master Files (DMFs).
NAME SEQUENCE/INDICATION DMFLeuprolide Acetate
pGlu-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt | Indications: Prostate Cancer, Endometriosis, Uterine Leiomyomata, Precocious Puberty, Breast Cancer.
MFDS: 2018/04US FDA: 2015/04CFDA: Approved in 2009
Triptorelin Acetate
pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH2 | Indication: Hormone-responsive cancers such as prostate cancer or breast cancer, Precocious Puberty, Estrogen-Dependent Conditions (e.g., Endometriosis or Uterine Fibroids), Assisted Reproduction.
CFDA: 2014/03CFDA: Y20170001090
Exenatide Acetate
H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2 | Indication: Diabetes.
CFDA: 2015/12CFDA: Y20170001378
Terlipressin Acetate
H-Gly-Gly-Gly-Cys-Tyr-Phe-Gln-Asn-Cys-Pro-Lys-Gly-NH2 (disulfide bridge) | Indication: An analogue of vasopressin, BLeeding Esophageal Varices, Septic Shock, Hepatorenal Syndrome, cardiovascular (low blood pressure.).
EMA: 2019/09CFDA: 2019/09
Cetrorelix Acetate
Ac-D-Nal-D-Cpa-D-Pal-Ser-Tyr-D-Cit-Leu-Arg-Pro-D-Ala-NH2 | Indication: IVF. CFDA: 2019/08
Triptorelin Pamoate
pGlu-His-Trp-Ser-Tyr-D-Trp-Leu-Arg-Pro-Gly-NH2 | Indication: Endometriosis, Uterine Fibroids, Premature Puberty. Symptoms of Prostate Cancer and ART.
CFDA: 2020/03
Teduglutide H-His-Gly-Asp-Gly-Ser-Phe-Ser-Asp-Glu-Met-Asn-Thr-Ile-Leu-Asp-Asn-Leu-Ala-Ala-Arg-Asp-Phe-Ile-Asn-Trp-Leu-Ile-Gln-Thr-Lys-Ile-Thr-Asp-OH | Indication: Short Bowel Syndrome.
CFDA: 2020/08
Degarelix Ac-D-2Nal-D-4Cpa-D-3Pal-Ser-4Aph(L-Hor)-D-4Aph(Cbm)-Leu-Lys(iPr)-Pro-D-Ala-NH2 | Indication: Prostate Cancer.
CFDA: TBD
Buserelin Acetate
pGlu-His-Trp-Ser-Tyr-D-Ser(tBu)-Leu-Arg-Pro-NHEt | Indication: Prostate and Breast Cancers.
CFDA: TBD
Liraglutide Acetate
H-His-Ala-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys(γ-Glu-palmitoyl)-Glu-Phe-Ile-Ala-Trp-Leu-Val-Arg-Gly-Arg-Gly-OH | Indication: Diabetes (type II).
CFDA: 2020/02
DMF SCHEDULE
BROWSE OURPEPTIDE CATALOG
www.cpcscientific.com
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CERTIFICATIONS AND AUDITS
• FDA (US): Audited
• EMA (EU): Audited
• MFDS (Korea): Audited
• NMPA (China): Audited
• ISO 9001 Certified
• ISO 13485 Certified
CGMP COMPLIANCECPC’s CGMP program strictly adheres to CGMP guidelines including:• Code of Federal Regulations Part 210/211 (21
CFR 210/211)
• ICH Q7 (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7)
We were the FIRST peptide CMO in Asia to be inspected by the
U S F D A
4 USFDA INSPECTIONSNO FORM-483 OBSERVATIONS
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MANUFACTURINGCAPACITY
• 750,000 sq. ft. CGMP Manufacturing space
• 17 CGMP Peptide Synthesis Suites by 2019
• CGMP batch sizes from gram scale to multi-kilogram scale (20kg/batch)
• Qualified air and water systems
• IQ, OQ, PQ qualified equipment
• Class 100K and 10K clean rooms
Large-Scale CGMP Manufacturing Equipment
0 5 10 15 20
Tray Lyophilizer: 1,000L
Tray Lyophilizer: 500L
Tray Lyophilizer: 150L
30" Column
20" Column
12" Column
Reactors: 500L
Reactors: 200L
GMP Peptide Synthesis Suites
Now End of 2019 Neoantigen Suites
C
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QUALITYPROGRAM
• Appearance: white to off-white solid
• Solubility: Clear solution at a predefined concentration
• Purity (HPLC, UPLC): 95-99% specific to phase of development
• Molecular weight (MS)
• AAA (Amino Acid Analysis): ±10% of theoretical
• Peptide content: ≥70%
• Counter-ion content
• Moisture content (Karl Fisher): ≤10%
• Residual Solvent Content: GC-MS
• Residual trifluoroacetic acid: ≤0.1%
• Bioburden: Report Aerobic and Spore Count, USP guidelines
• Endotoxin: Report LAL (Gel Clot), USP guidelines
• Elemental Analysis (ICP-MS): Report results for the following metals: Sb, As, Bi, Cd, Cu, Pb, Hg, Mo, Ag, SnOu
r CGM
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:
• Phase appropriate control systems consulting
• CMC compilation• DMF compilation and
submission• Annual product reviews
• Batch record review• Document management & control• Deviations/Investigations• CAPA follow up and tracking• Complaint management• Product release
QUALITY ASSURANCE REGULATORY SUPPORT
• In-process, release and environmental control testing
• Standard release testing performed in-house
• Audited contract laboratories available for additional testing
• Method development and validation, formal method transfer
• Stability studies (ICH) and forced degradation
A dedicated, in-house Quality Department verifies full CGMP compliance throughout production, as well as testing and documentation standards in accordance with the most stringent FDA requirements.
