GET Lyo Solutions

GET LYO SOLUTION A ONE-STOP-SHOP FREEZE DRYING GILYOS, Explicat Pharma, and Tempris, three independently operating companies, have formed the strategic alliance GET Lyo Solutions to support your product development, manufacturing and market approval in the field of pharmaceutical freeze drying. The members of GET Lyo Solutions are all family-owned, medium-sized companies. We are all experts in our field and have decades of experience, along with successful (proven) track records. What you can expect from us: a One-Stop-Shop solution using our tremendous network to achieve the desired project goals. Our capabilities range from early development of a drug candidate through its market approval. What you can't expect from us: promises we can't keep. “To know that we know what we know, and to know that we do not know what we do not know, that is true knowledge” - Nicolaus Copernicus

NS, P FOR BENEFIT from our more than 20 years of experience in pharmaceutical freeze drying, both in an academic and industrial environment. GILYOS applies the most recent, highly innovative equipment and instrumentation in their laboratories. OUR PRECISION, quality and solution driven approaches translate into your success. THE GILYOS PHILOSOPHY: "RIGHT FIRST TIME“ BENEFIT from a team of comprehensive industrial experience for various galenical developments. EXPLICAT combines state-of-the-art CMC project management, Quality-by-Design (QbD) approaches, and regulatory strategies. THE EXPLICAT PHILOSOPHY: "IF YOU HAVE AN EARLY LYO DEVELOPMENT CANDIDATE, WE TAKE OVER FULL RESPONSIBILITY AND GET IT ON THE MARKET" BENEFIT from the only one of its kind developer and manufacturer of truely wireless and battery-free temperature measurement systems for freeze drying. TEMPRIS is a technology which represents straightforward Process Analytical Technology (PAT) for freeze drying. Tempris can be applied on all sizes of freeze dryers, i.e., from laboratory up to large scale production. THE TEMPRIS PHILOSOPHY: "EASIFY YOUR LYO PROCESS" TEMPRIS EXPLICAT PHARMA GILYOS

GILYOS WORLD OF FREEZE DRYING GILYOS applies the most recent, highly innovative process and analytical equipment and instrumentation related to freeze drying in their labspace. We are more than an end-user of equipment. We partner with industry leaders to develop technologies that extend the understanding of freeze drying processes. Innovations are central to progress for us. BENEFIT from more than 20 years of experience in the field of freeze drying, both in an academic and industrial environment. S2 laboratory infrastructure to develop formulations and processes under real conditions; approved to handle genetically modified organisms (GMOs) up to biosafety level 2 (S2) Formulation development (liquid, lyophilized) of small molecules, proteins, peptides, vaccines, nanoparticles, polyplexes, ATMPs, GMOs and other complex (drug delivery) systems Excessive experience in thermal characterization of developed formulations (MDSC, LT-FDM, and other techniques) Selection of optimum primary packaging material (vial, syringe, etc.) Freeze drying cycle design and and optimization using state of the art Process Analytical Technology (PAT), controlled nucleation strategies, and QbD concepts Turnkey expertise in physicochemical characterization of freeze dried products (e. g. XRPD, KF, DVS, BET, SEM, and many more) Stability testing at ICH conditions Troubleshooting of existing cycles CMO identification Scale-up, scale-down, and technical transfer of freeze drying cycles Support in selection (specification) of your new freeze drying equipment (lab to production range) Expert consulting and training (LyoscopediaTM)

EXPLICAT PHARMA PROVIDING THE MISSING PIECES EXPLICAT stands for a long history and excessive experience in technical project management. Our broad range of services provide innovative solutions. EXPLICAT has a proven track record in providing the missing pieces, no matter how „puzzling“ your pharmaceutical, medical device, cosmetic, or food supplement development programm is envisioned. BENEFIT from the expert knowledge formed through numerous successful development projects and market approvals. Full range of technical project management Pharmaceutical development Formulation development Technical due diligence Process Analytical Technology Audits Validation and qualification services QA review Consulting and advisory services for GMP Qualified person (QP) services

TEMPRIS REVOLUTIONIZE YOUR LYO PROCESS MONITORING TEMPRIS is a highly innovative technology for real-time product temperature measurement using a wireless sensor system without battery. TEMPRIS was developed in close collaboration with leading pharmaceutical companies and universities in Europe and the United States. TEMPRIS is true PAT for freeze drying: literally the same Tempris sensors can be used both in laboratory scale (development) and production scale (routine manufacturing) freeze dryers under cGMP. TEMPRIS was the first of its kind temperature monitoring technology on the market and is until today, not linked to any equipment vendor. Real-time product temperature monitoring with multiple sensors Hot & cold spot monitoring Freeze drying cycle optimization Scale-up, scale-down & recipe transfer Tempris data serve for regulatory submission filing Fully automatic control with Tempris technology, enabling CPV Expert support for engineering solutions to allow seamless process integration

GILYOS EXPLICAT TEMPRIS WHAT GET MEMBERS HAVE IN COMMON & THE PROMISE TO OUR CLEINTS: GET QUALITY: All members of our alliance are equally dedicated to quality and share the passion for continuous improvement, "Made in Bavaria". GET FLEXIBILITY: The strong relationship between the companies, their small size and flat organization structures ensure short and informal communication channels and rapid decisions. This gurantees a very fast project progress when working with our clients. GET INNOVATIONS: All member companies are well-recognized and have proven track record that they explore novel, unconventional ideas and disruptive approaches. We like to think outside the box to find the optimum solution. GET INDEPENDENT: None of the member companies is linked to, or depen- dent on a vendor, manufacturer or any other company. We select a CMO for your product based on the product's scientific needs and performance attri butes.

GET IN CONTACT & VISIT OUR WEBSITE Tempris GmbH Industriestraße 7 D-83607 Holzkirchen Phone: +49 8024 47447-0 Email: Explicat® Pharma GmbH Georg-Knorr-Straße 4 D-85662 Hohenbrunn Phone: +49 8102 72785-0 Email: GILYOS GmbH Friedrich-Bergius-Ring 15 D-97076 Würzburg Phone: +49 931 90705678 Email: