Cold Chain Technologies

The KLOCKE GRUPPE is a group of consolidated companies, working in the field of contract manufacturing and contract packaging.

The KLOCKE GRUPPE was founded in 1963 by the Klocke family, and whose third generation family members continue today to lead the Group. The path from a packaging company in southwest Germany to a global operating pharmaceutical service provider has been a half century story of innovation and sustainable thinking.

Thanks to the trust and loyalty of all stakeholders, the Group has secured an excellent market position. More than 2.200 employees all over Europe and North America have committed to the Group and help to outperform market expectations every day.

Locations:
Klocke Verpackungs-Service GmbH in Weingarten, Germany
Klocke Pharma-Service GmbH in Appenweier, Germany
Klocke France in Strasbourg, France
Klocke of America in Fort Myers, USA
IDT Biologika GmbH in Dessau-Roßlau, Germany
IDT Biologika (Riems) in Greifswald, Germany
IDT Biologika Corporation in Rockville, USA
Oncotec Pharma Production GmbH in Dessau, Germany

Core activites of the KLOCKE GRUPPE are:
- Manufacturing and packaging of solid dosage forms for pharmaceutical, medicinal and nutraceutical products
- Packaging of semi-solid and liquid forms for cosmetic, nutritional and chemical products
- Development and manufacturing of human and veterinary vaccines
- Aseptic manufacturing of liquids and lyophilized pharmaceutical products
- Research, development, manufacture and distribution of animal health biologics
- Biopharmaceutical analysis and laboratory services

KLOCKE bulk production:
- Mixing and Granulating
- Hard capsules
- Tablets & Coating
- Aseptic liquids & lyophilisates

KLOCKE packaging:
- Blisters (Solids & Liquids)
- Sachets
- Prefilled Syringes
- Jars & Bottles (Solids)
- Vials & Ampoules
- Secondary packaging

Sonoco ThermoSafe is the leading global provider of temperature assurance packaging for the safe and efficient transport of pharmaceuticals, biologics, vaccines & other temperature-sensitive products.

This channel is intended only for US and Canadian visitors. The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada. An unaffiliated and unrelated company, Merck & Co. holds the rights in the trademark MERCK in the US and Canada.

Bringing pharma and biopharma healthcare solutions to life is complex, requiring specialist knowledge and expertise at every step.

This is why MilliporeSigma offers the BioReliance® portfolio – an offering of exceptional, risk-mitigating approaches, testing, critical services and customized, complete solutions to help you bring life-changing drugs to market, faster. We are a leading GMP and GLP testing services provider for the development of your therapeutics. Regulatory bodies such as the US Food & Drug Administrators (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) require products to be tested for compliance before release. With locations worldwide, we offers more than 1,000 tests and complementary services related to biologics safety testing and specialized toxicology. For more information, visit www.bioreliance.com.

Fast-Track Drugs and Biologics, LLC is a contract research organization (CRO) providing strategic planning, clinical trial and regulatory support services to the pharmaceutical and biotech industries for the development and licensure of vaccines and therapeutics for human diseases.

Fast-Track's mission and commitment to our clients is to identify the critical path of pre-clinical and clinical studies and to implement projects required to quickly move products through the development process.

Fast-Track's critical path planning approach ensures our clients the most expedient pathway through the regulatory process with the shortest timeline to product licensure.

Quality Assistance S.A. is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products.

We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences.

For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs.

Quality Assistance S.A. is an expert for the development of:
- Biologics (monoclonal antibodies, ADCs, proteins)
- New Chemical Entities, oligonucleotides, peptides
- Nanomedicine products
- Vaccines
- Cell-Based and Gene Therapy Medicinal Products

The company holds a unique position on the market with:
All its laboratories on one site (Donstiennes, Belgium)
- Bioanalysis (PK/TK/Immuno)
- Bioassays
- Biochemistry
- Chromatography
- Elemental Impurities
- Mass Spectrometry
- Microbiology
- Molecular Biology
- Protein Characterisation
200 highly qualified professionals
more than 35 years’ expertise at the forefront of analytical sciences.

Our core competencies are:
QUALITY (CMC)
- Development and validation of analytical methods
- Characterisation
- Stability studies
- Batch (release) testing
SAFETY/EFFICACY (Bioanalysis)
- Development and validation of bioanalytical methods
- PK/TK studies
- Immunogenicity studies
- Biomarker studies

The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Visit www.quality-assistance.com for more information