company presentation -...
TRANSCRIPT
COMPANY PRESENTATION
‹Nr.›
LEADER IN PEPTIDES SINCE THE 1970’s
• Dedicated to peptides
since its establishment
in 1971
• Working on a global
scale
• Public company since
1998 (Swiss Stock
Exchange)
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OUR BUSINESS PARTNERS
% of Sales
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OUR BUSINESS
APIs Generic peptide and
small molecule APIs,
development and
manufacturing of NCEs
Research Chemicals Custom synthesis
Catalog products
SALES REVENUES IN 2014: 183.9 MILLION CHF
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HIGHLY TRAINED EMPLOYEES
Over 790
employees
STRONG COMMITMENT TO TRAINING
GMP sites
THE BACHEM GROUP
Bachem Europe
Bubendorf, CH
Vionnaz, CH
St. Helens, UK
Weil am Rhein, DE
Bachem Americas
Torrance, US (CA)
King of Prussia, US (PA)
American Peptide
Company
Sunnyvale, US (CA)
Vista, US (CA)
BACHEM LOCATIONS
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SUNNYVALE (CA)
VISTA (CA)
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BACHEM AG BUBENDORF, SWITZERLAND
API development and manufacturing (cGMP) & production of research
chemicals (catalog products, custom synthesis) by solid-phase peptide
synthesis (SPPS) and solution phase chemistry
For SPPS
• Annual capacity of over 500 kg
• 1000L (stainless steel) and
75L / 150L (glass) reactors
For solution phase
• Annual capacity of hundreds of kg
• 100 L / 250 L / 630 L reactors and
1000 L reactor
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BACHEM IS YOUR TRUSTED PARTNER
Research & Development:
• Catalog peptides and custom synthesis services
Custom Manufacturing
• Process development and validation
• Production of peptides for preclinical and clinical phases
Commercial supply
• Supply of (multi-) kilograms to tons of cGMP API (launch
quantities, manufacturing of API for marketed drugs)
• peptide and small molecule generics
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PIONEERING THROUGH CONTINUED INNOVATION
No. of amino acids
Year
1978
Thymopentin
1993
Calcitonin
2003
Aprotinin
2013
Interferon β-1a
1989
Goserelin
BA
CH
EM
– fo
un
de
d in
19
71
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OUR PORTFOLIO OF PRODUCTS AND SERVICES
BACHEM PIONEERING PARTNER FOR PEPTIDES
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CATALOG PRODUCTS
RESEARCH INSTITUTES, UNIVERSITIES AND
INDUSTRIAL R&D
Product portfolio of over 6500 catalog peptides and biochemicals at shop.bachem.com
• Research and bulk quantities
available from stock (mg to kg)
• Peptides, amino acid derivatives,
inhibitors, substrates, resins, linkers,
reagents
Easy ordering
& fast delivery
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CUSTOM SYNTHESIS
HEALTHCARE, BIOTECH, AND PHARMACEUTICAL
COMPANIES
• Peptide synthesis from mg/g to kg
scale
• Development of synthetic routes for
scale up
• Cosmetic & diagnostic peptides
• High quality and timely delivery
Dedicated site
for Custom
Synthesis
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OUR TEAM IS EXPERIENCED IN A LARGE SELECTION OF
MODIFICATIONS
N- and C-terminal Modifications
Backbone Modifications
Non-natural Amino Acids
Glycosylation
Lipidation
Methylation
Phosphorylation and Sulfation
Cyclic Peptides
Multiple Disulfide Bond Formation
Maleimido and Clickable Peptides
Hydrocarbon-Stapled Peptides
Branched Peptides
MAP Peptides
Depsipeptides
Peptidomimetics
LABELING AND CONJUGATION
Biotinylated Peptides
Dye Labeling
Heavy Isotope Labeling
FRET or TR-FRET Peptides
Pegylated Peptides
Conjugation to Imaging Agents
Conjugation to Proteins (BSA, KLH)
Conjugation to Oligonucleotides
“We’re very pleased with Bachem’s
services. Their employees are
extremely knowledgeable.”
