PolyPeptide Group — a Contract Development &Manufacturing Organization. Your flexible, transparent
and technically innovative partner from the simplest tothe most complex peptides

COMPANY PROFILESOLUTIONSTh e Poly Pe p ti de G r ou p i s a p riv a t e l y - h e l d C o n t ra c t D e v e l o p m e n t &Man u factu r i n g Or g a n i za ti on ( C D M O ) w h ic h f o c u s e s o n p ro p rie t a ry andgen er ic G M P- g r a de p e p ti de s f o r t h e p h a rm a c e u t ic a l a n d b io t e c h no l o gymar kets.
As one of the world’s largest independent contract manufacturers of therapeutic peptides, the Group
manufactures over one third of all approved peptide drug substances. With six GMP facilities worldwide, a leading
position in its field with a focus on pharmaceutical peptide manufacture, PolyPeptide Group offers its customers coreexpertise and an unprecedented long-term security of supply.

R&DFrom_ Small Scale_ Research Grade_ Custom Peptides_ Radiolabeled Peptide

We offer flexibility in production scale frominitial gram quantities to commercial
requirements of multi-kilograms or more perbatch.

P re -Clinica l Ma nufa cturingConception toCommercialization_ Preclinical and Toxicology Batches_ Process Development_ Analytical Method Development

G MP Pha se I to Pha se III_ Drug Substance Supply_ Process Scale Up & Optimization_ Process Qualification and Validation_ Analytical Method Qualification and Validation_ CMC Documentation

KEYFACTS

A pprova l_ Regulatory Support_ DMF, ASMF, COSs, ...
_ Pre-Approval Inspection

6Manufacturing Facilities
Worldwide
More thanOu r missi on is to create customer satisfaction and foster long-term customer loyalty through excellence in peptide
technology, quality, value, service and customer support.

Ou r goa l is to assist our clients at every step of productdevelopment; from early stage development to commercial
GMP grade manufacturing.

Ou r cu st ome r s are our focus. We strive to be yourpreferred partner from simple to complex peptide manufacturing by consistently providing you with the highest quality
products and services.

2800Employees

From the Simplest tothe Most Complex Peptides

Co m mercia l Ma nufa cturing_ Small to Large Scale_ Commercial Batches_ Peptides for Diagnostic Applications_ Peptides for Cosmetic Use

Total Commitment toQuality
60

Overyears’ experienceof manufacturing API’s

30

G eneric Peptides_ For Human and Veterinary Markets_ Available for your needs_ Regulatory Documentation (DMF, ASMF,COSs,...)

approved peptide-based API’s

3

PRODUCT PORTFOLIO

GMP services

Generic API Portfolio

The Manufacture of GMP grade peptides is the core business at
PolyPeptide Group. With over 1000 peptides manufactured underGMP conditions within the Group, we offer the expertise to develop the most efficient processes to design, cost-effective andsustainable production.

The PolyPeptide Group manufactures a large range of generic
peptide APIs at commercial scale for the human and veterinary
markets.
Our Generic APIs are used for many different Therapeutic areas,such as:Custom Peptides for
R&D & Lead Optimization_ Endocrinology, musculoskeletal_ Pediatrics_ Obstetrics, gynecology_ Anesthetics_ Cardiovascular diseases_ Nephrology_ Veterinary_ And more...

The PolyPeptide product line includes manufacture ofcustom research grade peptides, stable and radioactive
isotope labelled peptides and peptidomimetic molecules.

Cosmetics
Peptides are important ingredients in global cosmetic
products and international brands, primarily for anti-aging applications. Peptides have various cosmetic
benefits and each peptide used in products has a specificactivity; firming, anti-wrinkle, anti-irritation and reduction in pigmentation. Our long standing experience ofclinical grade peptide manufacture applies equally tocosmetic peptides. PolyPeptide adapts the quality standards to the cosmetic market needs.

4CommercialManufacturing
The PolyPeptide Group produces one third of the commercially approved peptides in the world. Our experience in processdevelopment, manufacturing scale up, and regulatory filing makes us
a trusted and reliable partner, a key benefit to our clients.

5

GLOBAL SUPPORT FOR A QUALITY SOLUTION

Technology& Innovation
Continuous improvement of Peptide Ma­nufacturing: theoptimization of existing techniques, introduction of newtechnologies, im­plementation of greener processes, in line monitoring and automation are integral to the group’s growth and sustainability.

Quality
Our goal is to design and develop manufacturing processes able toreproducibly generate product of consistent quality. Quality is also part of every
step of our development process; from preliminary interactions with customers
prior to the start of a project through to later phase discussions and ongoing communication and support after product delivery.
Qua­lity continues after product release, with supporting stability studies, andassisting clients with regulatory filings.

With our industry leading position, we have created a strong international network to iden­tify, develop and promote new concepts
on disruptive technologies that will significantly impact the way wedevelop and produce peptides in the near future.

Regulatory Support
Regulatory requirements for peptide drug substances are unique andcontinually evolving. The PolyPeptide Group has the experience and theknowledge to assist and advise its customers through every step andchange in the regulatory approval cycle. PolyPeptide Group’s regulatory
support includes preparation of all documents related to the drug substance required by the regulatory authorities. Regulatory support also
includes assistance in meetings with regulatory agencies and, preparationof responses to questions from regulatory authorities in connection withthe review of regulatory submissions.
To learn more about our experiences and the PolyPeptide Group, please
visit www.polypeptide.com

67

Limhamn, Sweden
Braine-l’Alleud, Belgium
Torrance, CA

Strasbourg, France

San Diego, CA

ID Interactive - www.id-interactive.fr - Oct. 2019

Ambernath, India

P o l y P e p t id e G ro u p

Chaussée de Tubize 297
1420 Braine-l’Alleud
Belgiumbraine@polypeptide.com
Tel +32 2 386 2909
Fax+32 2 386 2994

7 rue de Boulogne
67100 Strasbourg
Francestrasbourg@polypeptide.com
Tel +33 388 790 879
Fax +33 388 791 856

Plot No. K-28, Additional MIDC,
Anand Nagar, Ambernath (East)Thane 421 506, Maharashtra
India
mumbai@polypeptide.com
Tel +91 251 2628600
Fax +91 251 2620860

Limhamnsvägen 108
216 13 Limhamn
Swedenscandinavia@polypeptide.com
Tel +46 40 366 200
Fax +46 40 366 386

9395 Cabot Drive
San Diego, CA 92126
USAsandiego@polypeptide.com
Tel +1 858 408 0808
or +1 800 338 4965
Fax +1 858 408 0799
or +1 800 654 5592

365 Maple Avenue
Torrance, CA 90503
USAtorrance@polypeptide.com
Tel +1 310 782 3569
or +1 800 770 0557
Fax +1 310 782 3645

w w w . p o l y p e p t id e . c o m