Advanced therapies

The challenges of analyzing process-related impurities facing developers of advanced therapies and bacteriophages are unique and remarkably complex.

Now, Alphalyse is delivering a new era of process-related impurity analysis based on mass spectrometry (LC-MS). Our unique solutions have finally made LC-MS analysis easy to access – and it is fast becoming the 'must-have' technique for cell & gene therapy analysis.

 

On demand webinar

LC-MS HCP assay validation and GMP release testing for complex samples

An MS-based assay is ideal when the complexity of your therapeutic makes it challenging to find or develop an adequate ELISA. The focus in this webinar is on the analytical methods for characterizing HCPs, residual proteins, viral vector proteins, and other proteins in highly complex products - and use the data for release testing.

advanced therapies

How an LC-MS assay can help you

Bringing absolute clarity to protein impurity analysis

Within weeks, one assay unlocks the identity and quantity of all proteins irrespective of their source, even if they originate from several different host species. The data allows you to understand and control the purification process and ensure consistent product quality, purity, regulatory compliance, and patient safety.

The LC-MS assay is applicable for products based on lentivirus, retrovirus, adenovirus (oncolytic virus), adeno-associated virus (AAV) vectors, bacteriophages (phage therapy), and more.

Host cell protein analysis

Host cell protein analysis

Assess the presence and potential impact of process-related impurities on your product. Identify and quantify residual proteins at each stage of the downstream process to ensure all impurities of concern can be efficiently removed.

Product characterization services

Product characterization services

Gain a thorough understanding of your biotherapeutic product. Optimize your process design and ensure that your product achieves all safety, purity, and potency attributes required by regulatory authorities.

Insight articles

Whatever ELISA-related challenge or question you may have, we are here to help you solve it. One of our protein analysis experts will discuss the best analysis approach or method for your project by email or online meeting – without obligation.

product quality in C&GT

Ensuring process consistency and product quality in C&GT

As industry regulators increasingly request data quantifying host cell and viral proteins, orthogonal analysis methods become more critical. We examine why LC-MS is likely to become the gold standard.

FDA requests increased product consistency

FDA requests increased product consistency of C&GTs - better analytics required

Find out how LC-MS can address increasing demands from the regulatory agencies for documentation of quality attributes in C&GTs.

Adonovirus

Why you should worry about process-related impurities in C&GTs development

In light of newly-updated regulatory guidelines for process-related impurity monitoring, we discuss the reasons why SWATH LC-MS is the superior analytical choice for process-related residuals.

Insight articles

Whatever ELISA-related challenge or question you may have, we are here to help you solve it. One of our protein analysis experts will discuss the best analysis approach or method for your project by email or online meeting – without obligation.

insight-articles-blue

Ensuring process consistency and product quality in C&GT

As industry regulators increasingly request data quantifying host cell and viral proteins, orthogonal analysis methods will become more critical. We examine why LC-MS is likely to become the gold standard.

insight-articles-blue

The FDA requests increased product consistency of C&GT manufacturers - better analytics required

Find out how LC-MS can address increasing demands from the regulatory agencies for documentation of quality attributes in C&GTs.

insight-articles-blue

Why you should worry about process-related impurities in C&GTs development

With newly published regulatory guidelines for process-related impurity monitoring, we discuss the reasons for using SWATH LC-MS for analyzing these process-related residuals.

Looking for inspiration?

Client success stories

Client success stories

ELISA characterization and coverage analysis

Webinars and videos

Protein analysis laboratory

Literature

What clients say

Testimonial Alphalyse
“We found out why our PG13 ELISA kit had such low coverage of our gene therapy’s HCPs”

Chief Scientific Officer
Top10 Pharma Company
Testimonial Alphalyse
"The mass spec results were extremely detailed and almost identical between replicates and can probably replace ELISA as the HCP analysis approach for our future C&GT projects"

Chief Scientific Officer
European biopharma company
Testimonial Alphalyse
"With the Gag to Gag-Pol ratio determined, we can monitor the consistency of viral capsid formations in our lentivirus-based product"

Head of CMC, C&GT division
UK pharma company
Testimonial Alphalyse
"We now use a mass spectrometry assay to follow the reduction of specific A549 HCPs in our downstream process"

Sr. Research Associate
US-based C&GTs developer
Testimonial Alphalyse
"Honestly, we were astonished to see the mass spec results: The detailed report enables us to optimize our CMC process and remove specific HCPs if we find it relevant."

Director, Regulatory CMC
Oncology-focused biopharmaceutical company
Aicuris logo
"Alphalyse provided a very well-designed and executed HCP analysis, fruitful technical discussions, and flexibility in terms of writing the report."

Thore Schmedt, Associate Director
AiCuris Anti-infective Cures AG, Germany
Targovax logo
"They handled the project professionally and rapidly, and the report was very well written, clearly explaining the findings."

Kristiina Hyvärinen, Director QC, viral products
Targovax ASA, Finland

LC-MS analysis works for all expression systems

Mammalian expression lines

Mammalian

Hamster
    CHO, BHK
Human
    A549, CAP®,
    HEK293, HEK293T,
    HeLa, Hep G2, HKB
    11,HT-1080, HuH-7,
    MCF-7, MRC5,
    PER.C6®, U-2 OS, Y79
Monkey
    Vero
Mouse
    CAD, C127, GS-NS/0,
    J558L, L929, NS/0,
    3T3, NIH-3T3, P19,
    PG13, Sp2/0
Dog
    MDCK

Bacterial host cells

Bacterial

E. coli
Staphylococcus
    S. aureus
    S. caprae,
    S. epidermidis
    S.lugdenensis
Enterococcus
    E. faecalis
    E. faecium
Pseudomonas
    P. Aeruginosa
    P. fluorescens
A. baumannii
B. subtilis
B. choshinensis
L. lactis

Yeast expression system

Yeast

P. pastoris
S. cerevisiae
S. pombe
H. polymorpha

Insect expression systems

Insect

S. frugiperda
    Sf9, Sf21
Drosophila
    Schneider S2
Trichopulsia ni (Tni)
    High Five™ (Hi5)
A. californica

Plant expression system

Plant

N.benthamiana (tobacco)
    BY-2 and VBI-0
P. patens (moss)
    Oryza sativa (rice)

Curious to know more?

Leading edge technologies

We offer customized solutions, contact us to discuss your project.

FAQ

Regulatory standards and clinical administration require thorough documentation of quality attributes pertaining to drug product identity, purity, potency, stability, and safety. However, the high complexity of C&GTs poses a considerable challenge for impurity and product characterization strategies.

Unlike traditional biologics, which are typically manufactured by expressing one recombinant protein in a single cell line, advanced therapies contain highly heterogeneous protein mixtures from multiple sources and organisms. Traditional biologics also have well-defined manufacturing processes supported by established analytical methods, whereas the manufacturing processes for cell & gene therapies are often still in development.

Improved analytical tools, such as mass spectrometry (LC-MS), ensure process consistency and quality and meet regulatory requirements for product release and characterization.

Talk to us

Whatever protein-related challenge or question you may have, we would love to help. Our experts can help you decide on the best analytical approach for your project by email or online meeting - providing advice without obligation.

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