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CUSTOM DEVELOPMENT AND MANUFACTURING OF NCEs
BIOTECHS AND PHARMACEUTICAL COMPANIES
• Development and manufacturing of APIs
from early clinical trials to
commercialization
• Process development, optimization and
validation
• Quality by design
• Sterile fill & finish for clinical trials
(Clinalfa®)
• Production of launch quantities
Our
project team is
your proactive
partner
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OUR PIPELINE OF CUSTOMER NCE PROJECTS
DEVELOPMENT & VALIDATION
• Product characterization
• Development and validation of
analytical methods
• Stability studies
• Identification of impurities
cGMP SYNTHESIS OF APIs
• For all phases of clinical trials
• Commercial supply
Over
150 NCE
projects
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REGULATORY AFFAIRS SUPPORT
• Consultation with customers
• Compilation of CMC documentation for IMPD/IND
• Support for regulatory requests
• Global submission experience: preparation, filing, updating of DMFs
Numerous CMCs have been
submitted in support of
successful applications of our
partners
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PROJECT MANAGEMENT
• Coordinates project activities
• Monitors project objectives and progress
• Facilitates direct customer interactions with Bachem experts
• Provides regular and timely project updates
We manage your project in
close collaboration with you
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CLINALFA®
STERILE PEPTIDES FOR CLINICAL RESEARCH
Clinalfa® Basic
• Vials of sterile freeze-dried products
• Used as controls when investigating
new peptide drugs, particularly for
metabolic, neurologic, and cardiac
indications
Clinalfa® Plus
• NCEs supplied as sterile freeze-dried
or ready-to-use liquid formulation
vials for clinical trials
Clinalfa® products are released by a Qualified Person.
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GLYCOSYLATION – OUR NEW SERVICE
Advantages of Glycosylation of Peptide Drugs
• Increased half-life, providing extended
dosing duration
• Better solubility, enabling improved
formulation properties
• Improved response to therapy
• Increased drug tolerance
Human follicle-stimulating hormone, a 92 amino
acid glycopeptide.
PDB: 1FL7
Fox, K.M., Dias, J.A., Van Roey, P. (2001) “Three
dimensional structure of human follicle-stimulating
hormone”, Mol. Endocrinol.15: 378-389
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BACHEM AND GLYTECH
Two pioneers in their
respective fields
collaborating to
advance
innovation in drug
development
The complex chemical synthesis of
Interferon β-1a was adapted to cost-
effective industrial-scale
manufacturing.
Interferon β-1a is a glycosylated 166 amino acid
protein and an approved drug substance to treat
multiple sclerosis with a world market of more than
$ 4 billion. There are currently three recombinant
products on the market which are mixtures of at least
10 glycoforms.
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PIONEERING PARTNERSHIP BACHEM AND GLYTECH
The partnership between Bachem and GlyTech is focused on
the chemical development and manufacturing of glycosylated
peptides.
Bachem has the proven expertise to scale up and
manufacture kilogram scale peptides. GlyTech is capable of
producing glycans in kg amounts by a proprietary technology.
«The selective chemical glycosylation at large scale has the
potential to be applied to a variety of peptides, where we can
pioneer the concept of improving current and future drugs via
chemical glycosylation.» Dr. José de Chastonay, CMO Bachem
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GLYCOPEPTIDE APIs BY CHEMICAL SYNTHESIS
The goal is to improve physicochemical properties of peptides
through selective glycosylation
• Both chemical structure and position of glycosyl moieties can markedly
improve the biological activity of a peptide.
• A comprehensive library of glycans, containing human glycoproteins
linked to asparagine, has been created.
• Well-defined glycosylated structures can be generated through chemical
synthesis, which allows optimal choice of the glycosyl moiety and its
position.
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GENERIC APIs
BIOTECHS AND PHARMACEUTICAL COMPANIES
• Trusted supplier
• Strong reputation for sustained
quality & supply
• Long term collaborative partnerships
• Generic APIs are available from
stock in commercial quantities
Peptide
&
Small Molecule
Generics
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WE ARE YOUR TRUSTED PARTNER
LONG-TERM RELATIONS
PRODUCT SUPPLY AGREEMENT WITH
Goserelin AstraZeneca (Great Britain)
Triptorelin Debiopharm (Switzerland)
Nitisinone Swedish Orphan (Sweden)
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REGULATORY AFFAIRS SUPPORT
OVER 80 ACTIVE DMFs AND 15 CEPS WORLDWIDE
Active DMFs
worldwide*
*Please inquire for country specific information
“It has been a great experience
working with Bachem. They offer a
large collection of products with
consistent high quality and have
been a very responsive and
engaged partner.”
Big Pharma Company
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*All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.