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CPC provides all required regulatory support for your peptide APIs:
• Phase-appropriate consulting and control systems
• Information necessary for chemistry, manufacturing, and controls (CMC) compilation for Investigatory New Drug (IND) and New Drug Application (NDA) submissions
• Drug Master File (DMF) compillation and submission
• Annual product reviews
REGULATORY S U P P O R T
OUR EXPERIENCE IS AT YOUR DISPOSAL
YOUR SUCCESS IS OUR SUCCESS. Your dedicated contacts will know your project as
well as you do, and they’ll keep you in the loop.
PARTNERINGWITH CPC
Research & Development • ProductionQuality Control • Quality Assurance • Logistics
Founded in 2001, CPC Scientific is a globally-recognized CDMO. The CPC Group is comprised of peptide experts who have actively pursued peptide design and largescale manufacturing for more than 30 years, so your project is in good hands. We work directly with leaders in the biotechnology and pharmaceutical industries to help bring life-changing therapeutics and diagnostics to market.
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ASY*-FITC was synthesized using good manufacturing practice (GMP) methods (CPC Scientific, Inc.). Stability was evaluated on high-performance liquid chromatography (HPLC) and mass spectrometry. Aliquots of peptide (0.8 mg) were stored at −20 °C as lyophilized powder in single-use amber vials for protection from light.”
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Joshi, Bishnu P., et al. “Multimodal endoscope can quantifywide-field fluorescence detection of Barrett’s neoplasia”. Endoscopy 48.02 (2016): A1-A13.
“SCIENCEVSCANCER
WITH THESE CHALLENGES IN MIND, WE’VE LAUNCHED OUR PEPTIVAC™ NEOANTIGEN MANUFACTURING PLATFORM.
The individualized nature of neoantigen immunotherapy requires 10-30 CGMP-grade peptides designed and produced for each patient. This process represents a significant paradigm shift in the need for multiple unique peptide sequences, the rapidity of synthesis, quality control, and prompt release.
SPEED MATTERS.Most projects complete in3-4 WEEKS
• 3 Dedicated Neoantigen CGMP Suites
• Rapid Manufacturing, QC, & Release
• Most Projects Completed in 3-4 Weeks
• Affordable Pricing for small-scale CGMP projects
• Automated & Manual Synthesis
• Flexible & Adaptable Synthetic Approaches to Improve Success Rate
SPEED+PRECISION=PEPTIVAC™
NEOANTIGEN PEPTIDE PRODUCTION WITH CPC SCIENTIFIC
To reach a neoantigen specialist, email:
Sales@CPCscientific.com
Nakagawa, Mayumi. “Recall Antigen for Promoting T-Helper Type 1 Response.” U.S. Patent Application 15/552,285, filed February 15, 2018.
Nakagawa, Mayumi. “Hpv e6 protein t cell epitopes and uses thereof.” U.S. Patent Application No. 14/566,604, filed August 13, 2015.
Saenz, Rebecca, et al. “TLR4-dependent activation of dendritic cells by an HMGB1-derived peptide adjuvant.” J Transl Med 12 (2014): 211.
Wang, Xuelian, et al. “Candida skin test reagent as a novel adjuvant for a human papillomavirus peptide-based therapeutic vaccine.” Vaccine 31.49 (2013): 5806-5813.
Sturm, Matthew B., et al. “Targeted imaging of esophageal neoplasia with a fluorescently labeled peptide: first-in-human results.” Science Translational
and many more...
CGMP CITATIONS
1716
1245 Reamwood Avenue Sunnyvale, CA 94089
In mid-2019, we’ll be moving to:160 East Tasman Drive, Suite 200
San Jose, CA 95134
408-734-3800 toll-free: 877-272-7241
CPCScientific.com sales@cpcscientific.com
WE LOOK FORWARDTO WORKING WITH YOU.
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