Atosiban DMF
Aviptadil DMF
Bivalirudin* DMF
Buserelin DMF
Calcitonin (salmon) CEP, DMF
CRF Trifluoroacetate (human, rat) DMF
Desmopressin Acetate CEP, DMF
Exenatide* DMF
Glucagon DMF
Gonadorelin Acetate CEP, DMF
Goserelin Acetate CEP, DMF
GRF Acetate (human) DMF
Histrelin Acetate DMF
Leuprolide Acetate CEP, DMF
Octreotide Acetate DMF
Teriparatide Acetate,
pTH (1-34) (human) DMF
Secretin Hydrochloride (porcine) DMF
Somatostatin CEP, DMF
Tetracosactide DMF
Triptorelin Acetate DMF
Triptorelin Pamoate DMF
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PEPTIDE GENERIC APIs
*All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.
COMING SOON
Products under
development &
potential candidates
• Lanreotide*
• Liraglutide*
• Lixisenatide*
• Pasireotide
Acetate*
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SMALL MOLECULE GENERICS
*All APIs that are sold for development of drug products still patent protected are offered under Bolar Exemption only.
Antazoline Hydrochloride DMF
Antazoline Phosphate DMF
Antazoline Sulfate DMF
Carbidopa CEP, DMF
L-Cysteine Hydrochloride Monohydrate
Econazole Sulfosalicylate
Etomidate CEP, DMF
L-Ornithine α-Ketoglutarate Monohydrate DMF
Pergolide Mesylate CEP, DMF
Perindopril Erbumine CEP, DMF
Propofol CEP, DMF
Trimetazidine Dihydrochloride CEP
Xipamide DMF
Zolpidem Tartrate CEP coming soon
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LARGE SCALE MANUFACTURING AT BACHEM
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LARGE SCALE
1000 L SPPS reactor
Scale: 8-35 Mol SPPS
MEDIUM SCALE
75 / 150 L SPPS reactor
Scale: 0.75 - 7 Mol SPPS
MANUFACTURING CAPABILITIES SOLID PHASE PEPTIDE SYNTHESIS
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Three story cleavage unit, especially designed for peptide resin cleavage
MANUFACTURING CAPABILITIES CLEAVAGE (I)
250 L vessels for cleavage Filters to filter off
polystyrene resin
1000 L precipitation
vessel
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MANUFACTURING CAPABILITIES CLEAVAGE (II)
CLOSED & CONTAINED PEPTIDE ISOLATION
• Fully contained operation
• Improved filtration
Inverting filter centrifuge Heinkel HF600.1
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PREPARATIVE HPLC
• Columns 5, 20, 30, 59 cm (diameter)
• Scalable processes
MANUFACTURING CAPABILITIES PURIFICATION (I)
20cm Ø HPLC 59cm Ø HPLC
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MANUFACTURING CAPABILITIES PURIFICATION (II)
• ELUENT BUFFER TANK
FARM
• Equipped with weighing cells for
automated buffer preparation
• Jacketed for temperature control
• Control unit guarantees optimal
operation: expiration date,
minimal volume, etc.
2000 L stainless steel tanks
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MANUFACTURING CAPABILITIES PRODUCT ISOLATION
BATCH LYOPHILIZATION
• 6 freeze dryers with
‒ 4.6 m2 (49.5 ft2) shelf area
‒ 150 kg (39.6 gal) ice condenser
capacity
• 9 freeze dryers with
‒ 2.3 m2 (24.8 ft2) shelf area
‒ 100 kg (26.4 gal) ice condenser
capacity
• Located in clean rooms
• All equipment qualified (cGMP)
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MANUFACTURING CAPABILITIES ANALYTICAL TECHNIQUES
Ultra-High-Performance Liquid Chromatography (rapid HPLC, UHPLC) is
used as the standard analytical LC method for IPC and release testing
TECHNIQUES
AVAILABLE
• Amino Acid Analysis
• Bioburden
• Endotoxins
• Ion Exchange HPLC
• Mass Spec
• RP-(U)-HPLC
• SCX-HPLC
….and much more
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BACHEM PIONEERING PARTNER FOR PEPTIDES SINCE 1971
• Independent CMO with >40 years proven track record of peptide
innovation and manufacturing expertise
• Our products and services support our partners through all stages of
drug development
• Highest industry standard for quality assurance, control, and regulatory
compliance
• Excellent project management record with the world’s leading
pharmaceutical and biotechnology companies
• Sustainable long-term partnership with all stakeholders
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Thank you for
your attention